COMPASS: a Comprehensive Mobile Precision Approach for Scalable Solutions in Mental Health Treatment
COMPASS
COMPASS: Comprehensive Mobile Precision Approach for Scalable Solutions in Mental Health Treatment
2 other identifiers
interventional
4,400
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2025
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 3, 2025
CompletedFirst Submitted
Initial submission to the registry
February 17, 2025
CompletedFirst Posted
Study publicly available on registry
February 21, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 30, 2029
February 21, 2025
February 1, 2025
3.7 years
February 17, 2025
February 17, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Depression as measured by the Patient Health Questionnaire 9(PHQ-9)
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
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.
Study Arms (4)
Mindfulness with tailored messages
ACTIVE COMPARATORParticipants will receive an app-based intervention, tailored messages from the MyDataHelps study app, and activity tracker.
Mindfulness without tailored messages
ACTIVE COMPARATORParticipants will receive an app-based intervention and standard feedback from activity tracker.
Cognitive Behavioral Therapy (CBT) with tailored messages
ACTIVE COMPARATORParticipants will receive an app-based intervention, tailored messages from the MyDataHelps study app, and activity tracker.
Cognitive Behavioral Therapy (CBT) without tailored messages
ACTIVE COMPARATORParticipants will receive an app-based intervention and standard feedback from activity tracker.
Interventions
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.
The study will use an app designed to train the user in mindfulness practices.
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.
The study will use an app designed to deliver cognitive behavioral therapy.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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+)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Michiganlead
- National Institute of Mental Health (NIMH)collaborator
Study Sites (1)
University of Michigan
Ann Arbor, Michigan, 48109, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
February 17, 2025
First Posted
February 21, 2025
Study Start
February 3, 2025
Primary Completion (Estimated)
September 30, 2028
Study Completion (Estimated)
April 30, 2029
Last Updated
February 21, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will share
Shared within National Institute of Mental Health Data Archive via grant data collaborator core.