Mental HealthCOMPASSNCT06840457
COMPASS: A Comprehensive Mobile Precision Approach for Scalable Solutions in Mental Health Treatment
A study testing Mindfulness + Tailored Messages, Mindfulness without Tailored Messages and Cognitive Behavioral Therapy (CBT) + Tailored Messages in people with Mental Health, run by University of Michigan at 1 site in United States.
Trial summary
This research study is being conducted to understand if patients benefit from mobile health interventions while waiting for in-clinic mental health treatments. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mental Health
- What is being tested?
- Mindfulness + Tailored Messages, Mindfulness without Tailored Messages and Cognitive Behavioral Therapy (CBT) + Tailored Messages
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,400 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Feb 2025to 30 Apr 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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+)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Mental Health
- Being tested
- Mindfulness + Tailored Messages, Mindfulness without Tailored Messages, Cognitive Behavioral Therapy (CBT) + Tailored Messages, Cognitive Behavioral Therapy (CBT) without Tailored Messages
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness + Tailored MessagesBehavioural
Also called Mindfulness
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 MessagesBehavioural
Also called Mindfulness
The study will use an app designed to train the user in mindfulness practices.
Cognitive Behavioral Therapy (CBT) + Tailored MessagesBehavioural
Also called CBT
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 MessagesBehavioural
Also called CBT
The study will use an app designed to deliver cognitive behavioral therapy.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness with tailored messages | Active comparator | Participants will receive an app-based intervention, tailored messages from the MyDataHelps study app, and activity tracker. Receives: Behavioral: Mindfulness + Tailored Messages |
| Mindfulness without tailored messages | Active comparator | Participants will receive an app-based intervention and standard feedback from activity tracker. Receives: Behavioral: Mindfulness without Tailored Messages |
| Cognitive Behavioral Therapy (CBT) with tailored messages | Active comparator | Participants will receive an app-based intervention, tailored messages from the MyDataHelps study app, and activity tracker. Receives: Behavioral: Cognitive Behavioral Therapy (CBT) + Tailored Messages |
| Cognitive Behavioral Therapy (CBT) without tailored messages | Active comparator | Participants will receive an app-based intervention and standard feedback from activity tracker. Receives: Behavioral: Cognitive Behavioral Therapy (CBT) without Tailored Messages |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression as measured by the Patient Health Questionnaire 9(PHQ-9)
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.
Measured: From enrollment to the 6-week assessment.
Anxiety as measured using the Generalized Anxiety Disorder 7-Item (GAD-7) Scale
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.
Measured: From enrollment to the 6-week assessment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2025
- Study start3 Feb 2025
- Primary completion30 Sep 2028 (estimated)
- Study completion30 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental HealthStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Amy S.B. Bohnert, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06840457
- Sponsor's protocol ID
- HUM00248932
- Other IDs
- 1U01MH136025
- Acronym
- COMPASS
- Status last verified
- Jun 2026
- First submitted
- 17 Feb 2025
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Shared within National Institute of Mental Health Data Archive via grant data collaborator core.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMPASS: Comprehensive Mobile Precision Approach for Scalable Solutions in Mental Health Treatment
- ClinicalTrials.gov ID
- NCT06840457
- Acronym / sponsor ID
- COMPASS / HUM00248932
- Conditions
- Mental Health
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 4,400 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 3 Feb 2025 (actual)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 30 Apr 2029 (estimated)
- First posted
- 21 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research study is being conducted to understand if patients benefit from mobile health interventions while waiting for in-clinic mental health treatments.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Mindfulness with tailored messages | Active comparator | Behavioral: Mindfulness + Tailored MessagesParticipants will receive an app-based intervention, tailored messages from the MyDataHelps study app, and activity tracker. |
| Mindfulness without tailored messages | Active comparator | Behavioral: Mindfulness without Tailored MessagesParticipants will receive an app-based intervention and standard feedback from activity tracker. |
| Cognitive Behavioral Therapy (CBT) with tailored messages | Active comparator | Behavioral: Cognitive Behavioral Therapy (CBT) + Tailored MessagesParticipants will receive an app-based intervention, tailored messages from the MyDataHelps study app, and activity tracker. |
| Cognitive Behavioral Therapy (CBT) without tailored messages | Active comparator | Behavioral: Cognitive Behavioral Therapy (CBT) without Tailored MessagesParticipants will receive an app-based intervention and standard feedback from activity tracker. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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+)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness + Tailored MessagesAlso: MindfulnessTailored 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. | Behavioural | Mindfulness with tailored messages |
| Mindfulness without Tailored MessagesAlso: MindfulnessThe study will use an app designed to train the user in mindfulness practices. | Behavioural | Mindfulness without tailored messages |
| Cognitive Behavioral Therapy (CBT) + Tailored MessagesAlso: CBTTailored 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. | Behavioural | Cognitive Behavioral Therapy (CBT) with tailored messages |
| Cognitive Behavioral Therapy (CBT) without Tailored MessagesAlso: CBTThe study will use an app designed to deliver cognitive behavioral therapy. | Behavioural | Cognitive Behavioral Therapy (CBT) without tailored messages |
Primary outcome
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Individual participant dataSharing planned: Yes. Shared within National Institute of Mental Health Data Archive via grant data collaborator core.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness + Tailored Messages, Mindfulness without Tailored Messages and Cognitive Behavioral Therapy (CBT) + Tailored Messages in people with Mental Health, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression as measured by the Patient Health Questionnaire 9(PHQ-9) (time frame: From enrollment to the 6-week assessment.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.