ClinicalTrials.Veeva

Menu

Providing Mental Health Precision Treatment (PROMPT)

University of Michigan logo

University of Michigan

Status

Completed

Conditions

Addiction
Sleep Disturbance
Depression
Anxiety

Treatments

Device: SilverCloud + Standard Feedback
Behavioral: Enhanced Feedback + Standard Feedback
Device: Headspace app + Enhanced Feedback + Standard Feedback
Device: Headspace app + Standard Feedback
Device: SilverCloud app +Enhanced Feedback +Standard Feedback

Study type

Interventional

Funder types

Other

Identifiers

NCT04342494
HUM00164162

Details and patient eligibility

About

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.

Full 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.

Enrollment

2,118 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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)

Exclusion criteria

  • 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 design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

2,118 participants in 5 patient groups

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

Trial documents
1

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems