Providing Mental Health Precision Treatment
PROMPT
1 other identifier
interventional
2,118
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable depression
Started May 2020
Typical duration for not_applicable depression
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 8, 2020
CompletedFirst Posted
Study publicly available on registry
April 13, 2020
CompletedStudy Start
First participant enrolled
May 13, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 22, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
February 22, 2023
CompletedResults Posted
Study results publicly available
March 17, 2025
CompletedMarch 17, 2025
February 1, 2025
2.8 years
April 8, 2020
February 27, 2025
February 27, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Up to 6 weeks
Secondary Outcomes (5)
Mood as Measured by the Mental Health App Assessment
Daily up to 6 weeks
Change in Suicide Risk as Measured by the Positive and Negative Suicide Ideation Inventory - Positive Ideation (PANSI-PI)
Up to 6 weeks
Change in Suicide Risk as Measured by the Positive and Negative Suicide Ideation Inventory - Negative Suicide Ideation (PANSI-NSI)
Up to 6 weeks
Change in Anxiety as Measured Using the Generalized Anxiety Disorder 7-Item (GAD-7) Scale
Up to 6 weeks
Substance Use as Measured by the Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST)
Up to 6 weeks
Study Arms (5)
Enhanced Feedback + Standard Feedback
EXPERIMENTALParticipants will receive enhanced feedback from the MyDataHelps study app in addition to standard feedback from the activity tracker.
Headspace app + Standard Feedback
EXPERIMENTALParticipants will receive an app-based intervention in addition to standard feedback from the activity tracker.
Headspace app + Enhanced Feedback + Standard Feedback
EXPERIMENTALParticipants will receive an app-based intervention, enhanced feedback from the MyDataHelps study app, and standard feedback activity tracker.
SilverCloud app + Standard Feedback
EXPERIMENTALParticipants will receive an app-based intervention in addition to standard feedback from the activity tracker.
SilverCloud app +Enhanced Feedback +Standard Feedback
EXPERIMENTALParticipants will receive an app-based intervention, enhanced feedback from the MyDataHelps study app, and standard feedback from the activity tracker.
Interventions
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.
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.
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- Self-reported or medical record indication of a current eating disorder
- Scheduled outpatient mental health appointment is a pediatric appointment (even if age 18+)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Michigan
Ann Arbor, Michigan, 48109, United States
Related Publications (1)
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.
PMID: 39023893DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Amy Bohnert
- Organization
- University of Michigan
Study Officials
- PRINCIPAL INVESTIGATOR
Amy Bohnert
University of Michigan
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
April 8, 2020
First Posted
April 13, 2020
Study Start
May 13, 2020
Primary Completion
February 22, 2023
Study Completion
February 22, 2023
Last Updated
March 17, 2025
Results First Posted
March 17, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will not share