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

February 17, 2025 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

Intervention / Treatment

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

  • United States
    • 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.
Behavioral: Mindfulness + Tailored Messages

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:
  • Mindfulness
Active Comparator: Mindfulness without tailored messages
Participants will receive an app-based intervention and standard feedback from activity tracker.
Behavioral: Mindfulness without Tailored Messages
The study will use an app designed to train the user in mindfulness practices.
Other Names:
  • Mindfulness
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.
Behavioral: Cognitive Behavioral Therapy (CBT) + Tailored Messages

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:
  • CBT
Active Comparator: Cognitive Behavioral Therapy (CBT) without tailored messages
Participants will receive an app-based intervention and standard feedback from activity tracker.
Behavioral: Cognitive Behavioral Therapy (CBT) without Tailored Messages
The study will use an app designed to deliver cognitive behavioral therapy.
Other Names:
  • CBT

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

University of Michigan

Collaborators

National Institute of Mental Health (NIMH)

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)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 17, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

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.

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