Completed

Cluster-randomized Controlled Trial Examining the Effectiveness of Mindfulness-Based Cognitive Therapy for Anxiety and Stress Reduction Within College Students

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What is being tested

Mindfulness Practice

Behavioral
Who is being recruted

Anxiety Disorders

+ Mental Disorders

From 17 to 42 Years
+3 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: March 2023
See protocol details

Summary

Principal SponsorMichigan State University
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: March 21, 2023

Actual date on which the first participant was enrolled.

This study aims to explore how effective a smartphone app called Sanvello is in helping college students reduce anxiety and stress. College students often experience high levels of anxiety and stress, so finding accessible ways to help them manage these issues is important. Although traditional, in-person mindfulness-based therapies have shown success, using a smartphone app could make these benefits available to many more students by providing an easy-to-access, convenient option for improving mental health. Participants in the study will use the Sanvello app for four weeks to practice mindfulness-based cognitive therapy. The app provides exercises and techniques to help reduce anxiety and stress. The study will measure how well the app works in lowering stress and anxiety levels among the students. By using a cluster-randomized controlled design, the study ensures that the results are reliable and can show if the app truly helps in managing stress and anxiety effectively.

Official TitleCluster-randomized Controlled Trial Examining the Effectiveness of Mindfulness-Based Cognitive Therapy for Anxiety and Stress Reduction Within College Students
NCT06019299
Principal SponsorMichigan State University
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

289 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 17 to 42 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Anxiety DisordersMental Disorders

Criteria

1 inclusion criteria required to participate
Enrolled in course

2 exclusion criteria prevent from participating
Complete inattendance in course during the pretest and study period.

Opted out of data being available for research use

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
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.

Group II

Active Comparator
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.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Department of Kinesiology

East Lansing, United StatesOpen Department of Kinesiology in Google Maps
CompletedOne Study Center