COMPASS: Comprehensive Mobile Precision Approach for Scalable Solutions in Mental Health Treatment
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Sponsor
- University of Michigan
- Enrollment
- 4,400
- Locations
- 1
- Primary Endpoint
- Depression as measured by the Patient Health Questionnaire 9(PHQ-9)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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+)
Arms & Interventions
Mindfulness with tailored messages
Participants will receive an app-based intervention, tailored messages from the MyDataHelps study app, and activity tracker.
Intervention: Mindfulness + Tailored Messages (Behavioral)
Mindfulness without tailored messages
Participants will receive an app-based intervention and standard feedback from activity tracker.
Intervention: Mindfulness without Tailored Messages (Behavioral)
Cognitive Behavioral Therapy (CBT) with tailored messages
Participants will receive an app-based intervention, tailored messages from the MyDataHelps study app, and activity tracker.
Intervention: Cognitive Behavioral Therapy (CBT) + Tailored Messages (Behavioral)
Cognitive Behavioral Therapy (CBT) without tailored messages
Participants will receive an app-based intervention and standard feedback from activity tracker.
Intervention: Cognitive Behavioral Therapy (CBT) without Tailored Messages (Behavioral)
Outcomes
Primary Outcomes
Depression as measured by the Patient Health Questionnaire 9(PHQ-9)
Time Frame: 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
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Amy S.B. Bohnert
Professor
University of Michigan