COMPASS: a Comprehensive Mobile Precision Approach for Scalable Solutions in Mental Health Treatment

Not Applicable

• Conditions: Mental Health

• Registration Number: NCT06840457
• Lead Sponsor: University of Michigan

Brief Summary

This research study is being conducted to understand if patients benefit from mobile health interventions while waiting for in-clinic mental health treatments.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-02
• Study Start: 2025-02-03
• Study First Submitted: 2025-02-17
• Study First Submitted QC: 2025-02-17
• Last Update Submitted: 2025-02-17
• Study First Posted: 2025-02-21
• Last Update Posted: 2025-02-21
• Primary Completion: 2028-09-30
• Study Completion: 2029-04-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 4400

Inclusion Criteria

• Seeking mental health services from Michigan Medicine, University Health Services, or collaborative clinics and services.
• Must have daily access to a smartphone version that is compatible with study activity trackers.
• Understands English to enable consent and use of the MyDataHelps app and app-based interventions

Exclusion Criteria

• Self-reported or medical record indication of a current eating disorder
• Unable to provide informed consent (e.g., cognitive or guardianship restrictions)
• Scheduled outpatient mental health appointment is a pediatric appointment (even if age 18+)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Depression as measured by the Patient Health Questionnaire 9(PHQ-9)	From enrollment to the 6-week assessment.	The PHQ-9 is an instrument for screening, diagnosing, monitoring and measuring the severity of depression: The PHQ-9 incorporates self-report questions on 9 specific depression symptoms that align with the DSM-IV depression diagnostic criteria. PHQ-9 scores range from 0-27 and 27 indicates severe depression.
Anxiety as measured using the Generalized Anxiety Disorder 7-Item (GAD-7) Scale	From enrollment to the 6-week assessment.	GAD-7 consists total score for the seven items ranges from 0 to 21. Scores of 5, 10, and 15 represent cut points for mild, moderate, and severe anxiety, respectively.

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States