Enrolling by invitation NCT06840457
COMPASS: A Comprehensive Mobile Precision Approach for Scalable Solutions in Mental Health Treatment
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Mindfulness + Tailored Messages, Mindfulness without Tailored Messages, Cognitive Behavioral Therapy (CBT) + Tailored Messages, Cognitive Behavioral Therapy (CBT) without Tailored Messages.
- Who it may be relevant to
- Registry conditions: Mental Health. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
COMPASS: Comprehensive Mobile Precision Approach for Scalable Solutions in Mental Health Treatment
Overview
This research study is being conducted to understand if patients benefit from mobile health interventions while waiting for in-clinic mental health treatments.
Interventions
- 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. - Behavioral Mindfulness without Tailored Messages
The study will use an app designed to train the user in mindfulness practices. - 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. - Behavioral Cognitive Behavioral Therapy (CBT) without Tailored Messages
The study will use an app designed to deliver cognitive behavioral therapy.
Primary outcome measures
- Depression as measured by the Patient Health Questionnaire 9(PHQ-9) [Time frame: 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.]
Eligibility criteria
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+)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
United States · 1 center
- University of Michigan — Ann Arbor
Identifiers
NCT: NCT06840457 · HUM00248932 · 1U01MH136025