An interventional study of Mindfulness Practice in Anxiety and Stress, sponsored by Michigan State University. Completed at 1 site in United States. Open to participants aged 17 Years to 42 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-12.
Sponsored by Michigan State University · Not applicable, Interventional, and Treatment
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.
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.
4,868 studies on the registry are indexed under Anxiety Disorders; 1,390 are open to participants now.
This study's enrollment of 289 is above the median of 80 across 4,174 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →Michigan State University is the lead sponsor of 139 studies on the registry; 26 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Behavioral: Mindfulness Practice
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.
Behavioral: Mindfulness Practice
Participants were instructed to practice mindfulness daily using their instructed approaches for a period of 4 weeks.
State-Trait Anxiety Inventory
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.
Time frame: Change from baseline, 4 weeks.
Perceived Stress Scale
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.
Time frame: Change from baseline, 4 weeks.
Potential participants were enrolled in a single predominately first year-level college course in health-sciences at Michigan State University.
| Milestone | Positive Control | Mindfulness-Based Cognitive Therapy Intervention |
|---|---|---|
| Started | 139 | 150 |
| Completed | 139 | 150 |
| Not completed | 0 | 0 |
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.
| Scale Rating | Positive Control | Mindfulness-Based Cognitive Therapy Intervention |
|---|---|---|
| Pretest (Baseline) | 47.1 ± 4.5 | 47.4 ± 4.5 |
| Posttest (4 weeks following Baseline) | 46.9 ± 4.6 | 45.5 ± 5.1 |
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.
| Scale Rating | Positive Control | Mindfulness-Based Cognitive Therapy Intervention |
|---|---|---|
| Pretest (Baseline) | 8.6 ± 2.7 | 8.6 ± 2.6 |
| Posttest (4 weeks following Baseline) | 8.2 ± 3.0 | 7.5 ± 2.4 |
Collected over From enrollment until end of follow-up, up to 4 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Positive Control | 0/139 (0%) | 0/139 (0%) | 0/139 (0%) |
| Mindfulness-Based Cognitive Therapy Intervention | 0/150 (0%) | 0/150 (0%) | 0/150 (0%) |
All randomized participants were included in analysis.
| Age, Continuous(Years) | Positive Control | Mindfulness-Based Cognitive Therapy Intervention | Total |
|---|---|---|---|
| Mean | 19.9 ± 2.4 | 19.4 ± 1.6 | 19.6 ± 2.0 |
| Sex: Female, Male(Participants) | Positive Control | Mindfulness-Based Cognitive Therapy Intervention | Total |
|---|---|---|---|
| Female | 78 | 95 | 173 |
| Male | 61 | 55 | 116 |
| Race (NIH/OMB)(Participants) | Positive Control | Mindfulness-Based Cognitive Therapy Intervention | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 1 | 1 |
| Asian | 6 | 6 | 12 |
| Native Hawaiian or Other Pacific Islander | 1 | 0 | 1 |
| Black or African American | 5 | 7 | 12 |
| White | 116 | 120 | 236 |
| More than one race | 7 | 13 | 20 |
| Unknown or Not Reported | 4 | 3 | 7 |
| Ethnicity (NIH/OMB)(Participants) | Positive Control | Mindfulness-Based Cognitive Therapy Intervention | Total |
|---|---|---|---|
| Hispanic or Latino | 4 | 3 | 7 |
| Not Hispanic or Latino | 135 | 147 | 282 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Education(Years) | Positive Control | Mindfulness-Based Cognitive Therapy Intervention | Total |
|---|---|---|---|
| Mean | 13.4 ± 0.8 | 13.9 ± 1.0 | 13.7 ± 0.9 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Data sharing will be by request and approval of the Michigan State University Human Research Protections Program with the provision of a data-safety and sharing agreement. No individually identifiable information will be shared.
Supporting information: Study protocol, Sap, Icf
This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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