N/A
N=2,079
Providing Mental Health Precision Treatment
Depression · Addiction · Anxiety · Sleep Disturbance
Bottom Line
View on ClinicalTrials.gov: NCT04342494 ↗Enrolled (actual)
2,079
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcome: Primary: Change in Depression as Measured by the Patient Health Questionnaire 9 (PHQ-9) — 12.6; 12.5; 13.0; 13.0 score on a scale — p=0.31
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Enhanced Feedback + Standard Feedback (Behavioral); Headspace app + Standard Feedback (Device); Headspace app + Enhanced Feedback + Standard Feedback (Device); SilverCloud + Standard Feedback (Device); SilverCloud app +Enhanced Feedback +Standard Feedback (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Michigan
- Primary completion
- Feb 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Depression as Measured by the Patient Health Questionnaire 9 (PHQ-9) |
12.6; 12.5; 13.0; 13.0; 12.8; 10.1 | 0.31 |
| SECONDARY Mood as Measured by the Mental Health App Assessment |
6.2; 6.1; 6.2; 6.0; 5.9 | 0.0073 sig |
| SECONDARY Change in Suicide Risk as Measured by the Positive and Negative Suicide Ideation Inventory - Positive Ideation (PANSI-PI) |
18.4; 18.4; 17.9; 18.2; 17.8; 19.1 | 0.03 sig |
| SECONDARY Change in Suicide Risk as Measured by the Positive and Negative Suicide Ideation Inventory - Negative Suicide Ideation (PANSI-NSI) |
11.1; 11.0; 12.2; 11.6; 11.7; 9.9 | 0.71 |
| SECONDARY Change in Anxiety as Measured Using the Generalized Anxiety Disorder 7-Item (GAD-7) Scale |
11.5; 11.6; 11.4; 11.9; 11.8; 9.9 | 0.31 |
| SECONDARY Substance Use as Measured by the Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST) |
560; 300; 303; 287; 285; 510 | — |
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.
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)
Data sourced from ClinicalTrials.gov (NCT04342494). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.