Cluster-randomized Controlled Trial Examining the Effectiveness of Mindfulness-Based Cognitive Therapy for Anxiety and Stress Reduction Within College Students
Phase: NA
Conditions: Anxiety, Stress
Sponsor: Michigan State University

NCT# 
 
1 
 
 
 
Study Protocol and Statistical Analysis Plan 
For Research Project: 
 
“Cluster-randomized Controlled Trial Examining the Effectiveness of Mindfulness-Based 
Cognitive Therapy for Anxiety and Stress Reduction within College Students” 
 
 
clinicaltrials.gov #  
 
conducted by Matthew. B. Pontifex, Ph.D. 
 
July 18, 2023 
 
 
 

NCT# 
 
2 
“Cluster-randomized Controlled Trial Examining the Effectiveness of Mindfulness-Based 
Cognitive Therapy for Anxiety and Stress Reduction within College Students” 
 
Abstract: The objective of this project is to understand the potential effectiveness of a 4 
week Mindfulness-Based Cognitive Therapy intervention delivered using a smartphone 
application for reducing anxiety and stress within college students. Although in-person 
mindfulness-based cognitive therapy approaches have been found effective for reducing 
anxiety and stress; given the pervasiveness of anxiety and stress in this population, there 
is a need to provide alternative and accessible interventions to improve students' mental 
health. 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. Accordingly, using a cluster-randomized 
controlled design, this intervention will assess the extent to which 4-weeks of using the 
Sanvello application was effective for reducing anxiety and stress within college students. 
 
Aims:  
1) To provide an assessment of the efficacy of the Sanvello application for reducing 
trait-level anxiety. 
 
2) To provide an assessment of the efficacy of the Sanvello application for reducing 
chronic perceptions of stress. 
 
Number of subjects: 314 individuals enrolled in a predominately freshman level college 
course. 
 
Design: Cluster-randomized positive control Phase 2 clinical trial. 
 
Interventional Study Model: Parallel — Participants are assigned to one of two groups 
in parallel for the duration of the study. 
 
Study Population: The sample consisted of individuals ages 17 to 42 (inclusive) years 
of age enrolled in a predominately freshman level college course in the mid-Michigan, 
USA area.  
 
Eligibility Criteria: 
Criteria for inclusion: All individuals enrolled in the course that agreed to participate 
were enrolled. No individual was turned down due to sex, race, or ethnicity.  
 
Exclusion criteria: The following exclusion criteria exist for all participants: 
a. Lack of consent. 
b. Complete inattendance in the college course during the pretest assessment and 
intervention period.  
 
Recruitment: All participants in the course completed either the intervention or control as 
a course activity. Students had the ability to opt out of their data being used for research 
purposes. 

NCT# 
 
3 
 
Protocol: This investigation was approved by the Michigan State University Human 
Research Protection Program. 
 
Pretest: Following consenting/opting out of their data being used for research purposes, 
students completed a series of questionnaires. Each section of students was randomly 
assigned using a serial stratification approach to either the active experimental group or 
the control experimental group. 
 
Experimental arm. The active experimental group received a mindfulness based 
cognitive therapy through the Sanvello 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 
1) Watch, 2) Read, 3) Listen, 4) Plan, 5) Listen – Mindfulness practice. 
 
Positive Control arm. The control experimental group received training on the 
utilization of mindfulness-based stress reduction breathing techniques. 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 cultivate a non-judgmental attitude when 
confronted with potential distractions and 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. 
 
Intervention. Participants were instructed to practice mindfulness daily using their 
instructed approaches for a period of 4 weeks. 
 
Posttest: At the end of the 4 week study period, participants completed the same 
measures as were completed at the start of the study. 
 
 
 

NCT# 
 
4 
Primary Measures:  
 
State-Trait Anxiety Inventory: Trait anxiety was assessed using the trait component of 
the Spielberger State-Trait Inventory (STAI) (Spielberger et al., 1970). The questionnaire 
comprised twenty statements assessing how individuals "generally feel." Participants rate 
their responses to each question on a 4-point Likert scale, with 1 corresponding to "not at 
all" and 4 indicating "very much so." Positively oriented questions that do not indicate 
anxiety, such as "I feel calm," are reverse scored. The possible trait anxiety scores range 
from 20 to 80, with scores above 45 reflecting high trait anxiety levels (Kayikcioglu et al., 
2017).  
 
Perceived Stress Scale: 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.  
 
Aims Assessment:  
1) To provide an assessment of the efficacy of the Sanvello application for reducing 
trait-level anxiety. 
 
This aim was satisfied by examining intervention (active vs positive control) by time 
(pretest vs postest) interactions for the Trait component of the Spielberger State-
Trait Inventory. 
 
2) To provide an assessment of the efficacy of the Sanvello application for reducing 
chronic perceptions of stress. 
 
This aim was satisfied by examining intervention (active vs positive control) by time 
(pretest vs postest) interactions for the Perceived Stress Scale. 
 
Statistical Analysis Plan:  
Data will be analyzed using multi-level modeling as this approach is robust to 
unbalanced data (i.e., missing observations if any occur) and accounts for a number of 
sources of variability. Analyses will be conducted with α = 0.05 and Benjamini-Hochberg 
false discovery rate control = 0.05 for post-hoc decompositions. Dependent variables 
from each primary outcome will be separately assessed using a 2 (Intervention: active, 
positive control) × 2 (Time: pre-test, post-test) univariate multi-level model including the 
random intercept for Participant, Cluster, and Participant by factor interactions if 
appropriate.