Providing Mental Health Precision Treatment (PROMPT)

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)

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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