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Digital Intervention for Mental Health Diagnosis (GamerFit Trial)
N/A
Waitlist Available
Led By Amanda E Staiano, PhD, MPP
Research Sponsored by Pennington Biomedical Research Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
GamerFit Trial Summary
This trial is testing whether an app that encourages physical activity, gaming, and sleep can help improve symptoms of psychiatric disorders in teens.
Who is the study for?
This trial is for young people aged 13-17 with a psychiatric diagnosis, who are physically able to exercise and have access to a smartphone or tablet. They must understand English or have a translator during coaching sessions, and not have intellectual disabilities that would interfere with participation.Check my eligibility
What is being tested?
The 'GamerFit' study tests an mHealth app designed to boost physical activity, sleep quality, and reduce psychiatric symptoms in youth. Participants will either use the GamerFit app with weekly coaching or a commercial app as comparison. They'll be randomly assigned to one of these two groups.See study design
What are the potential side effects?
Since this intervention involves digital tools and physical activity rather than medication, side effects may include typical risks associated with exercise such as muscle soreness or strain. The digital nature of the intervention might also contribute to increased screen time.
GamerFit Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Feasibility of the app
Secondary outcome measures
Physical activity
Sleep
GamerFit Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: GamerFit ConditionExperimental Treatment1 Intervention
Includes use of a Fitbit and exergaming devices, the GamerFit app, and weekly telehealth coaching sessions.
Group II: Comparator ConditionActive Control1 Intervention
Youth assigned to the comparator condition (n=30-35) will receive a Fitbit device (same as the intervention condition) and the Fitbit account activated on their device (e.g. phone/tablet/computer). They will receive instructions on using the PA and sleep tracking features, as well as a booklet of healthy habit tips. They will receive reminders to charge, sync and review their Fitbit data for the duration of the intervention.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
GamerFit Condition
2023
N/A
~70
Find a Location
Who is running the clinical trial?
Pennington Biomedical Research CenterLead Sponsor
304 Previous Clinical Trials
181,374 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,696 Previous Clinical Trials
6,952,526 Total Patients Enrolled
Merrimack CollegeOTHER
1 Previous Clinical Trials
23 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I can attend telehealth coaching sessions.I am between 13 and 17 years old.I can have a translator with me if I'm not fluent in English.I have been diagnosed with a personality disorder, not including eating disorders, confirmed by my parent.I have an IQ of 85 or higher and no intellectual disability that prevents me from participating.
Research Study Groups:
This trial has the following groups:- Group 1: Comparator Condition
- Group 2: GamerFit Condition
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.
What is the aggregate amount of participants involved in this medical experiment?
"Affirmative, clinicaltrials.gov hosts data indicating that this medical trial is actively recruiting as of October 6th 2022. It was first posted on the 5th of October and requires 60 participants from a single site for completion."
Answered by AI
Is this experiment enrolling new participants?
"Affirmative. As detailed on clinicaltrials.gov, this medical trial, which first appeared online on October 5th 2022, is actively recruiting individuals to partake in the study. 60 participants are required and enrolment is taking place at a single site."
Answered by AI
Are senior citizens accepted as participants for this research endeavor?
"The minimum age for inclusion in this medical trial is 14 years and the maximum age is 17, as per the eligibility criteria."
Answered by AI
Do I meet the prerequisites to partake in this clinical experiment?
"To be involved in this trial, adolescent candidates between 14 and 17 years old must suffer from a mental illness. The research team is hoping to enrol 60 participants."
Answered by AI
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