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

NCT ID: NCT06840457

Last Updated: 2025-02-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

4400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-03

Study Completion Date

2029-04-30

Brief Summary

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

Detailed Description

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Conditions

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Mental Health

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Mindfulness with tailored messages

Participants will receive an app-based intervention, tailored messages from the MyDataHelps study app, and activity tracker.

Group Type ACTIVE_COMPARATOR

Mindfulness + Tailored Messages

Intervention Type 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

Participants will receive an app-based intervention and standard feedback from activity tracker.

Group Type ACTIVE_COMPARATOR

Mindfulness without Tailored Messages

Intervention Type BEHAVIORAL

The study will use an app designed to train the user in mindfulness practices.

Cognitive Behavioral Therapy (CBT) with tailored messages

Participants will receive an app-based intervention, tailored messages from the MyDataHelps study app, and activity tracker.

Group Type ACTIVE_COMPARATOR

Cognitive Behavioral Therapy (CBT) + Tailored Messages

Intervention Type 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

Participants will receive an app-based intervention and standard feedback from activity tracker.

Group Type ACTIVE_COMPARATOR

Cognitive Behavioral Therapy (CBT) without Tailored Messages

Intervention Type BEHAVIORAL

The study will use an app designed to deliver cognitive behavioral therapy.

Interventions

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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.

Intervention Type BEHAVIORAL

Mindfulness without Tailored Messages

The study will use an app designed to train the user in mindfulness practices.

Intervention Type 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.

Intervention Type BEHAVIORAL

Cognitive Behavioral Therapy (CBT) without Tailored Messages

The study will use an app designed to deliver cognitive behavioral therapy.

Intervention Type BEHAVIORAL

Other Intervention Names

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Mindfulness Mindfulness CBT CBT

Eligibility Criteria

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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+)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Amy S.B. Bohnert

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Michigan

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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1U01MH136025

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HUM00248932

Identifier Type: -

Identifier Source: org_study_id

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