COMPASS: A Comprehensive Mobile Precision Approach for Scalable Solutions in Mental Health Treatment (COMPASS)
June 17, 2026 updated by: Amy S.B. Bohnert, University of Michigan
COMPASS: Comprehensive Mobile Precision Approach for Scalable Solutions in Mental Health Treatment
This research study is being conducted to understand if patients benefit from mobile health interventions while waiting for in-clinic mental health treatments.
Study Overview
Status
Enrolling by invitation
Conditions
Study Type
Interventional
Enrollment (Estimated)
4400
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Michigan
-
Ann Arbor, Michigan, United States, 48109
- University of Michigan
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Mindfulness with tailored messages
Participants will receive an app-based intervention, tailored messages from the MyDataHelps study app, and activity tracker.
|
Tailored Messages (TM) Participants randomized to receive enhanced feedback will receive this feedback from the MyDataHelps study app. This includes varying types of text and visual feedback based on data collected through the app. Messages will be displayed to participants on a dashboard in the app or delivered via pop-up notifications. Participants will receive a combination of text and visual messages. The study will use an app designed to train the user in mindfulness practices.
Other Names:
|
|
Active Comparator: Mindfulness without tailored messages
Participants will receive an app-based intervention and standard feedback from activity tracker.
|
The study will use an app designed to train the user in mindfulness practices.
Other Names:
|
|
Active Comparator: Cognitive Behavioral Therapy (CBT) with tailored messages
Participants will receive an app-based intervention, tailored messages from the MyDataHelps study app, and activity tracker.
|
Tailored Messages (TM) Participants randomized to receive enhanced feedback will receive this feedback from the MyDataHelps study app. This includes varying types of text and visual feedback based on data collected through the app. Messages will be displayed to participants on a dashboard in the app or delivered via pop-up notifications. Participants will receive a combination of text and visual messages. The study will use an app designed to deliver cognitive behavioral therapy.
Other Names:
|
|
Active Comparator: Cognitive Behavioral Therapy (CBT) without tailored messages
Participants will receive an app-based intervention and standard feedback from activity tracker.
|
The study will use an app designed to deliver cognitive behavioral therapy.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
From enrollment to the 6-week assessment.
|
|
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.
|
From enrollment to the 6-week assessment.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 3, 2025
Primary Completion (Estimated)
September 30, 2028
Study Completion (Estimated)
April 30, 2029
Study Registration Dates
First Submitted
February 17, 2025
First Submitted That Met QC Criteria
February 17, 2025
First Posted (Actual)
February 21, 2025
Study Record Updates
Last Update Posted (Actual)
June 22, 2026
Last Update Submitted That Met QC Criteria
June 17, 2026
Last Verified
June 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HUM00248932
- 1U01MH136025 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Shared within National Institute of Mental Health Data Archive via grant data collaborator core.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.