Cluster-randomized Controlled Trial of Mindfulness-Based Cognitive Therapy Effects on Anxiety and Stress

Not Applicable

Completed

• Conditions: Anxiety; Stress

• Registration Number: NCT06019299
• Lead Sponsor: Michigan State University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2023-03-21
• Primary Completion: 2023-04-26
• Study Completion: 2023-04-26
• Study First Submitted: 2023-07-18
• Status Verified: 2023-08
• Study First Submitted QC: 2023-08-24
• Last Update Submitted: 2023-08-24
• Study First Posted: 2023-08-31
• Last Update Posted: 2023-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 289

Inclusion Criteria

• Enrolled in course

Exclusion Criteria

• Complete inattendance in course during the pretest and study period.
• Opted out of data being available for research use

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Perceived Stress Scale	Change from baseline, 4 weeks.	The Perceived Stress Scale-4 as an index of perceived chronic stress levels
State-Trait Anxiety Inventory	Change from baseline, 4 weeks.	Trait scale of the Spielberger State-Trait Inventory as an index of trait anxiety

Trial Locations

Locations (1)

Department of Kinesiology; 🇺🇸 East Lansing, Michigan, United States