Providing Mental Health Precision Treatment

University of Michigan2,118 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

2,118

Conditions

Depression Addiction Anxiety Sleep Disturbance

Interventions

Enhanced Feedback + Standard FeedbackBEHAVIORAL

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 FeedbackDEVICE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

University of Michigan

Ann Arbor, Michigan, United States

Outcomes

Primary Outcomes

Change in Depression as Measured by the Patient Health Questionnaire 9 (PHQ-9)

The PHQ-9 was a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression. The PHQ-9 incorporated self-report questions on 9 specific depression symptoms that align with the DSM-IV depression diagnostic criteria. PHQ-9 scores ranged from 0-27, with 0 indicating no depression and 27 indicating severe depression.

Time frame: Up to 6 weeks

Secondary Outcomes

Mood as Measured by the Mental Health App Assessment

Participants were asked a single question, "On a scale of 1 to 10, what was your average mood today?" Scores were averaged over follow-up periods with lower scores indicating worse moods and higher scores indicating better moods.

Time frame: Daily up to 6 weeks

Change in Suicide Risk as Measured by the Positive and Negative Suicide Ideation Inventory - Positive Ideation (PANSI-PI)

The PANSI-PI subscale consisted of 6 items. The possible total scores on the PANSI-PI subscale ranged from 6 to 30. Lower scores on the PANSI-PI reflected greater risk for suicidal behavior.

Time frame: Up to 6 weeks

Change in Suicide Risk as Measured by the Positive and Negative Suicide Ideation Inventory - Negative Suicide Ideation (PANSI-NSI)

The PANSI-NSI subscale was composed of 8 items. The possible total score on the PANSI-NSI ranged from 8 to 40. Higher scores on the PANSI-NSI reflected greater risk for suicidal behavior.

Time frame: Up to 6 weeks

Change in Anxiety as Measured Using the Generalized Anxiety Disorder 7-Item (GAD-7) Scale

GAD-7 consisted of the total score for seven items ranging from 0 to 21. Scores of 5, 10, and 15 represented cut points for mild, moderate, and severe anxiety, respectively.

Data from ClinicalTrials.gov

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