Providing Mental Health Precision Treatment

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2118 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-13

Study Completion Date

2023-02-22

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Depression Addiction Anxiety Sleep Disturbance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Enhanced Feedback + Standard Feedback

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

Group Type EXPERIMENTAL

Enhanced Feedback + Standard Feedback

Intervention Type BEHAVIORAL

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 app + Standard Feedback

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

Group Type EXPERIMENTAL

Headspace app + Standard Feedback

Intervention Type DEVICE

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.

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.

Group Type EXPERIMENTAL

Headspace app + Enhanced Feedback + Standard Feedback

Intervention Type DEVICE

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.

SilverCloud app + Standard Feedback

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

Group Type EXPERIMENTAL

SilverCloud + Standard Feedback

Intervention Type DEVICE

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.

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.

Group Type EXPERIMENTAL

SilverCloud app +Enhanced Feedback +Standard Feedback

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No