Clinical trial NCT04342494: Providing Mental Health Precision Treatment
Official title: Providing Mental Health Precision Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Addiction
Anxiety
Sleep Disturbance
Keywords: Behavioral health
Precision health
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2020-04-13
Enrollment: 2118
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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)

Primary outcomes:
measure: Change in Depression as Measured by the Patient Health Questionnaire 9 (PHQ-9)
timeFrame: Up to 6 weeks
Secondary outcomes:
measure: Mood as Measured by the Mental Health App Assessment
timeFrame: Daily up to 6 weeks
measure: Change in Suicide Risk as Measured by the Positive and Negative Suicide Ideation Inventory - Positive Ideation (PANSI-PI)
timeFrame: Up to 6 weeks
measure: Change in Suicide Risk as Measured by the Positive and Negative Suicide Ideation Inventory - Negative Suicide Ideation (PANSI-NSI)
timeFrame: Up to 6 weeks
measure: Change in Anxiety as Measured Using the Generalized Anxiety Disorder 7-Item (GAD-7) Scale
timeFrame: Up to 6 weeks
measure: Substance Use as Measured by the Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST)
timeFrame: Up to 6 weeks
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Amy Bohnert
role: PRINCIPAL_INVESTIGATOR
References: