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Behavioural Intervention

Moderate Intensity Exercise for Adolescence (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

BRAINS Trial 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.Check my eligibility
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.See study design
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.

BRAINS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~throughout study completion (3 days)
This trial's timeline: 3 weeks for screening, Varies for treatment, and throughout study completion (3 days) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Endocannabinoid (eCB) Concentrations
Fear extinction neural circuitry: Functional activation and coupling
Skin Conductance Responding (SCR)
+1 more
Secondary outcome measures
Amygdala response during extinction recall
Approach/Avoidance Behavior
Fear Ratings

BRAINS 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
~120

Find a Location

Who is running the clinical trial?

National Institute of Mental Health (NIMH)NIH
2,786 Previous Clinical Trials
2,689,535 Total Patients Enrolled
1 Trials studying Adolescence
480 Patients Enrolled for Adolescence
Wayne State UniversityLead Sponsor
309 Previous Clinical Trials
109,101 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there an age restriction for potential participants under 75 years old in this study?

"Individuals aged between 14 and 17 years old are eligible for participation according to the trial's inclusion criteria."

Answered by AI

Which individuals meet the criteria for participation in this medical study?

"To be eligible for participation, individuals must be in their teenage years, ranging from 14 to 17. The study aims to enroll a total of 174 volunteers."

Answered by AI

Is the enrollment process currently open for this research study?

"As per clinicaltrials.gov, this study is actively seeking participants. It was initially listed on 3/1/2024 and most recently revised on 3/5/2024."

Answered by AI

What is the upper limit of participants enrolled in this clinical investigation?

"Indeed, the details on clinicaltrials.gov suggest that this research endeavor is currently seeking suitable candidates. The trial was originally posted on March 1st, 2024 and underwent its latest revision on March 5th, 2024. It aims to enroll a total of 174 participants within one designated site."

Answered by AI
~116 spots leftby Apr 2028