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

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
University of Michigan
Study ID
NCT06840457
Status
Enrolling By Invitation

Conditions

  • Mental Health

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Mindfulness + Tailored Messages — BEHAVIORAL
    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.
  • Mindfulness without Tailored Messages — BEHAVIORAL
    The study will use an app designed to train the user in mindfulness practices.
  • Cognitive Behavioral Therapy (CBT) + Tailored Messages — BEHAVIORAL
    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.
  • Cognitive Behavioral Therapy (CBT) without Tailored Messages — BEHAVIORAL
    The study will use an app designed to deliver cognitive behavioral therapy.

Study Details

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

Key Dates

Start date
Feb 3, 2025
Status verified
Feb 2025
Primary completion
Sep 30, 2028
Completion
Apr 30, 2029

Study Design

Enrollment
4,400 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Active Comparator: Mindfulness with tailored messages
    Participants will receive an app-based intervention, tailored messages from the MyDataHelps study app, and activity tracker.
  • Active Comparator: Mindfulness without tailored messages
    Participants will receive an app-based intervention and standard feedback from activity tracker.
  • 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.
  • Active Comparator: Cognitive Behavioral Therapy (CBT) without tailored messages
    Participants will receive an app-based intervention and standard feedback from activity tracker.

Primary Outcome Measure

Depression as measured by the Patient Health Questionnaire 9(PHQ-9) [ Time Frame: From enrollment to the 6-week assessment. ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of MichiganAnn ArborMichigan48109-

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By research site
University of Michigan· Ann Arbor, MI

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