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Mobile Health Interventions for Mental Health Support (PROMPT Trial)
N/A
Waitlist Available
Led By Amy Bohnert
Research Sponsored by University of Michigan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months
Awards & highlights
PROMPT Trial Summary
This trial is testing if mobile health interventions help patients waiting for mental health treatments, and which patients benefit the most.
Who is the study for?
This trial is for individuals with a mental health appointment at Michigan Medicine or University Health Service, who have daily access to a compatible smartphone. Participants must understand English, provide contact info, agree to be contacted by the study team, and maintain required app settings on their device.Check my eligibility
What is being tested?
The study tests if mobile apps like Headspace and SilverCloud combined with enhanced feedback improve mental health while patients await in-clinic treatment. It also seeks to identify which patients benefit most from these mobile interventions.See study design
What are the potential side effects?
While not explicitly stated, potential side effects may include increased screen time leading to eye strain or sleep disturbances. Users might experience frustration if technical issues occur or anxiety about tracking personal data.
PROMPT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Mental Depression
Secondary outcome measures
Anxiety as measured using the Generalized Anxiety Disorder 7-Item (GAD-7) Scale
Mood as measured by the Mental Health App Assessment
Substance use as measured by the Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST)
+1 morePROMPT Trial Design
5Treatment groups
Experimental Treatment
Group I: SilverCloud app +Enhanced Feedback +Standard FeedbackExperimental Treatment1 Intervention
Participants will receive an app-based intervention, enhanced feedback from the MyDataHelps study app, and standard feedback from the activity tracker.
Group II: SilverCloud app + Standard FeedbackExperimental Treatment1 Intervention
Participants will receive an app-based intervention in addition to standard feedback from the activity tracker.
Group III: Headspace app + Standard FeedbackExperimental Treatment1 Intervention
Participants will receive an app-based intervention in addition to standard feedback from the activity tracker.
Group IV: Headspace app + Enhanced Feedback + Standard FeedbackExperimental Treatment1 Intervention
Participants will receive an app-based intervention, enhanced feedback from the MyDataHelps study app, and standard feedback activity tracker.
Group V: Enhanced Feedback + Standard FeedbackExperimental Treatment1 Intervention
Participants will receive enhanced feedback from the MyDataHelps study app in addition to standard feedback from the activity tracker.
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Who is running the clinical trial?
University of MichiganLead Sponsor
1,796 Previous Clinical Trials
6,373,482 Total Patients Enrolled
67 Trials studying Depression
64,623 Patients Enrolled for Depression
Amy BohnertPrincipal InvestigatorUniversity of Michigan
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Eligibility Criteria:
This trial includes the following eligibility criteria:- Your wrist size does not comfortably fit an Apple Watch or Fitbit, but special bands can be provided to help with this.My mental health appointment is for pediatric care, even though I am 18 or older.You currently have an eating disorder, as reported by yourself or in your medical records.
Research Study Groups:
This trial has the following groups:- Group 1: Headspace app + Enhanced Feedback + Standard Feedback
- Group 2: Enhanced Feedback + Standard Feedback
- Group 3: Headspace app + Standard Feedback
- Group 4: SilverCloud app + Standard Feedback
- Group 5: SilverCloud app +Enhanced Feedback +Standard Feedback
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are any new volunteers being accepted for this experiment?
"As reported on clinicaltrials.gov, this trial is not presently recruiting candidates. Initially posted on May 13th 2020 and most recently modified on December 7th 2021, it is no longer seeking patients; however 1467 other studies are currently searching for participants."
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