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

Michigan State University

Status: Completed

Conditions: Anxiety; Stress

Treatments: Behavioral: Mindfulness Practice

Study type: Interventional

Funder types: Other

Identifiers

NCT06019299

STUDY00008121

Details and patient eligibility

About

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.

Full 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.

Enrollment: 289 patients

Sex: All

Ages: 17 to 42 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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289 participants in 2 patient groups

Positive Control

Active Comparator group

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.

Treatment:

Behavioral: Mindfulness Practice

Mindfulness-Based Cognitive Therapy intervention

Experimental group

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.

Treatment:

Behavioral: Mindfulness Practice