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

Not Applicable

Completed

• Conditions: Anxiety; Stress
• Interventions: Behavioral: Mindfulness Practice

• 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

Arm && Interventions

Group	Intervention	Description
Positive Control	Mindfulness Practice	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	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.

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