DepressionPROMPTNCT04342494

Providing Mental Health Precision Treatment

A study testing Enhanced Feedback + Standard Feedback, Headspace app + Standard Feedback and Headspace app + Enhanced Feedback + Standard Feedback in people with Depression and Addiction, run by University of Michigan at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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, and to understand which patients receive the most benefit. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Depression, Addiction, Anxiety
What is being tested?: Enhanced Feedback + Standard Feedback, Headspace app + Standard Feedback and Headspace app + Enhanced Feedback + Standard Feedback
Type of treatment: Medical device, Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 2,118 participants
Where: 1 siteUnited States
Study dates: 13 May 2020to 22 Feb 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Must have a scheduled mental health intake appointment at Michigan Medicine Outpatient Psychiatry or University Health Service at the University of Michigan
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
Provide complete, updated contact information upon enrollment to the study
Agree to be contacted by study staff during the study
Willingness to keep study setup (devices, apps, settings) in required configuration for the duration of the study, and following instructions by study staff if required to update or re-achieve required configuration if required configuration has been lost (e.g., change of phone, app deletion)

Who cannot join

Self-reported or medical record indication of a current eating disorder
Scheduled outpatient mental health appointment is a pediatric appointment (even if age 18+)
Wrist too large or too small to wear an Apple Watch or Fitbit comfortably (Note: bands that are shorter or longer than the standard will be made available to minimize this exclusion)

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Michigan
Ann Arbor, Michigan, 48109

Other trials in United States

About this study

Read the detailed description

Initially, results-reporting was planned for 12-month data. However, following 6-week data collection, the participants received other care, so the decision was made to report on the 6-week data.

Conditions: Depression, Addiction, Anxiety, Sleep Disturbance
Being tested: Enhanced Feedback + Standard Feedback, Headspace app + Standard Feedback, Headspace app + Enhanced Feedback + Standard Feedback, SilverCloud + Standard Feedback, SilverCloud app +Enhanced Feedback +Standard Feedback
Keywords: Behavioral health, Precision health
Medical subject headings: Depression, Behavior, Addictive, Anxiety Disorders, Parasomnias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Enhanced Feedback + Standard FeedbackBehavioural
Standard Feedback (SF) All participants will receive the standard feedback that is standard feedback from the activity trackers. Feedback includes activity level, heart rate, and progress toward daily activity goals on the device itself.
Enhanced Feedback (EF) 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. Feedback 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 feedback.
Headspace app + Standard FeedbackDevice
Standard Feedback (SF) All participants will receive the standard feedback that is standard feedback from the activity trackers. Feedback includes activity level, heart rate, and progress toward daily activity goals on the device itself.
Headspace is an app designed to train the user in mindfulness practices.
Headspace app + Enhanced Feedback + Standard FeedbackDevice
Standard Feedback (SF) All participants will receive the standard feedback that is standard feedback from the activity trackers. Feedback includes activity level, heart rate, and progress toward daily activity goals on the device itself.
Enhanced Feedback (EF) 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. Feedback 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 feedback.
Headspace is an app designed to train the user in mindfulness practices.
SilverCloud + Standard FeedbackDevice
Standard Feedback (SF) All participants will receive the standard feedback that is standard feedback from the activity trackers. Feedback includes activity level, heart rate, and progress toward daily activity goals on the device itself.
Silvercloud is an app designed to deliver cognitive behavioral therapy.
SilverCloud app +Enhanced Feedback +Standard FeedbackDevice
Standard Feedback (SF) All participants will receive the standard feedback that is standard feedback from the activity trackers. Feedback includes activity level, heart rate, and progress toward daily activity goals on the device itself.
Enhanced Feedback (EF) 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. Feedback 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 feedback.
Silvercloud is an app designed to deliver cognitive behavioral therapy.

Study groups in NCT04342494
Study group	Role	What they receive
Enhanced Feedback + Standard Feedback	Experimental	Participants will receive enhanced feedback from the MyDataHelps study app in addition to standard feedback from the activity tracker. Receives: Behavioral: Enhanced Feedback + Standard Feedback
Headspace app + Standard Feedback	Experimental	Participants will receive an app-based intervention in addition to standard feedback from the activity tracker. Receives: Device: Headspace app + Standard Feedback
Headspace app + Enhanced Feedback + Standard Feedback	Experimental	Participants will receive an app-based intervention, enhanced feedback from the MyDataHelps study app, and standard feedback activity tracker. Receives: Device: Headspace app + Enhanced Feedback + Standard Feedback
SilverCloud app + Standard Feedback	Experimental	Participants will receive an app-based intervention in addition to standard feedback from the activity tracker. Receives: Device: SilverCloud + Standard Feedback
SilverCloud app +Enhanced Feedback +Standard Feedback	Experimental	Participants will receive an app-based intervention, enhanced feedback from the MyDataHelps study app, and standard feedback from the activity tracker. Receives: Device: SilverCloud app +Enhanced Feedback +Standard Feedback

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Depression as Measured by the Patient Health Questionnaire 9 (PHQ-9)
The PHQ-9 was a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression. The PHQ-9 incorporated self-report questions on 9 specific depression symptoms that align with the DSM-IV depression diagnostic criteria. PHQ-9 scores ranged from 0-27, with 0 indicating no depression and 27 indicating severe depression.
Measured: Up to 6 weeks

Secondary outcomes (5)

Mood as Measured by the Mental Health App Assessment
Participants were asked a single question, "On a scale of 1 to 10, what was your average mood today?" Scores were averaged over follow-up periods with lower scores indicating worse moods and higher scores indicating better moods.
Measured: Daily up to 6 weeks
Change in Suicide Risk as Measured by the Positive and Negative Suicide Ideation Inventory - Positive Ideation (PANSI-PI)
The PANSI-PI subscale consisted of 6 items. The possible total scores on the PANSI-PI subscale ranged from 6 to 30. Lower scores on the PANSI-PI reflected greater risk for suicidal behavior.
Measured: Up to 6 weeks
Change in Suicide Risk as Measured by the Positive and Negative Suicide Ideation Inventory - Negative Suicide Ideation (PANSI-NSI)
The PANSI-NSI subscale was composed of 8 items. The possible total score on the PANSI-NSI ranged from 8 to 40. Higher scores on the PANSI-NSI reflected greater risk for suicidal behavior.
Measured: Up to 6 weeks
Change in Anxiety as Measured Using the Generalized Anxiety Disorder 7-Item (GAD-7) Scale
GAD-7 consisted of the total score for seven items ranging from 0 to 21. Scores of 5, 10, and 15 represented cut points for mild, moderate, and severe anxiety, respectively.
Measured: Up to 6 weeks
Substance Use as Measured by the Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST)
The ASSIST Global Continuum of Illicit Drug Risk Score ranged from 0 to 308, with higher scores indicating greater risk. Results reflect the participants who indicated they had consumed any alcohol, smoked, or used an illicit substance when asked.
Measured: Up to 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 May 202022 Feb 2023

First posted13 Apr 2020
Study start13 May 2020
Primary completion22 Feb 2023
Study completion22 Feb 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for DepressionStudies 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: 2,118 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04342494
Sponsor's protocol ID: HUM00164162
Acronym: PROMPT
Status last verified: Feb 2025
First submitted: 8 Apr 2020
Last updated: 17 Mar 2025
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Horwitz AG, Mills ED, Sen S, Bohnert ASB. Comparative Effectiveness of Three Digital Interventions for Adults Seeking Psychiatric Services: A Randomized Clinical Trial. JAMA Netw Open. 2024 Jul 1;7(7):e2422115. doi: 10.1001/jamanetworkopen.2024.22115.
PubMed 39023893

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Providing Mental Health Precision Treatment
ClinicalTrials.gov ID: NCT04342494
Acronym / sponsor ID: PROMPT / HUM00164162
Conditions: Depression, Addiction, Anxiety, Sleep Disturbance
Keywords: Behavioral health, Precision health
Study type: Interventional
Recruitment status: Completed
Enrolment: 2,118 participants (actual)
Lead sponsor: University of MichiganUniversity, hospital or other
Study start: 13 May 2020 (actual)
Primary completion: 22 Feb 2023 (actual)
Study completion: 22 Feb 2023 (actual)
First posted: 13 Apr 2020 (actual)
Results: Posted 17 Mar 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Initially, results-reporting was planned for 12-month data. However, following 6-week data collection, the participants received other care, so the decision was made to report on the 6-week data.

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 5

Arm	Type	Receives
Enhanced Feedback + Standard Feedback	Experimental	Behavioral: Enhanced Feedback + Standard FeedbackParticipants will receive enhanced feedback from the MyDataHelps study app in addition to standard feedback from the activity tracker.
Headspace app + Standard Feedback	Experimental	Device: Headspace app + Standard FeedbackParticipants will receive an app-based intervention in addition to standard feedback from the activity tracker.
Headspace app + Enhanced Feedback + Standard Feedback	Experimental	Device: Headspace app + Enhanced Feedback + Standard FeedbackParticipants will receive an app-based intervention, enhanced feedback from the MyDataHelps study app, and standard feedback activity tracker.
SilverCloud app + Standard Feedback	Experimental	Device: SilverCloud + Standard FeedbackParticipants will receive an app-based intervention in addition to standard feedback from the activity tracker.
SilverCloud app +Enhanced Feedback +Standard Feedback	Experimental	Device: SilverCloud app +Enhanced Feedback +Standard FeedbackParticipants will receive an app-based intervention, enhanced feedback from the MyDataHelps study app, and standard feedback from the activity tracker.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Must have a scheduled mental health intake appointment at Michigan Medicine Outpatient Psychiatry or University Health Service at the University of Michigan
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
Provide complete, updated contact information upon enrollment to the study
Agree to be contacted by study staff during the study

Key exclusion criteria (3 listed)

Self-reported or medical record indication of a current eating disorder
Scheduled outpatient mental health appointment is a pediatric appointment (even if age 18+)
Wrist too large or too small to wear an Apple Watch or Fitbit comfortably (Note: bands that are shorter or longer than the standard will be made available to minimize this exclusion)

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
Enhanced Feedback + Standard FeedbackStandard Feedback (SF) All participants will receive the standard feedback that is standard feedback from the activity trackers. Feedback includes activity level, heart rate, and progress toward daily activity goals on the device itself. Enhanced Feedback (EF) 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. Feedback 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 feedback.	Behavioural	Enhanced Feedback + Standard Feedback
Headspace app + Standard FeedbackStandard Feedback (SF) All participants will receive the standard feedback that is standard feedback from the activity trackers. Feedback includes activity level, heart rate, and progress toward daily activity goals on the device itself. Headspace is an app designed to train the user in mindfulness practices.	Device	Headspace app + Standard Feedback
Headspace app + Enhanced Feedback + Standard FeedbackStandard Feedback (SF) All participants will receive the standard feedback that is standard feedback from the activity trackers. Feedback includes activity level, heart rate, and progress toward daily activity goals on the device itself. Enhanced Feedback (EF) 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. Feedback 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 feedback. Headspace is an app designed to train the user in mindfulness practices.	Device	Headspace app + Enhanced Feedback + Standard Feedback
SilverCloud + Standard FeedbackStandard Feedback (SF) All participants will receive the standard feedback that is standard feedback from the activity trackers. Feedback includes activity level, heart rate, and progress toward daily activity goals on the device itself. Silvercloud is an app designed to deliver cognitive behavioral therapy.	Device	SilverCloud app + Standard Feedback
SilverCloud app +Enhanced Feedback +Standard FeedbackStandard Feedback (SF) All participants will receive the standard feedback that is standard feedback from the activity trackers. Feedback includes activity level, heart rate, and progress toward daily activity goals on the device itself. Enhanced Feedback (EF) 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. Feedback 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 feedback. Silvercloud is an app designed to deliver cognitive behavioral therapy.	Device	SilverCloud app +Enhanced Feedback +Standard Feedback

Primary outcome

Change in Depression as Measured by the Patient Health Questionnaire 9 (PHQ-9)
Time frame: Up to 6 weeks
The PHQ-9 was a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression. The PHQ-9 incorporated self-report questions on 9 specific depression symptoms that align with the DSM-IV depression diagnostic criteria. PHQ-9 scores ranged from 0-27, with 0 indicating no depression and 27 indicating severe depression.

5 secondary outcomes

Mood as Measured by the Mental Health App Assessment
Time frame: Daily up to 6 weeks
Change in Suicide Risk as Measured by the Positive and Negative Suicide Ideation Inventory - Positive Ideation (PANSI-PI)
Time frame: Up to 6 weeks
Change in Suicide Risk as Measured by the Positive and Negative Suicide Ideation Inventory - Negative Suicide Ideation (PANSI-NSI)
Time frame: Up to 6 weeks
Change in Anxiety as Measured Using the Generalized Anxiety Disorder 7-Item (GAD-7) Scale
Time frame: Up to 6 weeks
Substance Use as Measured by the Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST)
Time frame: Up to 6 weeks

Results and safety

Results posted to the registry on 17 Mar 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Enhanced Feedback + Standard Feedback	690	640
Headspace App + Standard Feedback	349	311
Headspace App + Enhanced Feedback + Standard Feedback	349	313
SilverCloud App + Standard Feedback	345	311
SilverCloud App +Enhanced Feedback +Standard Feedback	346	310

Primary outcome: Change in Depression as Measured by the Patient Health Questionnaire 9 (PHQ-9)

Time frame: Up to 6 weeks. Mean (Standard Deviation). Unit: score on a scale

Measure	Enhanced Feedback + Standard Feedback n = 690	Headspace App + Standard Feedback n = 349	Headspace App + Enhanced Feedback + Standard Feedback n = 349	SilverCloud App + Standard Feedback n = 345	SilverCloud App +Enhanced Feedback +Standard Feedback n = 346
Baseline	12.6 (6.4)	12.5 (6.3)	13.0 (6.8)	13.0 (6.2)	12.8 (6.4)
6 weeks	10.1 (5.8)	9.8 (5.9)	10.1 (5.9)	10.3 (5.9)	10.6 (5.7)

Enhanced Feedback + Standard Feedback vs Headspace App + Standard Feedback vs Headspace App + Enhanced Feedback + Standard Feedback vs SilverCloud App + Standard Feedback vs SilverCloud App +Enhanced Feedback +Standard Feedback: p = 0.31, ANCOVA

Population analysed: Some participants in each arm were lost to follow up or did not complete their questionnaires following the baseline visit. 1 participant's data for the PHQ-9 was missing, but their data for Outcome Measures 3, 4, 5, and 6 was present.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 6 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Enhanced Feedback + Standard Feedback	0 of 690 (0%)	0 of 690 (0%)	0 of 690
Headspace App + Standard Feedback	0 of 349 (0%)	0 of 349 (0%)	0 of 349
Headspace App + Enhanced Feedback + Standard Feedback	0 of 349 (0%)	0 of 349 (0%)	0 of 349
SilverCloud App + Standard Feedback	0 of 345 (0%)	0 of 345 (0%)	0 of 345
SilverCloud App +Enhanced Feedback +Standard Feedback	0 of 346 (0%)	0 of 346 (0%)	0 of 346

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 39023893Horwitz AG, Mills ED, Sen S, Bohnert ASB. Comparative Effectiveness of Three Digital Interventions for Adults Seeking Psychiatric Services: A Randomized Clinical Trial. JAMA Netw Open. 2024 Jul 1;7(7):e2422115. doi: 10.1001/jamanetworkopen.2024.22115.
Individual participant dataSharing planned: No

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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. This study is not recruiting at the moment.

Amy Bohnert principal investigator

University of Michigan

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 6 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: finished, as of the sponsor's last update on 17 Mar 2025. 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?

Yes. Results are posted in the registry (first posted 17 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change in Depression as Measured by the Patient Health Questionnaire 9 (PHQ-9) (time frame: Up to 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04342494, which also lists 1 linked publication.

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 17 Mar 2025.