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Providing Mental Health Precision Treatment (PROMPT)

Primary Purpose

Depression, Addiction, Anxiety

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Enhanced Feedback + Standard Feedback
Headspace app + Standard Feedback
Headspace app + Enhanced Feedback + Standard Feedback
SilverCloud + Standard Feedback
SilverCloud app +Enhanced Feedback +Standard Feedback
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Depression focused on measuring Behavioral health, Precision health

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • University of Michigan

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Enhanced Feedback + Standard Feedback

Headspace app + Standard Feedback

Headspace app + Enhanced Feedback + Standard Feedback

SilverCloud app + Standard Feedback

SilverCloud app +Enhanced Feedback +Standard Feedback

Arm Description

Participants will receive enhanced feedback from the MyDataHelps study app in addition to standard feedback from the activity tracker.

Participants will receive an app-based intervention in addition to standard feedback from the activity tracker.

Participants will receive an app-based intervention, enhanced feedback from the MyDataHelps study app, and standard feedback activity tracker.

Participants will receive an app-based intervention in addition to standard feedback from the activity tracker.

Participants will receive an app-based intervention, enhanced feedback from the MyDataHelps study app, and standard feedback from the activity tracker.

Outcomes

Primary Outcome Measures

Depression as measured by the Patient Health Questionnaire 9(PHQ-9)
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.

Secondary Outcome Measures

Mood as measured by the Mental Health App Assessment
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.
Suicide risk as measured by the Positive and Negative Suicide Ideation Inventory (PANSI)
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.
Anxiety as measured using the Generalized Anxiety Disorder 7-Item (GAD-7) Scale
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.
Substance use as measured by the Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST)
The ASSIST Global Continuum of Illicit Drug Risk Score ranges from 0 to 308, with higher scores indicating greater risk.

Full Information

First Posted
April 8, 2020
Last Updated
April 19, 2023
Sponsor
University of Michigan
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1. Study Identification

Unique Protocol Identification Number
NCT04342494
Brief Title
Providing Mental Health Precision Treatment
Acronym
PROMPT
Official Title
Providing Mental Health Precision Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
May 13, 2020 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Addiction, Anxiety, Sleep Disturbance
Keywords
Behavioral health, Precision health

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
4500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Enhanced Feedback + Standard Feedback
Arm Type
Experimental
Arm Description
Participants will receive enhanced feedback from the MyDataHelps study app in addition to standard feedback from the activity tracker.
Arm Title
Headspace app + Standard Feedback
Arm Type
Experimental
Arm Description
Participants will receive an app-based intervention in addition to standard feedback from the activity tracker.
Arm Title
Headspace app + Enhanced Feedback + Standard Feedback
Arm Type
Experimental
Arm Description
Participants will receive an app-based intervention, enhanced feedback from the MyDataHelps study app, and standard feedback activity tracker.
Arm Title
SilverCloud app + Standard Feedback
Arm Type
Experimental
Arm Description
Participants will receive an app-based intervention in addition to standard feedback from the activity tracker.
Arm Title
SilverCloud app +Enhanced Feedback +Standard Feedback
Arm Type
Experimental
Arm Description
Participants will receive an app-based intervention, enhanced feedback from the MyDataHelps study app, and standard feedback from the activity tracker.
Intervention Type
Behavioral
Intervention Name(s)
Enhanced Feedback + Standard Feedback
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Headspace app + Standard Feedback
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Headspace app + Enhanced Feedback + Standard Feedback
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
SilverCloud + Standard Feedback
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
SilverCloud app +Enhanced Feedback +Standard Feedback
Intervention Description
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.
Primary Outcome Measure Information:
Title
Depression as measured by the Patient Health Questionnaire 9(PHQ-9)
Description
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.
Time Frame
Up to 12 months
Secondary Outcome Measure Information:
Title
Mood as measured by the Mental Health App Assessment
Description
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.
Time Frame
Daily up to about 12 months
Title
Suicide risk as measured by the Positive and Negative Suicide Ideation Inventory (PANSI)
Description
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.
Time Frame
Up to 12 months
Title
Anxiety as measured using the Generalized Anxiety Disorder 7-Item (GAD-7) Scale
Description
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.
Time Frame
Up to 12 months
Title
Substance use as measured by the Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST)
Description
The ASSIST Global Continuum of Illicit Drug Risk Score ranges from 0 to 308, with higher scores indicating greater risk.
Time Frame
Up to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amy Bohnert
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Providing Mental Health Precision Treatment

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