NCT04342494

Providing Mental Health Precision Treatment

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,118 (actual)
• Sponsor: University of Michigan · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Depression
• Addiction
• Anxiety
• Sleep Disturbance

Interventions

Type	Name	Description
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.
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.
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.
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.
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.

Timeline

• Start date: 2020-05-13
• Primary completion: 2023-02-22
• Completion: 2023-02-22
• First posted: 2020-04-13
• Last updated: 2025-03-17
• Results posted: 2025-03-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study