MedPath

Providing Mental Health Precision Treatment

Not Applicable
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

Not available

Recruitment & Eligibility

Status
ENROLLING_BY_INVITATION
Sex
All
Target Recruitment
4500
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)
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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)
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Enhanced Feedback + Standard FeedbackEnhanced Feedback + Standard FeedbackParticipants will receive enhanced feedback from the MyDataHelps study app in addition to standard feedback from the activity tracker.
Headspace app + Standard FeedbackHeadspace app + Standard FeedbackParticipants will receive an app-based intervention in addition to standard feedback from the activity tracker.
Headspace app + Enhanced Feedback + Standard FeedbackHeadspace app + Enhanced Feedback + Standard FeedbackParticipants will receive an app-based intervention, enhanced feedback from the MyDataHelps study app, and standard feedback activity tracker.
SilverCloud app + Standard FeedbackSilverCloud + Standard FeedbackParticipants will receive an app-based intervention in addition to standard feedback from the activity tracker.
SilverCloud app +Enhanced Feedback +Standard FeedbackSilverCloud app +Enhanced Feedback +Standard FeedbackParticipants will receive an app-based intervention, enhanced feedback from the MyDataHelps study app, and standard feedback from the activity tracker.
Primary Outcome Measures
NameTimeMethod
Depression as measured by the Patient Health Questionnaire 9(PHQ-9)Up to 12 months

The PHQ-9 is a multipurpose 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.

Secondary Outcome Measures
NameTimeMethod
Mood as measured by the Mental Health App AssessmentDaily up to about 12 months

Single Question, "On a scale of 1 to 10, what was your average mood today?" Scores will be averaged over follow-up periods with lower scores indicating worse moods and higher scores indicating better moods.

Suicide risk as measured by the Positive and Negative Suicide Ideation Inventory (PANSI)Up to 12 months

This is a 14-item subjectively completed inventory that consisted of 2 subscales: the PANSI-NSI subscale composed of 8 items and the Positive Ideation (PANSI-PI) subscale consisting of 6 items. The possible total scores on the PANSI-NSI and PANSI-PI subscales range from 8 to 40 and 6 to 30, respectively. Higher scores on the PANSI-NSI and lower scores on the PANSI-PI reflect greater risk for suicidal behavior.

Anxiety as measured using the Generalized Anxiety Disorder 7-Item (GAD-7) ScaleUp to 12 months

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.

Substance use as measured by the Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST)Up to 12 months

The ASSIST Global Continuum of Illicit Drug Risk Score ranges from 0 to 308, with higher scores indicating greater risk.

Trial Locations

Locations (1)

University of Michigan

🇺🇸

Ann Arbor, Michigan, United States

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