EXAMINING EFFICACY, MECHANISMS, AND INTERVENTION FIDELITY OF 
MINDFULNESS-BASED COGNITIVE THERAPY  FOR ANXIETY AND STRESS 
REDUCTION AMONG COLLEGE STUDENTS IN A RANDOMIZED CONTROLLED 
TRIAL 

By 

Oksana K. Ellison 

A DISSERTATION 

Submitted to 
Michigan State University 
in partial fulfillment of the requirements   
for the degree of 

Kinesiology– Doctor of Philosophy 

2023 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSTRACT 

The prevalence of anxiety and stress among college students necessitates the 

investigation of potential alternative and accessible interventions that could be implemented into 

existing curricular and student-support programming to improve students' mental health. While 

mindfulness-based cognitive therapy (MBCT) smartphone applications have shown promising 

outcomes in alleviating anxiety and stress, it is essential to gain insight into the feasibility and 

efficacy of such an interventional approach in a collegiate population; as well as explore 

potential underlying mechanisms which could be better targeted to enhance the efficacy of future 

interventions for promoting mental health and well-being.  The aim for this study was to assess 

the efficacy of a 4-week MBCT intervention using the Sanvello smartphone application in 

reducing trait-level anxiety and chronic stress in college-aged young adults (n = 150) compared 

to a positive control group (n=139). Participants completed assessments of trait anxiety, chronic 

stress, cognitive reappraisal, cognitive refocusing, distractive refocusing, and negative automatic 

thoughts at pretest and following 4 weeks of the interventions. Analysis of primary outcomes 

revealed greater reductions in trait anxiety and chronic stress for the MBCT group, relative to the 

positive control group with small to moderate effect sizes. The anxiolytic and stress-reducing 

effects of the MBCT intervention were observed to be mediated by changes in negative 

automatic thoughts but not by changes in cognitive reappraisal, constructive refocusing, or 

distractive refocusing. Given the efficacy of the Sanvello smartphone application and the 

overwhelmingly strong assessments of the appropriateness and feasibility of it use; student 

support initiatives may be well served by adopting such a platform within the context of first-line 

treatment and prevention of high anxiety and chronic stress within first year college students.  

 Keywords: Mindfulness-Based Cognitive Therapy, Cognitive Restructuring, Negative Automatic 

Thoughts   

iii 

 
 
 
 
 
 
 
 
TABLE OF CONTENTS 

CHAPTER 1: Introduction ..............................................................................................................1 

CHAPTER 2: Review of Literature  ................................................................................................7 

CHAPTER 3: Methodology ...........................................................................................................20 

CHAPTER 4: Results ....................................................................................................................30 

CHAPTER 5: Discussion ...............................................................................................................35 

REFERENCES ..............................................................................................................................47 

APPENDIX A: IRB Letter ............................................................................................................54 

APPENDIX B: Dissertation Funding Source  ...............................................................................60 

iii 

 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
CHAPTER 1: Introduction 

According to the American College Health Association (2019), over two-thirds of 

collegiate women and half of collegiate men experience a high prevalence of anxiety-related 

symptoms. Further, over half of students indicate moderate levels of chronic stress that adversely 

affects their daily functioning (Li et al., 2022). Compounding this, over the past several decades 

there has been a pervasive rise of violent incidents and mass shootings within US schools 

reducing student perceptions of well-being and exacerbating stress and anxiety (Fox & Fridel, 

2018; Katsiyannis, Whitford, & Ennis, 2018; Levine & McKnight, 2020). These findings 

highlight the crucial need for effective interventions to address the heightened levels of anxiety 

and stress observed in college students. Although in-person mindfulness-based cognitive therapy 

approaches have been found effective for reducing anxiety and stress (Haller et al., 2021; Irving 

et al., 2009; Phang et al., 2016; Ozen et al., 2013; Kor et al., 2019); given the pervasiveness of 

anxiety and stress in this population existing support services are overwhelmed, thus there is a 

need to provide alternative and accessible interventions to improve students' mental health 

(Addis, Wade and Hatgis, 1999; Joyce et al., 2009; Newman et al., 2022). One such approach 

may be by leveraging existing tools such Sanvello — a free mindfulness-based cognitive therapy 

smartphone application — which could more easily be deployed across a broader population and 

potentially even implemented into existing curricular and student-support programming. 

However, prior to such implementation it is essential to gain insight into the feasibility and 

efficacy of such an interventional approach; as well as explore potential underlying mechanisms 

which could be targeted to enhance the efficacy of future interventions for promoting mental 

health and well-being.    

1 

 
Mindfulness-based interventions entail cultivating mindful awareness by attentively 

observing experiences, thoughts, and emotions (Lao et al., 2016; Gu et al., 2015). The most 

common and well-known interventions in this area are mindfulness-based stress reduction 

(MBSR) and mindfulness-based cognitive therapy (MBCT). MBSR encourages the development 

of self-management of stress and emotional distress by becoming more aware of thoughts and 

feelings regarding a particular stimulus or situation (Bishop, 2002). Although there is wide 

variation in the specific practices, a common implementation is through mediation and focused 

breathing exercises whereby the individual is taught to passively observe their thoughts and 

feelings without making judgements or assigning value to them as anything other than brief 

mental events. Further, individuals are encouraged to employ these mediation and focused 

breathing exercises when they experience times of stress or anxiety. Meta-analytic reviews have 

consistently observed beneficial effects of MBSR-based interventions in reducing trait anxiety 

(hedges g = 0.36 to 0.55) and chronic perceptions of stress (hedges g = 0.83 to 1.0) with similar 

effects regardless of the target population being students, healthcare professionals, or the general 

public (Grossman et al., 2004; Khoury et al., 2015; Questret et al., 2020). However, it is 

important to acknowledge persistent limitations within the extant literature on MBSR-based 

interventions relating to small sample sizes, non-random assignment, and the absence of control 

groups (Ludwig and Kabat-Zinn 2008; Philippot and Segal 2009). Indeed, Bohlmeiher and 

colleagues (2010) noted that the anxiolytic effects were reduced nearly in half when excluding 

lower-quality studies. MBCT interventions build upon the same core aspects of MBSR, but also 

integrate elements of cognitive therapy to help individuals recognize and interrupt negative 

thought patterns that can lead to perceptions of anxiety and stress (Kim et al., 2009). Meta-

analytic comparison of MBCT against MBSR, in particular, has shown that interventions using 

2 

 
MBCT exert nearly twice as large of an anxiolytic effect than interventions using MBSR 

(Questret et al., 2020). Nevertheless, a key criticism of mindfulness-based interventions is that 

they are classically delivered through multiple one-to-two-hour sessions over the course of 8 

weeks in an individual or small group format; representing a substantial constraint of both time 

and resources for the individual and clinical practitioners.    

However, emerging evidence indicates that the anxiolytic and stress-reducing effects of 

mindfulness-based intervention programs manifest even when the intervention period is 

shortened. Specifically, Demarzo and colleagues (2017) observed similar effects of both 4-weeks 

(n= 46) and 8-weeks (n=51) of a mindfulness-based intervention program, relative to a non-

contact control group (n=49) in reducing anxiety (cohen’s d = 0.45 and 0.57, respectively) with 

no statistical difference between intervention periods. Although the intervention programming 

implemented by Demarzo and colleagues (2017) still required 120-minute sessions each week 

with an experienced, certified mindfulness teacher; given the ubiquity of smartphones amongst 

college aged students, a promising potential approach is in utilizing smartphone-based 

applications to implement mindfulness-based cognitive therapy (MBCT) interventions.   

While there are a wide-assortment of such applications, the present investigation 

specifically utilized the Sanvello application as it is a cost-free application that was compatible 

with a wide range of Apple and Android devices and thus represents a potential platform that 

could be used within broad segments of the college-student community. Further, there exists 

prior work specifically examining the efficacy of the application on both anxiety and stress. 

Specifically, Moberg and colleagues (2019) observed reductions in anxiety (cohen’s d = 0.4) and 

stress (cohen’s d = 0.46) in users of the Sanvello platform over the course of a 30-day 

intervention. However, it is critical to acknowledge the conflict-of-interest and self-serving 

3 

 
findings associated with Moberg and colleagues being cofounder/chief-executive-officer and on 

salary at Sanvello (formerly Pacifica Labs, Inc.). Further, the investigation specifically recruited 

individuals who were interested in using the Sanvello application or who were already existing 

users; which reflects a substantially different population and context than might be seen if 

deployed within the context of existing curricular and student-support programming in a 

collegiate population. Thus, while there is strong evidence that such implementation of MBCT 

can be effective, there remains an open question as to how feasible and effective such a brief 

smartphone-based interventional approach might be if implemented within a population that is 

not self-selecting to already use the application.    

In contrast to the extensive body of literature examining the effects of mindfulness-based 

interventions, relatively few studies have examined the underlying causal mechanisms 

responsible for inducing changes in trait anxiety and chronic stress. Yet such an understanding is 

vital for providing insight into how to optimize and tailor interventional approaches to maximize 

their impact. Building from Beck's cognitive theory of anxiety and depression (1987), the crucial 

factor in the manifestation and alteration of negative psychological states such as anxiety and 

chronic stress is the emergence of negative thinking patterns. Negative thinking patterns 

encompass cognitive habits that lead individuals to perceive situations in a distorted manner. One 

prominent example of such a pattern is catastrophizing, when individuals tend to assume the 

most dire and pessimistic outcome in any given situation. From a construct-framework 

perspective, mindfulness-based cognitive therapy encourages the development of promoting 

awareness of and control over how an individual assesses a particular stimulus or situation (i.e., 

cognitive reappraisal), reframes/reinterprets the function and/or consequence of the event (i.e., 

constructive refocusing), and becomes accepting of experiences rather than exhibiting the 

4 

 
tendency to dissociate or avoid them (i.e., distractive refocusing) (Garnefski & Kraaij, 2006; 

Gross & John, 2003; Wolgast, Lundh, & Viborg, 2013). The fundamental premise of 

mindfulness-based cognitive therapy is that through the development of such core psychological 

constructs an individual may be better able to recognize and transform their negative automatic 

thoughts, beliefs, and behaviors (Sipe & Eisendrath, 2012). Accordingly, given such a 

framework, these core psychological constructs are presented as causally implicated in the 

effects of a MBCT intervention on trait anxiety and chronic stress. The present investigation 

sought to specifically examine these constructs as potential mediators of the anxiolytic and 

stress-reducing effects of MBCT.  

Accordingly, the present study provides a novel contribution to the literature by 

addressing the following research questions: (1) What is the efficacy of a 4-week MBCT 

delivered through the Sanvello smartphone application for reducing trait-level anxiety and 

chronic stress, relative to control group, implemented within the context of a predominately first 

year-level collegiate course following a mass-shooting incident on campus. (2) To what extent 

do cognitive restructuring domains (cognitive reappraisal, constructive refocusing, and 

distractive refocusing) and negative automatic thoughts mediate the anxiolytic and stress 

reducing effects of the MBCT intervention. And (3) to what extent do intervention fidelity 

domains (implementation, dose, quality) moderate the efficacy of the 4-weekMBCT for reducing 

trait-level anxiety and chronic stress. Based upon the extant literature, it was hypothesized that: 

(1) Engaging in the MBCT intervention would result in a greater reduction in trait anxiety and 

stress compared to the positive control group. Drawing upon Beck's cognitive theory of anxiety 

and depression (Beck, 1987) and the conceptualization of the construct-framework perspective, it 

was hypothesized that (2) greater changes in cognitive reappraisal, constructive refocusing, and 

5 

 
distractive refocusing would each mediate the changes in anxiety and stress induced by the 

MBCT intervention, with the strongest mediation effect observed for negative automatic 

thoughts. It was also hypothesized that (3) fidelity domains would exert a moderating influence 

on changes in anxiety and stress induced by the MBCT intervention.  

6 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
CHAPTER 2: Review of Literature 

To gain a comprehensive understanding of the relationship between mindfulness practice 

and anxiety reduction, a review of the existing literature concerning both topics is necessary. 

This chapter will provide insights into mindfulness practices and their potential mechanisms for 

reducing anxiety. The discussion will cover the following aspects: (1) the duration and frequency 

of mindfulness, (2) justification for online application, (3) the cognitive theory of anxiety and 

depression as a theoretical framework, and (4) the mechanism of cognitive restructuring. 

Mindfulness 

In the past six decades, Buddhist traditions have taken root in the Western world (Fields, 

1992; Bishop, 2004). Mindfulness, a contemplative practice, is based on the Buddhist belief in 

the impermanence of all things, the absence of an enduring self, and the concept of suffering 

caused by clinging to the illusion of a permanent self, also known as the "three marks of 

existence" (Bodhi, 2003). Mindfulness-based interventions differ from typical Western 

psychological assumptions in three main ways: 1) they focus on changing people's state of 

consciousness rather than the contents of consciousness, leading to reduced suffering; 2) they 

consider interpreting experiences in relation to the self-concept as detrimental; and 3) they 

emphasize the present moment as the only existing point in time, cautioning against attempts to 

overly orient oneself to the present (Rosch, 2007). 

Mindfulness as a Technique 

Mindfulness techniques involve non-judgmental attention to the present moment, 

becoming aware of sensations, thoughts, and feelings without giving them undue significance. In 

the Buddhist concept of mindfulness, there are two components: concentration (samatha) and 

insight (vipassana). Samatha technique focuses on the object of meditation, while vipassana 

7 

 
 
involves observing impermanence, suffering, and not-self. Though often confused in 

psychological discussions on mindfulness, these two concepts have distinct implications for the 

outcomes of mindfulness practice. Empirical evidence and theory support the idea that 

mindfulness techniques lead to a lasting change in perspective and state of being (Brown & 

Ryan, 2003; Brown et al., 2007a, 2007b; Carmody et al., 2009; Gunaratana, 2011; Hollis-Walker 

& Colosimo, 2011; Kabat-Zinn, 1982; Leary et al., 2006). 

Empirical Research on Mindfulness-Based Interventions 

Various mindfulness-based interventions have been developed for incorporation into 

treatment plans tailored to individuals (Didonna, 2009). Due to their widespread utilization, it is 

crucial to conceptualize the possible mechanisms through which these therapies are effective 

when applied to various mental health disorders. 

Mindfulness-Based Stress Reduction (MBSR) 

In the early 1980s, Kabat-Zinn introduced the first mindfulness-based program, 

Mindfulness-Based Stress Reduction (MBSR), initially implemented in a pain clinic to help 

patients manage chronic pain. MBSR is a commonly used mindfulness training method, 

consisting of an 8-10 week course for groups of up to 30 individuals. The participants meet 

weekly to learn and practice mindfulness meditation skills, discuss stress and coping, and 

complete homework assignments. The program includes various mindfulness exercises such as 

body scan, sitting meditation, yoga, and mindfulness during everyday activities (Kabat-Zinn, 

1982). Participants are encouraged to practice these skills for at least 45 minutes a day, six days a 

week, focusing on the present moment and observing things nonjudgmentally. The goal is to help 

individuals realize that sensations, thoughts, and emotions are transient and not to become 

absorbed in their content (Linehan, 1993b, p. 87). 

8 

 
The program involves teaching mindfulness meditation techniques that emphasize 

observing sensations and recognizing their impermanent nature. Kabat-Zinn posits that by 

shifting attention from reactivity to observation, individuals can uncouple the link between 

experiencing pain and the subsequent emotional reaction to it. He suggests that this suspension 

of normal reactions to internal events is a form of therapeutic exposure, leading to increased 

awareness of internal reactivity. However, Kabat-Zinn's explanation lacks a detailed description 

of the underlying psychological processes. A meta-analysis by Grossman et al. (2004), based on 

20 studies, found that MBSR significantly improves mental and physical health, but it did not 

measure changes in mindfulness, indicating a need for further investigation into the underlying 

mechanisms. 

In a study, Shapiro and colleagues (2006) proposed that the core psychological 

mechanism behind Mindfulness-Based Interventions is "reperceiving." They define reperceiving 

as a fundamental shift in perspective that occurs through the mindfulness components of 

intention, attention, and attitude. This shift enables individuals to distance themselves from their 

thoughts and emotions, viewing them as separate from their self. Shapiro et al. (2006) highlight 

that reperceiving leads to decreased identification with one's own thoughts and emotions, thereby 

reducing their power and impact. Negative thoughts may have a weaker link to depression, and 

negative emotions may be less persistent as a result. Additionally, reperceiving leads to a 

realization that the self is a constantly changing concept composed of memories, beliefs, 

sensations, and ideas. By practicing mindfulness, individuals can develop a less egocentric 

worldview and become less attached to the concept of self. This shift in perception can lead to 

increased compassion and concern for oneself and others. Furthermore, it may result in 

decreased distress when the concept of self is threatened, whether the threat is real or 

9 

 
perceived.Segal and colleagues developed Mindfulness-Based Cognitive Therapy (MBCT) in 

2002 as a treatment for depression relapse (Segal et al., 2002). MBCT aims to train attention 

regulation by targeting a pattern of thinking known as "rumination," characterized by repetitive, 

negative thoughts about the causes and consequences of one's distress without resulting in 

problem-solving. 

According to Segal et al.'s model of depression relapse, rumination is established and 

strengthened during the first depressive episode, and relapse occurs when a trigger reactivates 

rumination. The authors propose the concept of "modes of mind" to explain the problematic 

nature of rumination, specifically the distinction between the adaptive "doing" mode and the 

maladaptive "driven-doing" mode. In "driven-doing," the focus is on failing to be the person one 

wishes to be, generating negative feelings and making it difficult to let go of discrepancies in the 

internal arena, thereby perpetuating rumination.The authors suggest that the ruminative loop 

created in the "driven-doing" mode can be disrupted and terminated through learning to 

recognize when it is activated and relating to it with acceptance and nonreactivity while having 

the choice to redirect attention elsewhere. They propose that MBCT teaches skills to exit the 

"doing" mode and enter the "being" mode, using mindfulness meditation and psychoeducation. 

The program aims to improve the relationship with thoughts and feelings through decentering, 

teaching participants to view thoughts as transitory events and not giving them undue 

importance. This realization arises from observing thoughts and feelings nonjudgmentally and 

noting that they arise and pass away. The authors argue that the positive outcomes of MBCT are 

mediated by gains in mindfulness and self-compassion, as measured by the Self-Compassion 

Scale (Neff, 2003); However, the underlying mechanism by which self-compassion works needs 

to be adequately addressed (Kuyken et al., 2010). 

10 

 
The theory behind MBCT is that individuals who have experienced major depressive 

episodes are vulnerable to recurrences when they encounter mild dysphoric states, which can 

reactivate depressive thinking patterns. MBCT aims to prevent depressive relapse by teaching 

individuals to observe their thoughts and feelings nonjudgmentally and to view them as mental 

events that come and go rather than as aspects of themselves or as necessarily accurate 

reflections of reality (Segal et al., 2002). This attitude is believed to prevent the escalation of 

negative thoughts into ruminative patterns and promote mental well-being. 

The National Institute of Clinical Excellence (NICE) recommends MBCT as a treatment 

for preventing relapse in depression, especially for those who have experienced depression three 

or more times (NICE, 2009). A study by Teasdale et al. (2000) found that MBCT halved the 

relapse rate in those who had previously experienced depression three or more times compared to 

treatment as usual. However, the study did not measure levels of mindfulness or its different 

traits in participants, leaving it unclear whether mindfulness is the mechanism of change and 

which aspect of mindfulness is responsible for the effects of the intervention. 

In a study by Kim et al. (2009), the effectiveness of mindfulness-based cognitive therapy 

(MBCT) as an addition to medication in treating patients with panic disorder or generalized 

anxiety disorder (GAD) was investigated. The study included 46 participants who were 

randomly assigned to either an MBCT group or an anxiety disorder education (ADE) group. The 

MBCT group received eight weekly 2-hour sessions of MBCT, while the ADE group received 

eight weekly 2-hour sessions of education about anxiety disorders. The study results showed that 

the MBCT group had significantly more improvement than the ADE group in all anxiety and 

depression scale scores, as well as in the obsessive-compulsive and phobic subscales of the 

symptoms checklist. The MBCT group also showed improvements in quality of life and coping 

11 

 
skills. These findings suggest that MBCT may be an effective treatment for panic disorder and 

GAD in addition to medication, though more research is needed to confirm these findings. 

The effectiveness of mindfulness interventions for reducing anxiety among individuals 

with anxiety disorders has yielded inconsistent findings in previous research (Hofmann et al., 

2010; Khoury et al., 2015; Irving et al., 2009). Some studies have reported significant reductions 

in anxiety symptoms following mindfulness interventions, while others have not. Additionally, 

comparing mindfulness interventions to cognitive-behavioral therapy (CBT) interventions in 

terms of efficacy remains inconclusive (Goldin et al., 2016). However, recent studies suggest 

that mindfulness training can effectively reduce anxiety symptoms compared to other active 

treatments (Khoury et al., 2013). Specifically, Mindfulness-Based Stress Reduction (MBSR) has 

demonstrated efficacy in reducing anxiety symptoms, including anxiety in response to a 

laboratory social stress challenge task, when compared to an active stress-management education 

program group in individuals with generalized anxiety disorder (Hoge et al., 2013). 

Mindfulness and Anxiety 

Studies examining the relationship between dispositional mindfulness and anxiety have 

shown promising results. Higher levels of dispositional mindfulness have been associated with 

lower levels of state anxiety, both in laboratory and class settings (Bellinger et al., 2015). 

Moreover, dispositional mindfulness has been found to mediate the effects of anxiety on 

academic performance, suggesting that individuals with higher dispositional mindfulness may 

experience relatively lower levels of anxiety and perform better on exams (Lopez-Navarro et al., 

2020). Chen et al. (2013) demonstrated that even a brief one-week period of 30 minutes of 

mindfulness practice provided relief from anxiety in undergraduate students. Furthermore, a 

single bout of 3-minute mindfulness training has been shown to reduce anxiety two weeks post-

12 

 
intervention (Lewis et al., 2021). Although these findings suggest promising dosage 

recommendations, further research is needed to explore mindfulness intervention dose-response 

relationships. 

Study Justification  

The question of how much mindfulness intervention is needed to experience benefits has 

been a common inquiry. Current evidence suggests that even brief mindfulness interventions, 

such as 5-10-minute guided mindfulness inductions or 3-4 session mindfulness meditation 

training, can lead to immediate reductions in affective reactivity and impulsive behaviors, 

although the effects are generally small in magnitude. On the other hand, larger doses of 

mindfulness interventions, such as the 8-week MBSR program, have shown moderate-to-large 

overall effects pre-post training (Burgstahler & Stenson, 2019). 

Online Application Justification 

A recent development in the mindfulness literature is the increasing use of internet and 

app-based mindfulness interventions. Smartphone applications for mental health interventions 

have been shown to reduce stigma around seeking treatment and increase access to care (Clough 

& Casey, 2015). While thousands of mental health apps are available, only a limited number 

have undergone rigorous scientific testing. Studies have found that mobile-delivered 

interventions for anxiety show small to moderate effect sizes, with potential improvements in 

study design and reporting of bias to strengthen further the evidence (Gee et al., 2015; Firth et 

al., 2017). Recent reviews also support the efficacy of mHealth apps for mental health, with 

increasing evidence of significant effects (Orsa-Duarte et al., 2021; Krusche et al., 2013). 

Sanvello: Anxiety and Depression (formally Pacifica)  

Sanvello is a commercially available app designed for self-management of stress, 

13 

 
 
anxiety, and depression. The app, which is tailored for individuals with mild to moderate 

symptoms, is informed by the Cognitive Behavioral Therapy (CBT) model and provides 

psychoeducation, mood monitoring, identification of maladaptive thoughts, exposure and 

reappraisal activities, social support, self-care activities, and skills to target physical tension. At 

onboarding, users select up to 3 goals to work on, and the app prompts daily mood ratings and 

recommends activities to improve mood. There are also 35 days of Guided Paths with audio 

psychoeducational lessons and activities. Mober and colleagues (2019) conducted a study with 

500 adults with mild-to-moderate anxiety or depression to evaluate the effectiveness of Sanvello. 

The study was conducted virtually with participants using the app for a month, with no level of 

use required, and compared to a waitlist group. Results showed significant improvement in 

depression, anxiety (0.47; CI 0.17 to 0.77; P=.002), stress (2.09; CI 1.09 to 3.08; P<.001)) and 

self-efficacy in the active condition, with participants who completed more thought record 

exercises experiencing sustained improvement. The study found that individuals taking 

psychiatric medication benefitted less from the app, as measured by anxiety and stress 

symptoms.   

Theoretical Justification    

Beck's cognitive theory, formulated in 1987, posits that negative cognitive patterns are 

pivotal in the etiology and maintenance of anxiety and depression. This theoretical framework 

suggests that individuals experiencing these psychological disorders often exhibit automatic 

negative thoughts leading them to perceive nonexistent threats and interpret events in a 

pessimistic manner. Such negative cognitions arise from the establishment of negative belief 

patterns or schemas, which evolve over time through the influence of past experiences (Clark et 

al., 1996).The theory postulates that modifying these negative thoughts and schemas can 

14 

 
 
effectively alleviate symptoms of anxiety and depression. This forms the fundamental premise of 

Mindfulness-Based Cognitive Therapy (MBCT), an intervention that assists individuals in 

recognizing and transforming their negative thoughts, beliefs, and behaviors. Cognitive 

restructuring, a pivotal process within MBCT, involves identifying and challenging negative 

thoughts and beliefs, subsequently substituting them with more balanced and positive cognitive 

alternatives. The interpretation and construction of meaning are inherently shaped by an 

individual's subjective and personal schemas, which are in turn molded by their experiences and 

comprehension. When these schemas significantly deviate from reality, cognitive distortions and 

emotional disorders may ensue. The repetition of distressing events reinforces the strength of 

these schemas, amplifying the activation of maladaptive schemas and heightening the likelihood 

of psychopathological symptoms (Barlow, 2002).Beliefs, encompassing assumptions, fears, and 

evaluations, also play a prominent role in the cognitive model. Core beliefs, operating at the 

deepest level, exert a profound influence on an individual's self-concept, perceptions of others, 

and their worldview. Intermediary beliefs impact an individual's interpretation of specific 

situations, whereas automatic thoughts are idiosyncratic, context-specific cognitions that arise 

spontaneously. The content and orientation of automatic thoughts, as well as processing biases, 

exhibit variability across different emotional disorders, aligning with the content specificity 

hypothesis.   

Huibers and colleagues (2021) put forth a hypothetical model aimed at addressing the 

existing criticism in current research regarding the lack of experimental designs to assess the 

causal effects of putative mechanisms on treatment outcomes. Their proposal focuses on 

evaluating common procedures used in cognitive-behavioral therapy (CBT) to determine which 

of these mechanisms directly or causally impact symptoms of anxiety and depression. Previous 

15 

 
studies have established a relationship between negative automatic thoughts and the occurrence 

of anxiety and depression, with a higher frequency of negative automatic thoughts being 

associated with greater severity of anxiety (Buchmann et al., 2018; Muris et al., 2009; Silk et al., 

2019; Niles et al., 2021). According to Huibers and colleagues (2021), cognitive restructuring is 

the proposed mechanism through which the reduction in negative automatic thoughts contributes 

to the alleviation of symptoms related to anxiety and depression.  

Cognitive Restructuring    

A potential way of decreasing negative automatic thoughts is by cognitive restructuring.  

cognitive restructuring is defined as structured, goal-directed, and collaborative intervention 

strategies that focus on the exploration, evaluation, and substitution of the maladaptive thoughts, 

appraisals, and beliefs that maintain psychological disturbance.  

  Cognitive Restructuring seek to alleviate psychological distress through altering what we think 

about as well as the way we interpret and think about our experiences or the situation we are in 

(Beck et al. 1979; Clark 1999). In cognitive restructuring, the individual must confront 

previously avoided or suppressed thoughts. The processes involved in cognitive restructuring, 

such as monitoring, stating, and challenging cognitions, serve as a form of exposure to the 

aversive material and require a willingness to experience it (Arch and Crask, 2008). Through this 

process, individuals learn to view their thoughts not as unchangeable truths, but rather as 

hypotheses to be evaluated logically and based on personal experience. Cognitive restructuring is 

seen as intervening early in the emotion generating process by altering how we interpret and 

evaluate the emotionally relevant circumstances, this perspective shares similarities with the 

concept of cognitive diffusion, as it creates a separation between the person and their thoughts, 

promoting greater awareness of present experiences (Hofmann and Asmundson, 2008).    

16 

 
 
 
          
Cognitive restructuring involves changing negative thoughts and emotions to more positive and 

productive ones(J. S. Beck & Beck, 2011).). This can be done through reappraising emotions, 

focusing on positive aspects, replacing irrational thoughts with rational ones, distraction, and 

distancing from negative thoughts (Gross, 1988; Barlow et al., 2011; Crake and Barlow 2007; 

Ellis, 1962, Fennel 1986; Beck, 1970; Amos, 2008). The process is seen in both clinical research 

and basic research and can be achieved through various techniques.    

In a study conducted by Hofmann in 2004, a total of 90 individuals with social anxiety 

were randomly assigned to three different groups: group cognitive-behavioral therapy (CBT), 

exposure therapy without cognitive restructuring, or a wait list control. The results indicated that 

both the CBT and exposure therapy groups showed comparable improvement in symptoms 

immediately after treatment. However, only the CBT group displayed sustained symptom 

improvement even after the treatment had ended. This suggests that cognitive restructuring, 

which involves identifying and modifying maladaptive beliefs, may play a critical role in 

effectively treating social anxiety disorder. Furthermore, A study investigated the effectiveness 

of cognitive restructuring in reducing pain intensity and its association with demographic 

variables in cancer patients (Jan et al., 2022). Cognitive restructuring had a significant impact on 

reducing pain in cancer patients and could help alleviate pain-related issues. It is an appropriate 

intervention to address symptoms in cancer patients, indirectly impacting their cancer treatment.  

Wolgast and colleagues (2013) examined the concept of cognitive restructuring from well- 

established measures that aim to measure cognitive restructuring. The authors utilized cognitive 

emotion regulation questionnaire (CERQ) along with emotional regulation questionnaire (ERQ) 

to create distinct factors of cognitive restructuring specifically the three that are constructive 

refocusing, cognitive reappraisal and distractive refocusing.  

17 

 
Constructive Refocusing prompts clients to perceive their emotional experience as a 

singular moment in time, urging them to adopt a broader temporal perspective when assessing 

their current emotional state. By doing so, it enables clients not only to embrace the present 

moment rather than being preoccupied with the past or future, as emphasized in mindfulness 

cognitive therapy, but also to perceive the present as a mere fragment within the larger 

continuum of their lifespan. Constructive refocusing involves redirecting one’s attention towards 

a positive active rather dwelling on the stressor. While cognitive reappraisal involves changing 

the way one think about a stressor in order to diminish the impact of the stressor. Typically, 

individuals would be asked to reframe the stressor as a challenge rather than a threat. Distractive 

refocusing involves taking one’s mind off the stressor by focusing onto unrelated activity.    

In light of Beck's cognitive theory of anxiety and depression, the present study seeks to 

delve into the potential mechanisms underlying the reduction of anxiety symptoms. While 

acknowledging the well-established link between the decrease in negative automatic thoughts 

and anxiety reduction, this research aims to go beyond this association and identify the precise 

components of cognitive restructuring that contribute to the alleviation of anxiety. By elucidating 

the specific aspects of cognitive restructuring that facilitate anxiety reduction, this investigation 

intends to enhance our understanding of the underlying processes and provide valuable insights 

for therapeutic interventions.  

In conclusion, the effectiveness of mindfulness interventions for reducing anxiety among 

individuals with anxiety disorders remains a topic of ongoing research and debate. Previous 

studies have produced mixed results, with some demonstrating positive outcomes while others 

report limited efficacy, especially when compared to cognitive-behavioral therapy. However, 

recent research has shown promising results, particularly in relation to MBSR and MBCT. 

18 

 
Moreover, dosage and frequency of mindfulness interventions appear to play a significant role in 

their effectiveness, with larger doses and longer durations generally producing more substantial 

benefits. The rise of internet and app-based mindfulness interventions has also provided a novel 

avenue for anxiety management. Several studies support the effectiveness of mobile applications 

in reducing anxiety symptoms, and comparisons with in-person interventions have shown 

promising results. Among these apps, Sanvello stands out as a commercially available app that 

incorporates cognitive restructuring, which has been shown to play a crucial role in the reduction 

of anxiety symptoms.  

Theoretical justification based on Beck's cognitive theory underscores the importance of 

cognitive restructuring in anxiety reduction. By modifying negative thoughts and beliefs, 

individuals can alleviate psychological distress and reduce anxiety. This process has shown 

promise in various studies, particularly when combined with mindfulness practices. While 

mindfulness interventions and cognitive restructuring hold great potential for anxiety reduction, 

more research is needed to understand the specific mechanisms underlying their effects. Further 

studies with larger sample sizes and more robust experimental designs are necessary to identify 

the optimal dosage and duration of mindfulness interventions and to establish their comparative 

effectiveness with other treatments. Overall, the field of mindfulness and anxiety is evolving, and 

the evidence suggests that these interventions hold promise in reducing anxiety symptoms. 

However, to fully harness their potential, continued research and refinement of these approaches 

are essential to provide individuals with effective and evidence-based strategies to manage 

anxiety and improve their overall well-being. 

19 

 
 
 
CHAPTER 3: Methodology 

Participants  

Analyses were conducted on a sample of 289 individuals enrolled in a predominately first 

year-level college course (17 to 42 years old, 59.9% female) in health-sciences at Michigan State 

University.  This sample was drawn from the 314 individuals enrolled in the course, with 25 

individuals excluded from analysis either as a result of complete in attendance in the course 

during the study period or opting out of their data being available for research use. See Fig.1 for 

CONSORT flow diagram of enrollment.  

Study Design   

Data were collected during the Spring 2023 academic semester with the pretest assessments 

collected approximately 37 days following the February 13th mass-shooting incident at Michigan 

State University which resulted in the deaths of 3 students and the injury of 5 additional students. 

For context regarding the environmental trauma/stressor, during the 3-hour incident, students 

were instructed by campus authorities to shelter in place with a directive to “run, hide, fight” as 

the assailant went building-to-building across campus (Moran et al., 2023). During this time, 

reports of potential multiple assailants were being broadcast over publicly streamed police radio 

channels and no location on campus was deemed to be a safe location. Thus, mass confusion 

ensued as police entered buildings with weapons drawn and instructed students to vacate the 

premises and flee across campus to find another location to “run, hide, fight” (Moran et al., 

2023). The experimental procedures used in this study adhered to the approved protocols of the 

Michigan State University Human Research Protection Program, ensuring compliance with 

relevant guidelines and regulations pertaining to the involvement of human subjects. 

Demographic data are provided in Table 1.  

20 

 
Primary Outcomes  

State-Trait Anxiety Inventory: Trait anxiety was assessed using the Trait scale of the 

Spielberger State-Trait Anxiety Inventory (STAI) (Spielberger et al., 1970). The questionnaire 

comprised twenty statements assessing how individuals "generally feel." The possible trait 

anxiety scores range from 20 to 80, with scores above 45 reflecting high anxiety levels 

(Kayikcioglu et al., 2017). The reliability and validity of the STAI have been well reported, with 

a Cronbach's alpha of 0.9 for reliability and a validity coefficient of 0.85 for Trait Anxiety 

(Vitasari et al., 2011). Meta-analytic findings indicate the test-retest reliability to be 0.9 for trait 

anxiety (Barnes et al., 2002).  

Perceived Stress Scale –4 Item version: Chronic stress was assessed using the Perceived 

Stress Scale-4 (PSS-4) (Cohen et al., 1983). The questionnaire consisted of four items to capture 

the frequency of stress-related thoughts and feelings experienced over the past month.  The 

possible scores range from 0 to 16, with higher scores indicating higher perceived chronic stress 

levels. The PSS-4 demonstrates sufficient internal consistency of α = .72 as a concise 4-item 

scale (Vallejo et al., 2018) and is considered as a reliable and valid instrument for assessing 

perceived chronic stress levels (Martoufzadeh et al., 2018; Lee, 2012).  

Secondary Outcomes Examined as Potential Mediators  

Emotion Regulation Questionnaire: Cognitive reappraisal was assessed using the 

Emotion Regulation Questionnaire (ERQ-10) (Gross & John, 2003). The ERQ-10 is a 10-item 

scale that measures participants' tendency to regulate their emotions (e.g., “I control my 

emotions by changing the way I think about the situation I’m in”). Items are scored on a scale 

from 1 (strongly disagree) to 4 (neutral) to 7 (strongly agree) with a higher number indicating 

better cognitive reappraisal. The construct of cognitive reappraisal thus reflects traditional 

21 

 
cognitive behavioral therapy views related to changing the appraisals of the emotion-eliciting 

stimulus or situation. Cognitive reappraisal demonstrates adequate internal consistency in all 

studied samples (Cronbach's alpha: .82–.85) (Gross & John, 2003).  

Cognitive Emotional Regulation Questionnaire: Constructive refocusing and distractive 

refocusing were assessed using the Cognitive Emotional Regulation Questionnaire (CERQ-18) 

which is designed to identify how individuals cope with adverse events through cognitive 

strategies (Garnefski & Kraaij, 2006). The construct of constructive refocusing reflects how the 

function or consequence of a situation are reframed/reinterpreted, as such this construct was 

quantified using the Refocus on Planning, Positive Reappraisal, and Putting into Perspective 

subscales of the Cognitive Emotional Regulation Questionnaire (Wolgast, Lundh, & Viborg, 

2013). These subscales included prompts following the statement “when experiencing strong 

threatening or stressful life events, how often do you think in the following manner” such as “I 

think about how to change the situation”, “I think about a plan of what I can do best”, “I think I 

can learn something from the situation”, “I think that it hasn’t been too bad compared to other 

things.”   

The construct of distractive refocusing reflects avoidance-related strategies to dissociate 

from the situation, as such this construct was quantified using the Positive Refocusing subscale 

of the Cognitive Emotional Regulation Questionnaire (Wolgast, Lundh, & Viborg, 2013). This 

subscale includes prompts following the statement “when experiencing strong threatening or 

stressful life events, how often do you think in the following manner” such as “I think of pleasant 

things that have nothing to do with it” and “I think of something nice instead of what has 

happened.” The reliability for constructive refocusing ranges from 0.82- 0.83 while distractive 

refocusing ranges from 0.73- 0.75 (Cerolini et al., 2022).  The validity for constructive 

22 

 
refocusing ranges from 0.61-0.72 with distractive refocusing ranging from 0.55-0.76 

(Dominques et al.,2023).   

Autonomic Thoughts Questionnaire: Negative automatic thoughts were assessed using 

the 8-item version of the Automatic Thoughts Questionnaire (ATQ-8) (Ruiz et al., 2020). The 

ATQ-8 employs a Likert-type scale (1 = not at all, 5 = all the time) to measure the frequency of 

negative thoughts (e.g., “I’m no good”, “I feel so helpless”) experienced during the past week, 

with higher scores indicating a higher frequency of negative automatic thoughts. The internal 

consistency across samples is adequate, with alpha and omega values of .89 (Ruiz et al., 2020).  

Process Evaluation  

Training: The course instructors received training materials, including a slide 

presentation and laboratory assignment, which described mindfulness and its benefits, and 

provided an example of a mindfulness breathing technique in all laboratory sessions. 

Additionally, the first author (OKE) and the course instructors met to discuss the weekly 

implementation of the mindfulness application in the classroom.  

Fidelity: To evaluate the extent to which the intervention was delivered as intended, 

fidelity was assessed by the process evaluator (OKE). Fidelity was assessed based on NIH 

behavior change consortium guidelines (Bellg et al., 2004; Resnick et al., 2005) for reporting 

mindfulness-based intervention trials. A checklist comprising items targeting treatment 

components from design to enactment was used at the end of the intervention. The treatment 

fidelity for this study is provided in Table 3.   

Process Evaluation Outcomes Examined as Potential Moderators  

 Implementation: The evaluation of implementation took place weekly during designated 

sessions of the course. Implementation was quantified by calculating the number of weeks in 

23 

 
 
 
 
 
                
which participants reported mindfulness practice, relative to the total four-week duration of the 

intervention.   

Dose: The intervention dose received was calculated from self-report measures. 

Participants were asked weekly to report the number of minutes they spent engaging in 

mindfulness practice during the preceding week. Each week, participants were instructed to 

select a range corresponding to their practice duration. The options were as follows: 1-29 

minutes, 30-59 minutes, 60-89 minutes, 90-119 minutes, 120-149 minutes, 150-199 minutes, and 

more than 200 minutes. To enhance reporting accuracy, participants in the MBCT group were 

provided with weekly instructions on determining the duration of their mindfulness practice 

using the Sanvello application. Dose was quantified as the mean weekly duration of mindfulness 

practice engaged in.   

Quality: To evaluate the quality of the intervention we employed an assessment 

framework encompassing acceptability, appropriateness, and feasibility. At the conclusion of the 

intervention, these dimensions were assessed using a Likert type scale, ranging from 1 

(Completely Disagree) to 5 (Completely Agree), with four items for each measure. Higher scores 

were indicative of greater acceptability, appropriateness, and feasibility of the intervention 

(Proctor et al., 2011). Despite the absence of established cut-off scores for interpretation, insight 

into qualifying participant’s perceptions of the intervention was provided through the method of 

Weiner et al. (2017) who employed an approach wherein the weighted assignments were 

collapsed into intervals (e.g., Completely disagree is reflected by scores below 20%, Disagree is 

reflected by scores from 20 to 39%, Neither agree nor disagree is reflected by scores from 40 to 

59%, Agree is reflected by scores from 60 to 79%, and Completely agree is reflected by scores 

above 79%). The Acceptability of the Intervention measure assessed how much the intervention 

24 

 
   
appealed to participants (e.g., “this intervention meets my approval”, “this intervention is 

appealing to me”, “I like the intervention”, “I welcome the intervention”). The Intervention 

Appropriateness measure evaluated the suitability of the intervention for the target population 

and environment (e.g., “this intervention is fitting”, “this intervention seems suitable”, “this 

intervention seems applicable”, “this intervention seems like a good match”). The Feasibility of 

the Intervention measure characterized the perceived ease of implementing the intervention (e.g., 

“this intervention seems implementable”, “this intervention seems possible”, “this intervention 

seems doable”, and “this intervention seems easy to use”).    

Procedure 

Using a cluster-randomized positive control design, participants engaged in a 4-week 

mindfulness intervention as a part of a predominately first year level college course in the 

aftermath of a school-shooting. Each of the sections of the course were randomly assigned to 

either the MBCT group or positive control, which ran in parallel for the duration of the study. 

The MBCT group utilized Sanvello (Sanvello Health) — a free mindfulness-based cognitive 

therapy smartphone application. Participants were encouraged to practice mindfulness daily 

through the application program "Braving Anxiety," which consisted of 35 modules. The anxiety 

management program consists of the same 5 subdomains such as 1) Watch, 2) Read, 3) Listen, 4) 

Plan, 5) Listen – Mindfulness practice.   

For example, the introductory day consisted of 1) Watch “How anxiety works”: Participants 

engaged in a brief visual presentation elucidates anxiety's intricacies. 2) Read “The anxiety loop” 

- which delves into the cyclic nature of anxiety and its impact on cognitive processes, emotions, 

and behaviors, highlighting their interdependent relationship. 3) Listen “Signs and Symptoms”- 

participants engaged in an auditory presentation that enhances their ability to identify prevalent 

25 

 
 
 
        
signs and symptoms associated with anxiety, providing a nuanced understanding of their 

potential occurrence. 4) Plan “Your anxiety goals” - through structured guidance, individuals 

were prompted to outline their anxiety goals within the designated space provided, incorporating 

the utilization of the SMART principle to optimize goal-setting efficacy. 5) Listen “Calming 

Breathing”- Participants were presented with an auditory resource guiding them through 

mindfulness practices, explicitly emphasizing the importance of integrating such techniques 

during moments of heightened anxiety.   

Participants in the positive control group were instructed to engage in the utilization of 

the Mindfulness-Based Stress Reduction (MBSR) breathing technique. Participants were 

instructed to set a timer for 5 minutes in order to engage in mindfulness breathing. 

Comprehensive instructions were provided during the initial laboratory time, elucidating the 

method by which participants were to direct their attention towards their breath. Moreover, 

participants were encouraged to passively observe their thoughts and feelings without making 

judgements or assigning value to them as anything other than brief mental events, to 

subsequently redirect their focus back to their breathing. Participants were advised to integrate 

this technique into their daily lives as a means to alleviate anxiety and stress. In the subsequent 

weeks, participants were asked to report the frequency of their mindfulness practice over the past 

week.  

All eight sections of the course (4 MBCT and 4 positive control) were provided with a 

presentation describing mindfulness and its role in health prior to receiving specific instruction 

on their assigned mindfulness practice. Prior to receiving training on mindfulness practices and 

again following the 4-week intervention period, participants completed the State-Trait Anxiety 

Inventory (Spielberger et al., 1970), the Perceived Stress Scale (Cohen et al., 1983), the Emotion 

26 

 
Regulation Questionnaire (Gross & John, 2003), the Cognitive Emotional Regulation 

Questionnaire (Garnefski & Kraaij, 2006), and the Automatic Thoughts Questionnaire (Ruiz et 

al., 2020). Intervention fidelity and quality were assessed in the MBCT group following the 4-

week intervention period.  

Statistical Analysis 

All data analyses were performed in R Version 4 (R Core Team, 2019) utilizing a 

familywise alpha level of p = 0.05. Analysis of the primary outcomes (trait anxiety and chronic 

stress) were conducted using a 2 (Group: MBCT, positive control) × 2 (Time: pre-test, posttest) 

univariate multi-level model including the random intercept for each participant to determine the 

efficacy of a 4-week MBCT (Aim 1). Additional random intercepts associated with cluster 

(course section), demographic characteristics, participant-by-mode, and participant-by-time 

interactions were considered but were not identified as statistically relevant (i.e., p < 0.05). 

Potential confounders were examined for inclusion in the multi-level modeling approach as 

additional random intercepts associated with cluster (course section), demographic 

characteristics, participant-by-mode, and participant-by-time interactions. However, as none of 

these were identified as statistically relevant (i.e., p < 0.05), they were excluded from the 

modeling approach. The multi-level model analyses were performed using the Rmimic (Pontifex, 

2022) package which provides a standardized implementation wrapper and automated post-hoc 

decompositions utilizing the lme4 (Bates et al., 2015), lmerTest (Kuznetsova et al., 2017), and 

emmeans (Lenth et al., 2017) packages in R (R Core Team, 2019) with Kenward-Roger degrees 

of freedom approximations and Benjamini-Hochberg false discovery rate control = 0.05 for post-

hoc decompositions. Cohen’s f 2 and d with 95% confidence intervals were computed as 

standardized measures of effect size, using appropriate variance corrections for within-subject 

27 

 
 
 
 
 
 
 
                      
(drm) comparisons (Lakens, 2013). Given a sample size of 289 participants and beta of 0.20 (i.e., 

80% power), the present research design theoretically had sufficient sensitivity to detect 

conventional t-test differences exceeding d = 0.16 (with a two-sided alpha) as computed using 

G*Power 3.1.2 (Faul et al., 2007).   

Analysis of secondary outcomes (constructive refocusing, distractive refocusing, cognitive 

reappraisal, and negative automatic thoughts) as potential mediators for explaining the 

relationship between the changes in primary outcomes (trait anxiety and chronic stress) as a 

function of group were conducted separately using a two-step process. First hierarchical linear 

regression analyses were performed using a forward stepwise approach based upon Akaike 

Information Criterion (Akaike, 1974) to determine if any descriptive factors (i.e., age, biological 

sex, ethnicity, socioeconomic status, and years of education) should be included in the models. 

No descriptive characteristics improved the model fit between Group and the change in Trait 

Anxiety. Age was observed to improve the model fit between Group and the change in Chronic 

Stress and was thus included as a covariate. All variables and analyses residuals were screened 

for normality and homoscedasticity using histograms, Q–Q plots, Shapiro–Wilk tests (Shapiro & 

Wilk, 1965), and Studentized Breusch-Pagan tests (Koenker, 1981), and no data transformations 

were required or applied. Next, mediation analyses were performed using the Rmimic (Pontifex, 

2022) package which provides a standardized implementation wrapper around the mediation 

(version 4.4.7; Tingley et al., 2014) package in R with unstandardized indirect effects computed 

using 1,000 nonparametric bootstrapped samples.  

Analysis of intervention process evaluation outcomes (Implementation, Dose, Quality 

[acceptability, appropriateness, and feasibility]) as potential moderators for explaining the 

change in primary outcomes (trait anxiety and chronic stress) in response to the MBCT 

28 

 
intervention were conducted using correlation coefficients. This analysis was repeated, 

examining Implementation and Dose as intervention process evaluation outcomes as potential 

moderators for explaining the change in primary outcomes (trait anxiety and chronic stress) in 

response to the positive control intervention. Analyses were performed using the Rmimic 

(Pontifex, 2022) package which provides a standardized implementation wrapper around the 

WRS2 (Mair, Wilcox, & Patil, 2022) package in R to obtain bivariate robust 20.0%-bend 

correlation coefficients. This approach provides better estimates of the true association between 

variables by downweighting the potential impacts of pseudo-outliers and highly influential 

individual data points (Pernet, Wilcox, & Rousselet, 2013).  

29 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
CHAPTER 4: Results 

Although there were no significant differences between the MBCT group and the positive 

control group with regard to socioeconomic status, p = 0.15; the MBCT group was observed to 

be slightly older (19.9 ± 2.4 years) and have more education (13.9 ± 1.0 years) than the positive 

control group (age: 19.4 ± 1.6; education: 13.4 ± 0.8), Mann–Whitney U’s ≥ 6963.0, Z’s ≥ 4.9, 

p’s < 0.001, r’s = 0.29. Demographic data are provided in Table 1.  

Primary outcomes examining the efficacy of a 4-week MBCT intervention, relative to a positive 

control group  

Trait Anxiety: Analysis revealed a main effect of Time, F(1, 251.6) = 13.2, p < 0.001, f 2 

= 0.59 [95% CI: 0.40 to 0.85], which was superseded by a Group × Time interaction, F(1, 251.6) 

= 7.2, p = 0.008, f 2 = 0.32 [95% CI: 0.19 to 0.49]. Post-hoc decomposition of the Group × Time 

interaction was conducted by examining the effect of Time within each Group. For the MBCT 

group, the difference between posttest (45.5 ± 5.1) and pretest (47.4 ± 4.5) was statistically 

significant; t(242) = 4.7, p < 0.001, drm = 0.39 [95% CI: 0.23 to 0.56]. However, no significant 

differences were observed between pretest (47.1 ± 4.5) and posttest (46.9 ± 4.6); t(259) = 0.6, p 

= 0.52, drm = 0.06 [95% CI: -0.12 to 0.24] for the positive control group. Secondary post-hoc 

decomposition of the Group × Time interaction was conducted by examining the effect of Group 

within each Time. At pretest, no significant differences were observed between the positive 

control group and the MBCT group; t(413) = 0.3, p = 0.7, ds = 0.04 [95% CI: -0.19 to 0.27]. At 

posttest, the difference between the positive control group and the MBCT group was statistically 

significant; t(453) = 2.2, p = 0.025, ds = 0.29 [95% CI: 0.04 to 0.55]. See Figure 2a.  

Chronic Stress: Analysis revealed a main effect of Time, F(1, 243.4) = 38.3, p < 0.001, f 2 

= 0.77 [95% CI: 0.54 to 1.09] ,which was superseded by a Group × Time interaction, F(1, 243.4) 

30 

 
= 9.2, p = 0.003, f 2 = 0.19 [95% CI: 0.09 to 0.30]. Post-hoc decomposition of the Group × Time 

interaction was conducted by examining the effect of Time within each Group. For the MBCT 

group, the difference between pretest (8.6 ± 2.6) and posttest (7.5 ± 2.4) was statistically 

significant; t(236) = 6.9, p < 0.001, drm = 0.47 [95% CI: 0.33 to 0.61]. The positive control group 

also exhibited a statistically significant, albeit smaller, difference between pretest (8.6 ± 2.7) and 

posttest (8.2 ± 3.0); t(248) = 2.1, p = 0.036, drm = 0.15 [95% CI: 0.01 to 0.29]. Secondary post-

hoc decomposition of the Group × Time interaction was conducted by examining the effect of 

Group within each Time. At pretest, no significant differences were observed between the 

positive control group and the MBCT group; t(365) = 0.1, p = 0.9, ds = 0.01 [95% CI: -0.22 to 

0.24]. At posttest, the difference between the positive control group and the MBCT group was 

statistically significant; t(405) = 2.3, p = 0.022, ds = 0.30 [95% CI: 0.04 to 0.55]. See Figure 2b.  

Secondary outcomes examined as potential mediators of the anxiolytic and stress-reducing 

effects of the mindfulness-based cognitive therapy intervention 

Trait Anxiety and Cognitive Reappraisal: Analysis observed that the relationship between 

Group (the positive control group vs the MBCT group) and changes in trait anxiety was not 

mediated by changes in cognitive reappraisal; Proportion Mediated = -2.9% [95% CI: -19.3% to 

6.8%]; Average Causal Mediation Effect = 0.04 [95% CI: -0.05 to 0.15], p = 0.46; Average 

Direct Effect = -1.26 [95% CI: -2.21 to -0.33], p = 0.006.  

Trait Anxiety and Constructive Refocusing: Analysis observed that changes in 

constructive refocusing accounted for -12.9% [95% CI: -49.1% to -0.6%] of the relationship 

between Group and changes in trait anxiety; Average Causal Mediation Effect = 0.16 [95% CI: 

0.01 to 0.35], p = 0.032; Average Direct Effect = -1.39 [95% CI: -2.29 to -0.52], p < 0.001). The 

directionality of the effects suggests that suppression may be occurring rather than mediation, 

31 

 
such that including changes in constructive refocusing within the model appears to increase the 

strength of the relationship between Group and changes in trait anxiety rather than eliminate it.  

Trait Anxiety and Distractive Refocusing: Analysis observed that the relationship 

between Group and changes in trait anxiety was not mediated by changes in distractive 

refocusing; Proportion Mediated = -1.8% [95% CI: -17.4% to 12.6%]; Average Causal 

Mediation Effect = 0.02 [95% CI: -0.11 to 0.15], p = 0.7; Average Direct Effect = -1.25 [95% CI: 

-2.16 to -0.34], p = 0.006.  

Trait Anxiety and Negative Automatic Thoughts: Analysis observed that changes in 

negative automatic thoughts accounted for 28.0% [95% CI: 4% to 121.2%] of the relationship 

between Group and changes in trait anxiety; Average Causal Mediation Effect = -0.39 [95% CI: -

0.89 to -0.07], p = 0.01; Average Direct Effect = -0.99 [95% CI: -2.07 to 0.12], p = 0.092 (see 

figure 3.iv.a).  

Chronic Stress and Cognitive Reappraisal: Analysis observed that the relationship 

between Group and changes in chronic stress was not mediated by changes in cognitive 

reappraisal; Proportion Mediated = 8.7% [95% CI: -5.0% to 29.7%]; Average Causal Mediation 

Effect = -0.06 [95% CI: -0.17 to 0.03], p = 0.21; Average Direct Effect = -0.58 [95% CI: -1.00 to 

-0.21], p = 0.002), after controlling for the effects of Age.  

Chronic Stress and Constructive Refocusing: Analysis observed that the relationship 

between Group and changes in chronic stress was not mediated by changes in constructive 

refocusing; Proportion Mediated = 7.7% [95% CI: -2.0% to 32.6%]; Average Causal Mediation 

Effect = -0.05 [95% CI: -0.16 to 0.01], p = 0.16; Average Direct Effect = -0.59 [95% CI: -1.01 to 

-0.17], p = 0.01), after controlling for the effects of Age.  

32 

 
Chronic Stress and Distractive Refocusing: Analysis observed that the relationship 

between Group and changes in chronic stress was not mediated by changes in distractive 

refocusing; Proportion Mediated = 9.5% [95% CI: -1.3% to 35.3%]; Average Causal Mediation 

Effect = -0.06 [95% CI: -0.15 to 0.00], p = 0.072; Average Direct Effect = -0.58 [95% CI: -1.00 

to -0.16], p = 0.014), after controlling for the effects of Age.  

Chronic Stress and Negative Automatic Thoughts: Analysis observed that changes in 

negative automatic thoughts accounted for 44.9% [95% CI: 18.0% to 133.1%] of the relationship 

between Group and changes in chronic stress; Average Causal Mediation Effect = -0.31 [95% 

CI: -0.53 to -0.12], p < 0.001; Average Direct Effect = -0.38 [95% CI: -0.86 to 0.09], p = 0.12), 

after controlling for the effects of Age (see figure 3.iv.b).  

Process evaluation outcomes examined as potential moderators of the anxiolytic and stress-

reducing effects of the MBCT intervention 

Fidelity: This investigation ensured robustness in research design by grounding our 

intervention in the cognitive theory of anxiety and depression. Transparent communication was 

maintained among investigators, facilitators, and the first author. Facilitators were formally 

trained and received feedback to refine their delivery techniques. Participant engagement was 

monitored weekly through Qualtrics surveys and program quality was assessed from participant 

perspectives. Additionally, data on participants' daily mindfulness practices was collected to 

provide insight into the practical application of treatment-related skills. This allowed for 

assessment of engagement and practical use of learned techniques.  

Implementation: The MBCT group exhibited greater implementation (79.2 ± 25.0 %) 

relative to the positive control group (64.3 ± 28.3 %), t(287) = 4.8, p < 0.001, ds = 0.56 [95% CI: 

0.33 to 0.80].  

33 

 
Dose: The MBCT group exhibited a higher dose (20.5 ± 24.5 minutes) of the intervention 

than the positive control group (12.8 ± 15.9 minutes), t(257.6) = 3.2, p = 0.002, ds = 0.38 [95% 

CI: 0.14 to 0.61].  

Quality: Perceptions of the acceptability of the intervention were skewed positively with 

21.3% of the MBCT group completely agreeing and 70% of the MBCT group agreeing. Only 

7.3% of the MBCT group was ambivalent and 1.3% completely disagreed with the acceptability 

of the intervention. Perceptions of the appropriateness of the intervention and the feasibility of 

the intervention indicated that 78.7% of the MBCT group completely agreeing and 20.7% 

agreeing. Only 0.7% of the MBCT group was ambivalent regarding the appropriateness and 

feasibility of the intervention.   

Trait Anxiety: Correlational analysis of the change in trait anxiety with process evaluation 

outcomes in the MBCT group revealed a weak positive relationship for both intervention 

appropriateness, r = 0.21 [95% CI: 0.06 to 0.37], p = 0.009, and intervention feasibility, r = 0.20 

[95% CI: 0.03 to 0.34], p = 0.017; such that greater evaluation of appropriateness and feasibility 

of the MBCT intervention was associated with smaller reductions in trait anxiety. Correlational 

analysis of the change in trait anxiety with process evaluation outcomes in the positive control 

group revealed no significant relationships (|r’s| < .019, p’s > 0.8). See Table 2.  

Chronic Stress: Correlational analysis of the change in chronic stress with process 

evaluation outcomes in the MBCT group revealed no significant relationships (|r’s| < .06, p’s > 

0.4). Correlational analysis of the change in chronic stress with process evaluation outcomes in 

the positive control group revealed a weak positive relationship for dose, r = 0.24 [95% CI: 0.08 

to 0.39], p = 0.005, such that greater weekly duration was associated with smaller reductions in 

chronic stress. See Table 2.  

34 

 
CHAPTER 5: Discussion  

The primary aim of the present investigation was to determine the efficacy of a 4-week 

MBCT intervention delivered through the Sanvello smartphone application for reducing trait-

level anxiety and chronic stress within the context of an entry-level collegiate course. To answer 

this question, trait anxiety and chronic stress were assessed prior to and following a 4-week 

intervention period where students were instructed to use either the Sanvello smartphone 

application or a MBSR-based breathing technique as a part of the course following a mass-

shooting incident using a cluster-randomized approach. Results from the present investigation 

replicate the extant literature on MBCT-based interventions for reducing anxiety and in-

particular, the findings by Moberg and colleagues (2019) who similarly assessed the effects of 

the Sanvello platform over the course of a 30-day intervention. Specifically, replicating Moberg 

et al.’s (2019) finding (cohen’s d = 0.4), the present investigation observed small to moderate 

reductions in trait anxiety (cohen’s drm = 0.39 [95% CI: 0.23 to 0.56]) from pre- to posttest in 

individuals randomized to the MBCT-based group that used the Sanvello platform for a 4-week 

period. Thus, despite utilizing a more generalized sample of students enrolled in a predominately 

first year level college course, who may not necessarily have been motivated a priori to seek out 

MBCT-based therapy; the relative consistency of the findings is promising and is in-line with 

similar effect sizes observed in response to in-person mindfulness-based intervention programs 

(in-person standard MBCT approaches on reducing trait-level anxiety (hedges g = 0.466) 

(Bamber and Morpeth, 2019).  

The present investigation also replicated Moberg et al.’s (2019) finding of reductions in 

chronic stress (cohen’s d = 0.46). Specifically, following the 4-week intervention period 

individuals randomized to the MBCT-based group that used the Sanvello platform exhibited 

35 

 
moderate reductions in perceptions of chronic stress (cohen’s drm = 0.47 [95% CI: 0.33 to 0.61]) 

from pre- to posttest. Although, such a moderate effect size is somewhat smaller than meta-

analytic findings from traditional mindfulness-based interventions (hedges g = 0.83 [95% CI: 

0.58 to 1.08]) (Khoury, Sharma, Rush, Fournier, 2015); it is important to note that the end of the 

4-week intervention period in the present investigation coincided with the end of the academic 

term. Thus, it may be that the stress-reducing effects of the intervention were suppressed to some 

extent due to final exams.  

From a programmatic perspective, it may also be that the smaller effect sizes for stress 

reduction resulting from the Sanvello platform — in comparison to traditional mindfulness-based 

interventions — were the result of the particular modules within the application that participants 

were instructed to complete. Within the present investigation, participants were asked to utilize 

the 35 modules associated with the application program "Braving Anxiety;" as such the specific 

content within the modules was oriented to target anxiety rather than chronic stress which may 

account for the relatively smaller effect sizes for the stress-reducing effects of the application. 

Further, of particular interest is that the positive control group also appear to have incurred 

reductions in chronic stress over the 4-week intervention (cohen’s drm = 0.15 [95% CI: 0.01 to 

0.29]). While the positive control group did not engage in mindfulness-based stress reduction per 

se, the basic training provided to this group did employ a classic MBSR breathing technique and 

associated prompt. However, unlike the Sanvello smartphone application which provided 

recurring feedback and guidance; individuals in the positive control group did not receive 

repeated instruction over the course of the intervention period beyond encouragement to continue 

to practice the breathing technique and mindset. Nevertheless, it appears that even this approach 

was effective in incurring some small reductions in chronic stress.  

36 

 
It is also important to highlight the observation that the Sanvello smartphone application 

was associated with anxiolytic and stress reducing effects despite only 20.5 (± 24.5) minutes of 

use per week. Accordingly, as two-hour in-person mindfulness-based intervention programs with 

experienced, certified mindfulness instructors appear to exhibit similar reductions in trait anxiety 

(Bamber and Morpeth, 2019) and only slightly more pronounced effects for chronic stress 

(Khoury, Sharma, Rush, Fournier, 2015); it would appear that the Sanvello smartphone 

application provides an alternative and accessible intervention that can more easily be deployed 

across a broader population and implemented into existing curricular and student-support 

programming. Such an approach may be well-positioned to reduce high levels of trait anxiety 

and chronic stress among collegiate students, while freeing up both time and resources for 

clinical practitioners to focus on those students with more dire/urgent needs.  

Mechanisms 

The secondary aim of the present study was to investigate cognitive restructuring 

domains (cognitive reappraisal, constructive refocusing, and distractive refocusing) and negative 

automatic thoughts as potential causal mechanisms responsible for the anxiolytic and stress 

reducing effects of the MBCT intervention. To answer this question, these constructs were 

assessed before and after the 4-week intervention period; the change in these constructs was 

examined as potential mediators of the relationship between the changes in trait anxiety and 

chronic stress as a function of the interventional groups (MBCT vs positive control). Despite the 

hypothesized causal pathway whereby MBCT interventions incur reductions in mental-health 

outcomes such as trait anxiety and chronic stress through alterations in cognitive reappraisal, 

constructive refocusing, and distractive refocusing, findings from the present investigation failed 

to observe a mediating effect of these constructs on either trait anxiety or chronic stress.    

37 

 
      
Despite such findings, it is important to highlight that this does not necessarily mean that 

cognitive reappraisal, constructive refocusing, and distractive refocusing are irrelevant in the 

context of mindfulness-based interventions inducing anxiolytic and stress-reducing effects. 

Rather, such a finding may be the result of the Sanvello application’s primary emphasis on 

addressing negative automatic thoughts. While it does incorporate elements of cognitive 

restructuring, the consistency and intensity with which these are applied appear to be lesser than 

its focus on negative automatic thoughts. This design choice might explain why, despite our 

initial hypothesis that the Sanvello app would promote mental well-being through modifications 

in cognitive reappraisal, constructive refocusing, and distractive refocusing, our findings did not 

support this. Although considering changes in constructive refocusing as a covariate in the 

analysis served to increase the relationship between Group and changes in trait anxiety, the 

mediation analysis observed that constructive refocusing does not appear to be a mediator as it 

does not account for the effects of the intervention on changes in trait anxiety. Accordingly, 

these findings align with that of Foa and colleagues (2005), who observed that cognitive 

restructuring had limited effects on individuals with PTSD and their perceived levels of chronic 

stress. However, consistent with other investigations, negative automatic thoughts were found to 

account for nearly 28% of the effect of the intervention on trait anxiety and 45% of the effect of 

the intervention on chronic stress. Indeed, in their systematic review and meta-analysis, Gu and 

colleagues (2015) identified negative automatic thoughts as a mediator of the effects of MBCT 

interventions on depression, anxiety, and stress — yet cautioned their finding as the extant body 

of evidence lacked active control groups and failed to consider changes in the outcome. 

Accordingly, the present investigation addresses such limitations to provide further support for 

tailoring MBCT interventions to specifically target negative automatic thoughts to enhance their 

38 

 
potential anxiolytic and stress-reducing effects. 

Process Evaluation 

The final aim of the present study was to determine the extent to which the anxiolytic and 

stress-reducing effects of the MBCT intervention delivered through the Sanvello platform were 

moderated by intervention fidelity domains (implementation dose, quality). To answer this 

question, analyses were conducted examining the relationship between intervention fidelity 

domains and the changes in trait anxiety and chronic stress within each interventional group. 

Findings from the present investigation observed no association between the dose or 

implementation of the MBCT-intervention and the change in trait anxiety. It is important to note 

that the present investigation relied upon self-reported measures of dose and implementation that 

were assessed on a weekly basis. Thus, the lack of an association may reflect inaccuracy within 

the self-report construct. Although such findings stand in contrast to meta-analytic findings by 

Parson et al. (2017), who observed a small yet positive relationship (r = 0.26) between 

mindfulness dose and intervention outcomes in randomized controlled trials (n=28). It's crucial 

to emphasize that the duration of our intervention might have limited the variability in 

intervention dosage and implementation, potentially leading to our null findings. Reliance on 

self-reported measures of usage can introduce biases, and using broad categorizations for dosage 

can mask nuanced differences.   

Furthermore, potential clarification of our null findings is provided by Bamber and 

Morpeth (2019) who conducted a meta-analysis on college-aged samples. They sought to discern 

a relationship between mindfulness practice duration and its effect on anxiety. It was 

hypothesized that such a finding may be the result of the particular time constraints that college 

students experience; whereby spending greater time in mindfulness practice may exacerbate 

39 

 
 
  
 
 
            
perceptions of stress and anxiety as students are not working on other tasks (e.g., papers, 

projects, studying) (Bamber & Morpeth, 2019). Such an interpretation may also serve to explain 

why the positive control intervention observed that spending greater time on the MBSR-based 

breathing technique was associated with smaller reductions in chronic perceptions of stress. 

However, Bamber and Morpeth (2019) also observed that completing a greater number of total 

mindfulness sessions — regardless of the duration of the mindfulness session — was associated 

with a greater anxiolytic effect.  

Future scholarly endeavors are requisite to delve into the relationship between the 

frequency of Sanvello platform usage and its potential efficacy in mitigating trait anxiety and 

chronic stress among collegiate populations, irrespective of the cumulative duration of the 

engagement. Simultaneously, the robustness and validity of findings would be greatly enhanced 

by adopting methodologies that extend beyond self-reported measures. Moreover, the brief 

duration of our current intervention could have led to a lack of variance in both the intervention 

dose and its implementation, which might explain a portion of the observed null findings. A 

critical area for subsequent research would be to evaluate the efficacy of the Sanvello 

smartphone application when used over a more extended period, such as an 8-to-16-week 

timeframe (with 16 weeks mirroring a typical collegiate semester). This extended engagement 

would provide a comparative perspective against our study's concise intervention duration and 

the traditional 8-week face-to-face intervention methodology.  

In regard to intervention quality, the present investigation specifically characterized 

participant’s perceptions of the intervention acceptability, appropriateness, and feasibility; and 

examined these factors as potential moderators of the anxiolytic and stress reducing effects of 

using the Sanvello smartphone application. Participants using the Sanvello smartphone 

40 

 
application overwhelmingly considered it to be an appropriate (suitable for the target population 

and environment) and feasible (perceived ease of use) intervention. Specifically, within the 

present investigation over 75% of participants rated the appropriateness and feasibility of the 

intervention above 80% (i.e., completely agree that the Sanvello smartphone application was 

suitable for the target population and environment and easy to use) and only a single participant 

rated the appropriateness and feasibility of the intervention below 60%. Perceptions of the 

intervention acceptability, were somewhat lower with 70% of participants rating the intervention 

between 60% and 80% acceptable (i.e., agree that the Sanvello smartphone application was 

appealing to use); and only 9% of participants rating the acceptability of the intervention below 

60%.  

 Nevertheless, participant perceptions of the acceptability, appropriateness, and feasibility 

of using the Sanvello smartphone application were not found to be associated with the changes in 

chronic perceptions of stress. Interestingly, the more positively participants rated the 

appropriateness and feasibility of using the Sanvello smartphone application the smaller the 

reduction in trait anxiety (r ~ 0.2).  Speculatively, such a finding may be the result of participants 

more drawn to using the Sanvello smartphone application progressing further with MBCT-based 

treatment. The extant literature surrounding standard cognitive behavioral therapies indicates that 

individuals experience a gradual diminishment of negative automatic thoughts over the course of 

prolonged treatment, but that these thoughts exhibit a cyclic pattern of dissipation and re-

emergence (Castonguay et al., 2010).  As such, the efficacy of the intervention may be observed 

to follow such a similar pattern with individuals earlier in the treatment exhibiting more 

pronounced effects than those in later stages of treatment. Given the self-paced nature of the 

Sanvello smartphone application with distinct modules for completion, further insight may be 

41 

 
provided by future investigations specifically characterizing this pattern over the course of 

module completion. Some caution is warranted in the present finding, however, given the 

relatively small relationship and minimal variation in participant responding that could have 

contributed to spurious findings despite using a robust correlation approach. These findings stand 

in contrast to previous research which has observed an influence of participants' perception of 

treatment plausibility and expectancy of positive outcomes, indicating a small but significant 

impact on treatment outcomes in psychological therapies more broadly (Constantino et al., 

2011). Nevertheless, the extent of such effects within the context of mindfulness-based 

interventions remains somewhat inconclusive (Crane et al., 2014; Snippe et al., 2015). 

Ultimately, the present findings highlight that participants in a predominately first year level 

collegiate course generally had high perceptions of the acceptability, appropriateness, and 

feasibility of utilizing the Sanvello smartphone application; even if such metrics of intervention 

quality did not translate to greater intervention efficacy.  

Consistent with aims to improve reporting of mindfulness-based practices, the present 

investigation also qualified the mindfulness intervention used within the present investigation 

using the Mindfulness-Based Interventions, a fidelity tool developed by Bellg et al. (2004) and 

validated by Resnick et al. (2005). This fidelity tool consists of a comprehensive checklist, 

designed to ensure transparency and accuracy in evaluating the components of fidelity. The 

checklist encompasses various aspects, including the intervention's design and the training 

provided to instructors, which was conducted by the first author (OKE). With regard to the 

intervention design, the present investigation was largely consistent with the extant literature in 

detailing the treatment fidelity component of the study design (Ketcher et al., 2019). However, a 

strength of the present investigation was specifically considering a construct framework 

42 

 
perspective for assessing potential underlying mechanisms of the intervention efficacy. The use 

of the Sanvello smartphone application resulted in qualitatively different training than that 

employed by typical interventions that require extensive instructor training and recording to 

effectively deliver the intervention as intended. As such the instructor training was largely 

centered around application use; as the application has a user-centric interface and given the 

strong perceptions of usability from participants, it would appear that minimal training is 

necessary to ensure consistent mindfulness practice using this application. In regard to 

intervention delivery, the present investigation employed methods that are similar to the extant 

literature with active control groups ensuring equivalent feedback to both groups (Cherkin et al., 

2016; Hoge et al., 2013; Shallcross et al., 2015; Williams et al., 2014; Kristeller et al., 2013). A 

benefit of the present design was the incorporation of the mindfulness-based intervention within 

the context of existing curricular programming. As such, the implementation of the intervention 

was particularly strong. Given the self-paced nature of the Sanvello smartphone application, the 

enactment of the intervention was characterized by the mean weekly duration of usage which is 

consistent with the extant literature reporting minutes per week of in-person or at home practice 

of mindfulness (Geschwind et al., 2012). Accordingly, the fidelity assessment suggests that 

interventional approach is consistent with that of the extant literature in this area and replicable 

for future investigations in this area.   

Limitations 

 Despite the relative strength of the present investigation, utilizing a large sample in a 

cluster-randomized design with a positive control group; it is important to highlight a number of 

limitations that represent deliberate choices and future directions. In particular, the present 

investigation restricted the study sample to only students enrolled in a single predominately 

43 

 
 
 
 
 
                    
 
 
freshman-level college course. Although predominantly first year college-students have been 

found to exhibit higher levels of trait anxiety than their older and non-college aged peers 

(Naceanceno et al, 2021); further research is necessary to better understand the extent to which 

the feasibility and efficacy of using the Sanvello smartphone application may be altered with an 

older or more diverse sample of collegiate students. It is also important to acknowledge that the 

sample characteristics of the present investigation pertain to a specific population of college 

students who had experienced heightened anxiety and stress following the school shooting 

incident, potentially influencing our study outcomes but nevertheless reflecting a growing 

segment of school-aged children within the US. Additionally, as the cluster randomization 

approach assigned the intervention to students based upon their course enrollment (by section); it 

may be that pre-existing differences in sensitivity to mindfulness-based interventions or pre-

exposure to mindfulness practices may have also related to course section enrollment. Although 

no differences between groups were observed for either trait anxiety or chronic stress at pretest, 

further research is necessary utilizing full randomization of participants to better account for this 

possibility.  

 While the present investigation did not include a follow-up assessment due to the end of 

the semester, it is worth noting that Morber and colleagues (2018), who utilized the same 

application, demonstrated that the treatment benefits were sustained for a period of two months 

following the conclusion of the one-month intervention. Accordingly, future studies may benefit 

by characterizing the longer-term effects of utilizing the Sanvello smartphone application. In 

particular, the nature of the application makes it such that individuals could presumably continue 

to use it well after formal training and monitoring of the intervention is completed with minimal 

additional burden. In this way, better metrics of the acceptability, appropriateness, and feasibility 

44 

 
of using the application could be assessed by examining the extent to which participants choose 

to continue to use the application when no longer explicitly assigned to do so.  Furthermore, 

future studies could benefit from conducting longer follow-up assessments beyond the typical 

two-month period. Evaluating the sustained efficacy of brief MBCT interventions over extended 

timeframes will provide critical insights into the long-term impact and durability of these 

interventions. To bridge the gap between efficacy and effectiveness, it is paramount for research 

to explore the real-world implications of interventions, like the Sanvello app, in varied settings 

and across diverse populations. Doing so will not only refine our understanding of anxiety and 

stress interventions but also pave the way for more targeted and effective strategies for 

promoting mental well-being.  

Collectively, the present investigation provides evidence that utilizing the Sanvello 

smartphone application within the context of existing curricular programming targeted towards 

predominately first year college students can be an effective means of reducing high levels of 

trait anxiety and chronic stress in this population. The cost-free platform and wide device 

compatibility of the Sanvello smartphone application renders it as a highly accessible alternative 

to traditional in-person MBCT-intervention approaches, enabling students to engage in 

mindfulness-practice when it best fits their needs and schedules while at the same time reducing 

potential burden on existing clinical services. Such findings are particularly relevant given 

evidence that many college counseling centers across the US are under-resourced and operate at 

total capacity during much of the year (Bailey et al., 2020). Although the Sanvello smartphone 

application was only perceived as moderately appealing to use — perhaps as a result of 

integrating it within the context of existing curricular programming; students overwhelmingly 

considered it to be an appropriate (suitable for the target population and environment) and 

45 

 
feasible (perceived ease of use) intervention. As such, the present findings suggest that student 

support initiatives to enhance mental health and well-being may be well served by adopting such 

a platform within the context of first-line treatment and prevention of anxiety and stress within 

first year college students. Further, by considering potential mechanisms which may underlie the 

efficacy of MBCT-based interventions; the present investigation highlighted the critical 

importance of interventions targeting negative automatic thoughts for optimizing their anxiolytic 

and stress-reducing effects. Student support initiatives seeking to enhance mental health and 

well-being through diverse programming should prioritize interventions that address negative 

automatic thoughts, as they play a key role in influencing both anxiety and stress outcomes. 

Overall, these findings provide valuable insights into the efficacy of utilizing the Sanvello 

smartphone application, potential mechanistic processes responsible for the efficacy, and insight 

into the relationship between intervention efficacy and fidelity. Such findings emphasize the 

importance of considering participants' perceptions and experiences in intervention design and 

implementation, even if they may not relate to greater intervention efficacy.  

46 

 
  
  
  
 
 
 
 
 
 
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APPENDIX A: IRB Approval Letter 

54 

 
55 

 
 
56 

 
 
57 

 
 
 
 
58 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
59 

 
 
 
 
APPENDIX B: Dissertation Funding Source  

Dissertation Funding Source  

1.Dissertation Completion Fellowship- 2022/2023  

The Graduate School, Michigan State University,  

Funded- $7,000  

Use: Teaching release to allow time for analysis, writing, and defense preparation 

60 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Table 1.  Participants demographic characteristics (mean ± SD)  

  Measure   

N   

Race  

MBCT  

Positive Control  

150 (95 females)  

139 (78 females)  

20% nonwhite  

16.5% nonwhite  

   American Indian or Alaska Native  

   Asian  

   Black or African American  

   Native Hawaiian or other Pacific Islander  

   Hispanic or Latinx  

   White or Caucasian  

   Multiracial  

Age (years)  

Education (years)  

1  

6  

7  

0  

3  

120  

13  

0  

6  

5  

1  

4  

116  

7  

19.4 ± 1.6  

13.9 ± 1.0  

19.9 ± 2.4  

13.4 ± 0.8  

Socioeconomic status   

69.0 ± 15.5  

66.6 ± 16.4  

Implementation (% of weeks)  

79.2 ± 25.0  

64.3 ± 28.3  

Dose (minutes)  

20.5 ± 24.5  

12.8 ± 15.9  

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Table 2. Bivariate robust 20.0%-bend correlation matrix for process evaluation outcomes 

(implementation, Dose, Quality [acceptability, appropriateness, and feasibility]) as potential 

moderators for explaining the change in primary outcomes (trait anxiety and chronic stress) 

Trait 

Chronic 

Anxiety  

Stress  

Implementation   Dose   Acceptability   Appropriateness  

MBCT Intervention  

   Trait Anxiety  

---  

   Chronic Stress  

.130  

---  

   Implementation  

-.042  

.052  

Dose  

.152  

.015  

---  

.020  

---  

   Acceptability  

.122  

.067  

-.289***  

.122  

---  

   Appropriateness  

.213**  

-.048  

-.210*  

.200  

.567***  

---  

Feasibility  

.195*  

-.046  

-.213**  

.033  

.507***  

.772***  

Positive Control Intervention  

   Trait Anxiety  

---  

   Chronic Stress  

.002  

---  

   Implementation  

-.012  

.092  

---  

Dose  

.019  

.239*  

.287***  

---  

Note: * indicates p < 0.05. ** indicates p < 0.01. *** indicates p < 0.001.  

62 

 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
 
 
 
 
 
Table 3. Treatment Fidelity Tool for Mindfulness Based Interventions 

Item Checklist 

Author Comments 

  Theoretical/substantive rationale for 
any adaptations from established 
MBI  

  MBI and comparison program 

matched for dosage within and across 
conditions (e.g., number of sessions, 
hours per session, number of weeks, 
days per week) 

  Plan for implementation setbacks 

(e.g., back-up facilitators) 

1. Cognitive theory of anxiety and 
depression was utilized for theoretical 
rational of the study  
2. The positive control group met the same 
number of times compared to MBCT  

3. The execution of the study encountered 
obstacles arising from a tragic occurrence of 
a school shooting, which necessitated a 
strategic shift in order to mitigate the 
duration of the intervention. 

  All facilitators received formal 

4. All facilitators met with the first author  

training.  

  All facilitators were observed and 
received constructive feedback 
during initial phases  

  All facilitators received ongoing, 

real-time constructive feedback, and 
inter-rater reliability assessments to 
minimize drift from curriculum and 
contamination between intervention 
groups 

  Participant attendance recorded.  

  Measure of program acceptability 

collected. 

5. Facilitators were given feedback regularly 

6. Throughout the duration of the semester, 
the primary author and facilitators 
maintained a continuous and unhindered 
channel of communication in order to 
ensure seamless operationality. 

7. Attendance data was collected by means 
of a weekly Qualtrics survey. 
8. Measure of program acceptability, 
feasibility, and acceptances was gathered at 
the end of the program both from 
participants and facilitators  

  Measure of practice collected (e.g., 
daily practice logs for minutes and 
types of practice used) 

9. On a weekly basis, participants were 
requested to provide information regarding 
the total duration, measured in minutes, of 
their engagement for mindfulness  

Fidelity 
Component 

Design: ensure a 
study can 
adequately test its 
hypotheses in 
relation to 
underlying theory 
and clinical 
processes 

Training: ensure 
treatment 
providers are 
satisfactorily 
trained to deliver 
the intervention 

Delivery: ensure 
intervention is 
delivered as 
intended 

Receipt: monitor 
and improve 
ability of 
participants to 
understand and 
perform 
treatment-related 
skills and 
strategies during 
delivery 

Enactment: 
monitor and 
improve the 
ability of 
participants to 
perform 
treatment-related 
skills and 
strategies in real-
life settings 

63 

 
 
 
 
  
 
 
 
 
 
 
 
 
 
Figure 1. CONSORT flowchart of the intervention 

64 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
Figure 2. Primary Outcomes - Mean (± SE) trait anxiety (a) and chronic stress (b) at pre and 

posttest for the MBCT (solid green lines) and positive control (dashed blue lines) groups 

65 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Figure 3. Scatterplots showing the relationship between changes in trait anxiety (a) and chronic 

stress (b) (posttest – pretest) and changes in secondary outcomes that were considered as 

mediators, for the MBCT (solid green circles/lines) and positive control (solid blue 

triangles/dashed blue lines) groups. Note: a small amount of random jitter was introduced for all 

scatterplots graphically representing the data to present overplotting 

66 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Figure 4. Scatterplots showing the relationship between changes in trait anxiety (a) and chronic 

stress (b) (posttest – pretest) and process evaluation outcomes examined as potential moderators, 

for the MBCT (solid green circles/lines) and positive control (solid blue triangles/dashed blue 

lines) groups. Note: a small amount of random jitter was introduced for all scatterplots 

graphically representing the data to present overplotting 

67 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
Figure 4. (cont’d) 

68