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Behavioural Intervention
Exercise for Adolescent Anxiety (BRAINS Trial)
N/A
Recruiting
Research Sponsored by Wayne State University
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 throughout study completion (3 days)
Awards & highlights
No Placebo-Only Group
Summary
"This trial aims to test if exercise can improve fear regulation in adolescents with anxiety by enhancing brain activity and endocannabinoid signaling. The hope is that this research will lead to better treatments for adolescent anxiety
Who is the study for?
This trial is for adolescents who may be experiencing anxiety, as it explores how exercise can impact fear regulation. Specific eligibility criteria are not provided, but typically participants would need to be in good health and able to perform moderate intensity exercise.
What is being tested?
The study investigates whether moderate intensity exercise can improve the ability of adolescents to regulate fear by enhancing brain activity and endocannabinoid signaling, which could lead to better treatments for anxiety.
What are the potential side effects?
Since the intervention involves moderate intensity exercise, potential side effects might include typical reactions such as muscle soreness, fatigue or shortness of breath. However, these are generally mild and temporary.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ throughout study completion (3 days)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~throughout study completion (3 days)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Endocannabinoid (eCB) Concentrations
Fear extinction neural circuitry: Functional activation and coupling
Skin Conductance Responding (SCR)
+1 moreSecondary study objectives
Amygdala response during extinction recall
Approach/Avoidance Behavior
Fear Ratings
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Moderate Intensity ExerciseExperimental Treatment1 Intervention
Group II: Control (Coloring)Active Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Moderate Intensity Exercise
2019
Completed Phase 4
~150
Find a Location
Who is running the clinical trial?
National Institute of Mental Health (NIMH)NIH
2,936 Previous Clinical Trials
2,751,467 Total Patients Enrolled
1 Trials studying Adolescence
480 Patients Enrolled for Adolescence
Wayne State UniversityLead Sponsor
315 Previous Clinical Trials
110,763 Total Patients Enrolled