Mental Health
Conditions
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.
Interventions
BEHAVIORALMindfulness + Tailored Messages
Tailored Messages (TM) 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. Messages 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 messages. The study will use an app designed to train the user in mindfulness practices.
BEHAVIORALMindfulness without Tailored Messages
The study will use an app designed to train the user in mindfulness practices.
BEHAVIORALCognitive Behavioral Therapy (CBT) + Tailored Messages
Tailored Messages (TM) 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. Messages 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 messages. The study will use an app designed to deliver cognitive behavioral therapy.
BEHAVIORALCognitive Behavioral Therapy (CBT) without Tailored Messages
The study will use an app designed to deliver cognitive behavioral therapy.
Sponsors
University of Michigan
National Institute of Mental Health (NIMH)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Seeking mental health services from Michigan Medicine, University Health Services, or collaborative clinics and services. * 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
Exclusion criteria
* Self-reported or medical record indication of a current eating disorder * Unable to provide informed consent (e.g., cognitive or guardianship restrictions) * Scheduled outpatient mental health appointment is a pediatric appointment (even if age 18+)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Depression as measured by the Patient Health Questionnaire 9(PHQ-9) | From enrollment to the 6-week assessment. | The PHQ-9 is an instrument for screening, diagnosing, monitoring and measuring the severity of depression: The PHQ-9 incorporates self-report questions on 9 specific depression symptoms that align with the DSM-IV depression diagnostic criteria. PHQ-9 scores range from 0-27 and 27 indicates severe depression. |
| Anxiety as measured using the Generalized Anxiety Disorder 7-Item (GAD-7) Scale | From enrollment to the 6-week assessment. | GAD-7 consists total score for the seven items ranges from 0 to 21. Scores of 5, 10, and 15 represent cut points for mild, moderate, and severe anxiety, respectively. |
Countries
United States
Outcome results
None listed