Trial Outcomes & Findings for Cluster-randomized Controlled Trial of Mindfulness-Based Cognitive Therapy Effects on Anxiety and Stress (NCT NCT06019299)
NCT ID: NCT06019299
Last Updated: 2026-06-12
Results Overview
Trait scale of the Spielberger State-Trait Inventory as an index of trait anxiety. The possible trait scores range from 20 to 80, with higher scores indicating greater levels of anxiety.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
289 participants
Primary outcome timeframe
Change from baseline, 4 weeks.
Results posted on
2026-06-12
Participant Flow
Potential participants were enrolled in a single predominately first year-level college course in health-sciences at Michigan State University.
Unit of analysis: Course Sections
Participant milestones
| Measure |
Positive Control
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.
|
Mindfulness-Based Cognitive Therapy Intervention
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.
|
|---|---|---|
|
Overall Study
STARTED
|
139 4
|
150 4
|
|
Overall Study
COMPLETED
|
139 4
|
150 4
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
All participants were included in analysis.
Baseline characteristics by cohort
| Measure |
Positive Control
n=139 Participants
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.
|
Mindfulness-Based Cognitive Therapy Intervention
n=150 Participants
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.
|
Total
n=289 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
19.9 Years
STANDARD_DEVIATION 2.4 • n=9 Participants
|
19.4 Years
STANDARD_DEVIATION 1.6 • n=27 Participants
|
19.6 Years
STANDARD_DEVIATION 2.0 • n=267 Participants
|
|
Sex: Female, Male
Female
|
78 Participants
n=9 Participants • All participants were included in analysis.
|
95 Participants
n=27 Participants • All participants were included in analysis.
|
173 Participants
n=267 Participants • All participants were included in analysis.
|
|
Sex: Female, Male
Male
|
61 Participants
n=9 Participants • All participants were included in analysis.
|
55 Participants
n=27 Participants • All participants were included in analysis.
|
116 Participants
n=267 Participants • All participants were included in analysis.
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants • All participants were included in analysis.
|
1 Participants
n=27 Participants • All participants were included in analysis.
|
1 Participants
n=267 Participants • All participants were included in analysis.
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=9 Participants • All participants were included in analysis.
|
6 Participants
n=27 Participants • All participants were included in analysis.
|
12 Participants
n=267 Participants • All participants were included in analysis.
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=9 Participants • All participants were included in analysis.
|
0 Participants
n=27 Participants • All participants were included in analysis.
|
1 Participants
n=267 Participants • All participants were included in analysis.
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=9 Participants • All participants were included in analysis.
|
7 Participants
n=27 Participants • All participants were included in analysis.
|
12 Participants
n=267 Participants • All participants were included in analysis.
|
|
Race (NIH/OMB)
White
|
116 Participants
n=9 Participants • All participants were included in analysis.
|
120 Participants
n=27 Participants • All participants were included in analysis.
|
236 Participants
n=267 Participants • All participants were included in analysis.
|
|
Race (NIH/OMB)
More than one race
|
7 Participants
n=9 Participants • All participants were included in analysis.
|
13 Participants
n=27 Participants • All participants were included in analysis.
|
20 Participants
n=267 Participants • All participants were included in analysis.
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=9 Participants • All participants were included in analysis.
|
3 Participants
n=27 Participants • All participants were included in analysis.
|
7 Participants
n=267 Participants • All participants were included in analysis.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=9 Participants • All participants were included in analysis.
|
3 Participants
n=27 Participants • All participants were included in analysis.
|
7 Participants
n=267 Participants • All participants were included in analysis.
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
135 Participants
n=9 Participants • All participants were included in analysis.
|
147 Participants
n=27 Participants • All participants were included in analysis.
|
282 Participants
n=267 Participants • All participants were included in analysis.
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants • All participants were included in analysis.
|
0 Participants
n=27 Participants • All participants were included in analysis.
|
0 Participants
n=267 Participants • All participants were included in analysis.
|
|
Education
|
13.4 Years
STANDARD_DEVIATION 0.8 • n=9 Participants • All participants were included in analysis.
|
13.9 Years
STANDARD_DEVIATION 1.0 • n=27 Participants • All participants were included in analysis.
|
13.7 Years
STANDARD_DEVIATION 0.9 • n=267 Participants • All participants were included in analysis.
|
PRIMARY outcome
Timeframe: Change from baseline, 4 weeks.Population: All randomized participants were included in analysis.
Trait scale of the Spielberger State-Trait Inventory as an index of trait anxiety. The possible trait scores range from 20 to 80, with higher scores indicating greater levels of anxiety.
Outcome measures
| Measure |
Positive Control
n=139 Participants
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.
|
Mindfulness-Based Cognitive Therapy Intervention
n=150 Participants
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.
|
|---|---|---|
|
State-Trait Anxiety Inventory
Pretest (Baseline)
|
47.1 Scale Rating
Standard Error 4.5
|
47.4 Scale Rating
Standard Error 4.5
|
|
State-Trait Anxiety Inventory
Posttest (4 weeks following Baseline)
|
46.9 Scale Rating
Standard Error 4.6
|
45.5 Scale Rating
Standard Error 5.1
|
PRIMARY outcome
Timeframe: Change from baseline, 4 weeks.Population: All randomized participants were included in analysis.
The Perceived Stress Scale-4 as an index of perceived chronic stress levels. The possible scores range from 0 to 16, with higher scores indicating higher perceived chronic stress levels.
Outcome measures
| Measure |
Positive Control
n=139 Participants
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.
|
Mindfulness-Based Cognitive Therapy Intervention
n=150 Participants
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.
|
|---|---|---|
|
Perceived Stress Scale
Pretest (Baseline)
|
8.6 Scale Rating
Standard Error 2.7
|
8.6 Scale Rating
Standard Error 2.6
|
|
Perceived Stress Scale
Posttest (4 weeks following Baseline)
|
8.2 Scale Rating
Standard Error 3.0
|
7.5 Scale Rating
Standard Error 2.4
|
Adverse Events
Positive Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Mindfulness-Based Cognitive Therapy Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place