Providing Mental Health Precision Treatment

Depression Clinical Trial

— PROMPT  

Official title:

Providing Mental Health Precision Treatment

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04342494
• Other study ID #: HUM00164162
• Status: Enrolling by invitation
• Phase: N/A
• Start date: May 13, 2020
• Est. completion date: July 2024

Study information

• Verified date: April 2023
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 4500
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Addiction
• Anxiety
• Depression
• Dyssomnias
• Parasomnias
• Sleep Disturbance

Intervention

Behavioral:
• Enhanced Feedback + Standard Feedback
Standard Feedback (SF) All participants will receive the standard feedback that is standard feedback from the activity trackers. Feedback includes activity level, heart rate, and progress toward daily activity goals on the device itself. Enhanced Feedback (EF) 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. Feedback 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 feedback.

Device:
• Headspace app + Standard Feedback
Standard Feedback (SF) All participants will receive the standard feedback that is standard feedback from the activity trackers. Feedback includes activity level, heart rate, and progress toward daily activity goals on the device itself. Headspace is an app designed to train the user in mindfulness practices.
• Headspace app + Enhanced Feedback + Standard Feedback
Standard Feedback (SF) All participants will receive the standard feedback that is standard feedback from the activity trackers. Feedback includes activity level, heart rate, and progress toward daily activity goals on the device itself. Enhanced Feedback (EF) 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. Feedback 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 feedback. Headspace is an app designed to train the user in mindfulness practices.
• SilverCloud + Standard Feedback
Standard Feedback (SF) All participants will receive the standard feedback that is standard feedback from the activity trackers. Feedback includes activity level, heart rate, and progress toward daily activity goals on the device itself. Silvercloud is an app designed to deliver cognitive behavioral therapy.
• SilverCloud app +Enhanced Feedback +Standard Feedback
Standard Feedback (SF) All participants will receive the standard feedback that is standard feedback from the activity trackers. Feedback includes activity level, heart rate, and progress toward daily activity goals on the device itself. Enhanced Feedback (EF) 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. Feedback 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 feedback. Silvercloud is an app designed to deliver cognitive behavioral therapy.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depression as measured by the Patient Health Questionnaire 9(PHQ-9)	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.	Up to 12 months
Secondary	Mood as measured by the Mental Health App Assessment	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.	Daily up to about 12 months
Secondary	Suicide risk as measured by the Positive and Negative Suicide Ideation Inventory (PANSI)	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.	Up to 12 months
Secondary	Anxiety as measured using the Generalized Anxiety Disorder 7-Item (GAD-7) Scale	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.	Up to 12 months
Secondary	Substance use as measured by the Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST)	The ASSIST Global Continuum of Illicit Drug Risk Score ranges from 0 to 308, with higher scores indicating greater risk.	Up to 12 months