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Enrolling by Invitation

NCT Number: NCT06840457

COMPASS: A 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.

Enrolling by Invitation

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Key information

Conditions

Mental Health Behavior Personal Satisfaction Psychological Well-Being

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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+)

Treatment and study plan

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.

Other names: Mindfulness

Mindfulness without Tailored Messages

Behavioral

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

Other names: Mindfulness

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.

Other names: CBT

Cognitive Behavioral Therapy (CBT) without Tailored Messages

Behavioral

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

Other names: CBT

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

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

Acronym: COMPASS

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Feb 21, 2025
Registry last updated
Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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