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

Primary Purpose

Anxiety, Stress

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness Practice
Sponsored by
Michigan State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety focused on measuring Mindfulness-Based Cognitive Therapy

Eligibility Criteria

17 Years - 42 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Department of Kinesiology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Positive Control

Mindfulness-Based Cognitive Therapy intervention

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

State-Trait Anxiety Inventory
Trait scale of the Spielberger State-Trait Inventory as an index of trait anxiety
Perceived Stress Scale
The Perceived Stress Scale-4 as an index of perceived chronic stress levels

Secondary Outcome Measures

Full Information

First Posted
July 18, 2023
Last Updated
August 24, 2023
Sponsor
Michigan State University
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1. Study Identification

Unique Protocol Identification Number
NCT06019299
Brief Title
Cluster-randomized Controlled Trial of Mindfulness-Based Cognitive Therapy Effects on Anxiety and Stress
Official Title
Cluster-randomized Controlled Trial Examining the Effectiveness of Mindfulness-Based Cognitive Therapy for Anxiety and Stress Reduction Within College Students
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
March 21, 2023 (Actual)
Primary Completion Date
April 26, 2023 (Actual)
Study Completion Date
April 26, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Michigan State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Stress
Keywords
Mindfulness-Based Cognitive Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Cluster randomized allocation to Mindfulness-Based Cognitive Therapy intervention or positive control intervention.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
289 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Positive Control
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Mindfulness-Based Cognitive Therapy intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness Practice
Intervention Description
Participants were instructed to practice mindfulness daily using their instructed approaches for a period of 4 weeks.
Primary Outcome Measure Information:
Title
State-Trait Anxiety Inventory
Description
Trait scale of the Spielberger State-Trait Inventory as an index of trait anxiety
Time Frame
Change from baseline, 4 weeks.
Title
Perceived Stress Scale
Description
The Perceived Stress Scale-4 as an index of perceived chronic stress levels
Time Frame
Change from baseline, 4 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
42 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew B Pontifex, PhD
Organizational Affiliation
Michigan State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Kinesiology
City
East Lansing
State/Province
Michigan
ZIP/Postal Code
48824
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data sharing will be by request and approval of the Michigan State University Human Research Protections Program with the provision of a data-safety and sharing agreement. No individually identifiable information will be shared.
IPD Sharing Time Frame
Data will be available following primary publication of the results.
IPD Sharing Access Criteria
By request and completion of an institutional data-safety and sharing agreement.

Learn more about this trial

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

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