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

Anxiety Clinical Trial

Official title:

Cluster-randomized Controlled Trial Examining the Effectiveness of Mindfulness-Based Cognitive Therapy for Anxiety and Stress Reduction Within College Students

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06019299
• Other study ID #: STUDY00008121
• Status: Completed
• Phase: N/A
• Start date: March 21, 2023
• Est. completion date: April 26, 2023

Study information

• Verified date: August 2023
• Source: Michigan State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 289
• Est. completion date: April 26, 2023
• Est. primary completion date: April 26, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 17 Years to 42 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Stress

Intervention

Behavioral:
• Mindfulness Practice
Participants were instructed to practice mindfulness daily using their instructed approaches for a period of 4 weeks.

Locations

Country	Name	City	State
United States	Department of Kinesiology	East Lansing	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Michigan State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	State-Trait Anxiety Inventory	Trait scale of the Spielberger State-Trait Inventory as an index of trait anxiety	Change from baseline, 4 weeks.
Primary	Perceived Stress Scale	The Perceived Stress Scale-4 as an index of perceived chronic stress levels	Change from baseline, 4 weeks.