Providing Mental Health Precision Treatment

Not Applicable

Completed

Conditions: Addiction
Depression
Sleep Disturbance
Anxiety

Interventions: Behavioral: Enhanced Feedback + Standard Feedback
Device: Headspace app + Standard Feedback
Device: Headspace app + Enhanced Feedback + Standard Feedback
Device: SilverCloud + Standard Feedback
Device: SilverCloud app +Enhanced Feedback +Standard Feedback

Registration Number: NCT04342494

Lead Sponsor: University of Michigan

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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 2118

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Enhanced Feedback + Standard Feedback	Enhanced Feedback + Standard Feedback	Participants will receive enhanced feedback from the MyDataHelps study app in addition to standard feedback from the activity tracker.
Headspace app + Standard Feedback	Headspace app + Standard Feedback	Participants will receive an app-based intervention in addition to standard feedback from the activity tracker.
Headspace app + Enhanced Feedback + Standard Feedback	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.
SilverCloud app + Standard Feedback	SilverCloud + Standard Feedback	Participants will receive an app-based intervention in addition to standard feedback from the activity tracker.
SilverCloud app +Enhanced Feedback +Standard Feedback	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.

Primary Outcome Measures

Name	Time	Method
Change in Depression as Measured by the Patient Health Questionnaire 9 (PHQ-9)	Up to 6 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Mood as Measured by the Mental Health App Assessment	Daily up to 6 weeks	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.
Change in Suicide Risk as Measured by the Positive and Negative Suicide Ideation Inventory - Positive Ideation (PANSI-PI)	Up to 6 weeks	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.
Change in Suicide Risk as Measured by the Positive and Negative Suicide Ideation Inventory - Negative Suicide Ideation (PANSI-NSI)	Up to 6 weeks	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.
Change in Anxiety as Measured Using the Generalized Anxiety Disorder 7-Item (GAD-7) Scale	Up to 6 weeks	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.
Substance Use as Measured by the Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST)	Up to 6 weeks	The ASSIST Global Continuum of Illicit Drug Risk Score ranged from 0 to 308, with higher scores indicating greater risk. Results reflect the participants who indicated they had consumed any alcohol, smoked, or used an illicit substance when asked.