Providing Mental Health Precision Treatment (PROMPT)

April 19, 2023 updated by: Amy S.B. Bohnert, University of Michigan
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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

4500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Enhanced Feedback + Standard Feedback
Participants will receive enhanced feedback from the MyDataHelps study app in addition to standard feedback from the activity tracker.
Behavioral: Enhanced Feedback + Standard 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.

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

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.
Experimental: SilverCloud app + Standard Feedback
Participants will receive an app-based intervention in addition to standard feedback from the activity tracker.
Device: SilverCloud + Standard 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.

Silvercloud is an app designed to deliver cognitive behavioral therapy.
Experimental: SilverCloud app +Enhanced Feedback +Standard Feedback
Participants will receive an app-based intervention, enhanced feedback from the MyDataHelps study app, and standard feedback from the activity tracker.
Device: SilverCloud app +Enhanced Feedback +Standard 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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Depression as measured by the Patient Health Questionnaire 9(PHQ-9)
Time Frame: Up to 12 months
The PHQ-9 is a multipurpose 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.
Up to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mood as measured by the Mental Health App Assessment
Time Frame: Daily up to about 12 months
Single Question, "On a scale of 1 to 10, what was your average mood today?" Scores will be averaged over follow-up periods with lower scores indicating worse moods and higher scores indicating better moods.
Daily up to about 12 months
Suicide risk as measured by the Positive and Negative Suicide Ideation Inventory (PANSI)
Time Frame: Up to 12 months
This is a 14-item subjectively completed inventory that consisted of 2 subscales: the PANSI-NSI subscale composed of 8 items and the Positive Ideation (PANSI-PI) subscale consisting of 6 items. The possible total scores on the PANSI-NSI and PANSI-PI subscales range from 8 to 40 and 6 to 30, respectively. Higher scores on the PANSI-NSI and lower scores on the PANSI-PI reflect greater risk for suicidal behavior.
Up to 12 months
Anxiety as measured using the Generalized Anxiety Disorder 7-Item (GAD-7) Scale
Time Frame: Up to 12 months
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.
Up to 12 months
Substance use as measured by the Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST)
Time Frame: Up to 12 months
The ASSIST Global Continuum of Illicit Drug Risk Score ranges from 0 to 308, with higher scores indicating greater risk.
Up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Investigators

  • Principal Investigator: Amy Bohnert, University of Michigan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 13, 2020

Primary Completion (Anticipated)

July 1, 2024

Study Completion (Anticipated)

July 1, 2024

Study Registration Dates

First Submitted

April 8, 2020

First Submitted That Met QC Criteria

April 8, 2020

First Posted (Actual)

April 13, 2020

Study Record Updates

Last Update Posted (Actual)

April 21, 2023

Last Update Submitted That Met QC Criteria

April 19, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUM00164162

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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