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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06019299
Enrollment
289
Registered
2023-08-31
Start date
2023-03-21
Completion date
2023-04-26
Last updated
2023-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Stress

Keywords

Mindfulness-Based Cognitive Therapy

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.

Interventions

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

Sponsors

Michigan State University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
17 Years to 42 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
State-Trait Anxiety InventoryChange from baseline, 4 weeks.Trait scale of the Spielberger State-Trait Inventory as an index of trait anxiety
Perceived Stress ScaleChange from baseline, 4 weeks.The Perceived Stress Scale-4 as an index of perceived chronic stress levels

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026