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

NCT ID: NCT06019299

Last Updated: 2023-08-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 289 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-21
• Study Completion Date: 2023-04-26

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.

Conditions

Anxiety; Stress

Keywords

Mindfulness-Based Cognitive Therapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Mindfulness Practice

Intervention Type: BEHAVIORAL

Participants were instructed to practice mindfulness daily using their instructed approaches for a period of 4 weeks.

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.

Group Type: EXPERIMENTAL

Mindfulness Practice

Intervention Type: BEHAVIORAL

Participants were instructed to practice mindfulness daily using their instructed approaches for a period of 4 weeks.

Interventions

Mindfulness Practice

Participants were instructed to practice mindfulness daily using their instructed approaches for a period of 4 weeks.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 17 Years
• Maximum Eligible Age: 42 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Michigan State University

OTHER

Sponsor Role: lead

Responsible Party

Matthew B. Pontifex, Ph.D.

Professor of Kinesiology and Psychology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Matthew B Pontifex, PhD

Role: PRINCIPAL_INVESTIGATOR

Michigan State University

Locations

Department of Kinesiology

East Lansing, Michigan, United States

Countries

United States

References

Ellison OK, Bullard LE, Lee GK, Vazou S, Pfeiffer KA, Baez SE, Pontifex MB. Examining efficacy and potential mechanisms of mindfulness-based cognitive therapy for anxiety and stress reduction among college students in a cluster-randomized controlled trial. Int J Clin Health Psychol. 2024 Oct-Dec;24(4):100514. doi: 10.1016/j.ijchp.2024.100514. Epub 2024 Oct 29.

Reference Type: DERIVED

PMID: 39525940 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

STUDY00008121

Identifier Type: -

Identifier Source: org_study_id