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

NCT06019299 | Completed Results

• 1 other identifier: STUDY00008121
• Study Type: interventional
• Target: 289
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety; Stress

Keywords

Mindfulness-Based Cognitive Therapy

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Change from baseline, 4 weeks.

Study Arms (2)

Positive Control

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.

Behavioral: Mindfulness Practice

Mindfulness-Based Cognitive Therapy intervention

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.

Behavioral: Mindfulness Practice

Interventions

Mindfulness Practice BEHAVIORAL

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

Mindfulness-Based Cognitive Therapy intervention; Positive Control

Eligibility Criteria

• Age: 17 Years - 42 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Enrolled in course

You may not qualify if:

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

Sponsors & Collaborators

• Michigan State University: lead

Study Sites (1)

Department of Kinesiology

East Lansing, Michigan, 48824, United States

Location

Related Publications (1)

• 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.

  PMID: 39525940 DERIVED

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Limitations and Caveats

Although the intervention was not a priori designed as a crisis interventional approach, it was implemented only a month after a mass-shooting event occurred on campus. Thus as Foa et al. (2005, doi: 10.1037/0022-006X.73.5.953), observed that cognitive restructuring had limited effects on individuals with post-traumatic stress disorder (PTSD) and their perceived levels of chronic stress; it is important to acknowledge and consider the limitations this might introduce.

Results Point of Contact

• Title: Matthew B. Pontifex
• Organization: Michigan State University

pontifex@msu.edu

(517) 355-4730

Study Officials

• Matthew B Pontifex, PhD

  Michigan State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Kinesiology and Psychology

Model Details: Cluster randomized allocation to Mindfulness-Based Cognitive Therapy intervention or positive control intervention.

Study Record Dates

• First Submitted: July 18, 2023
• First Posted: August 31, 2023
• Study Start: March 21, 2023
• Primary Completion: April 26, 2023
• Study Completion: April 26, 2023
• Last Updated: June 12, 2026
• Results First Posted: June 12, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be available following primary publication of the results.
• Access Criteria: By request and completion of an institutional data-safety and sharing agreement.

Locations

US (1)