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Behavioral Intervention

Graded Exposure + Mindfulness for ACL Injury

N/A

Waitlist Available

Led By Shelby E Baez, Ph.D., ATC

Research Sponsored by University of North Carolina, Chapel Hill

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up collected at baseline and post-treatment after completion of the intervention or waitlist control at week 5

Awards & highlights

Study Summary

This trial will evaluate if graded exposure and mindfulness meditation help reduce fear and anxiety after ACLR and improve lower extremity reaction time.

Who is the study for?

This trial is for young adults aged 18-25 who had ACL reconstruction surgery 1 to 5 years ago due to a sports-related injury and are experiencing fear related to their injury. It's not for those with multiple ACL injuries, additional surgeries at the time of their ACL repair, or without high levels of injury-related fear.Check my eligibility

What is being tested?

The study tests if graded exposure therapy combined with mindfulness meditation can reduce fear and anxiety about reinjury and improve reaction times in the lower extremity compared to a group that receives no immediate treatment (waitlist control).See study design

What are the potential side effects?

Since this trial involves psychological therapies rather than medication, typical side effects associated with drugs are not expected. Participants may experience emotional discomfort addressing fears.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ collected at baseline and post-treatment after completion of the intervention or waitlist control at week 5

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~collected at baseline and post-treatment after completion of the intervention or waitlist control at week 5

This trial's timeline: 3 weeks for screening, Varies for treatment, and collected at baseline and post-treatment after completion of the intervention or waitlist control at week 5 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Overall Injury-Related Fear

Change in Task Specific Fears

Secondary outcome measures

Change in Lower Extremity Reaction Time

Change in Reinjury Anxiety

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Graded Exposure and Mindfulness MeditationExperimental Treatment1 Intervention

The participants randomized to the GEMM group will complete 1) written exposure and 2) in vivo exposure and will be asked to rate their task specific fears after baseline tests. Tasks identified to be fearful will be used to develop the graded-hierarchy of fearful situations, and these fearful situations will be addressed in the GEMM. Participants will be instructed to watch a 30-min video that provides education on the rationale of cognitive behavioral therapies, specifically the benefits of exposure therapy and mindfulness meditation. Participants randomized into the GEMM group will also complete 5-weeks of Mobile Mindfulness Meditation. Participants randomized into the GEMM group will be guided through 4, 10-minute Mobile Mindfulness Meditation per week (20 total sessions) via the Headspace mobile application where they will learn the fundamentals of mindfulness meditation and how to apply mindfulness meditation to sports rehabilitation.

Group II: Waitlist ControlPlacebo Group1 Intervention

Participants will be randomized to a waitlist control group. Participants will receive an email stating that they will receive access to 5-weeks of Headspace after 5-weeks. Participants will be also asked to not change their normal routines or download apps for relaxation, meditation, or sleep during 5-weeks. After completion of the outcome assessments at 5-weeks, participants in this group will receive access to 5-weeks of Headspace.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

University of North Carolina, Chapel HillLead Sponsor

1,504 Previous Clinical Trials

4,187,612 Total Patients Enrolled

2 Trials studying Anterior Cruciate Ligament Injury

177 Patients Enrolled for Anterior Cruciate Ligament Injury

National Athletic Trainers' Association Research & Education Foundation (NATA Foundation)OTHER

6 Previous Clinical Trials

531 Total Patients Enrolled

1 Trials studying Anterior Cruciate Ligament Injury

Shelby E Baez, Ph.D., ATCPrincipal InvestigatorUNC-Chapel Hill

1 Previous Clinical Trials

48 Total Patients Enrolled

1 Trials studying Anterior Cruciate Ligament Injury

48 Patients Enrolled for Anterior Cruciate Ligament Injury

Media Library

Graded Exposure and Mindfulness Meditation (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05949177 — N/A

Anterior Cruciate Ligament Injury Research Study Groups: Graded Exposure and Mindfulness Meditation, Waitlist Control

Anterior Cruciate Ligament Injury Clinical Trial 2023: Graded Exposure and Mindfulness Meditation Highlights & Side Effects. Trial Name: NCT05949177 — N/A

Graded Exposure and Mindfulness Meditation (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05949177 — N/A

Frequently Asked Questions

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

Is enrollment currently available for this clinical inquiry?

"Eligibility for this trial requires individuals to have suffered an anterior cruciate ligament injury and be between 18-25 years of age. The study is aiming to recruit 50 participants in total."

Answered by AI

Does the age limit for participation in this trial exceed forty-five years of age?

"Individuals aged 18 to 25 may be eligible for this study. Additionally, there are separate trials open to those below the age of 18 and above 65 years old; 50 and 26 respectively."

Answered by AI

Is this research endeavor currently admitting participants?

"According to the information on the clinicaltrials.gov website, recruitment for this particular trial is not active at present. It was initially posted in August 1st 2023 and its last update occured on July 14th of that same year. Nonetheless, there are presently 101 other trials that remain open for enrollment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Graded Exposure and Mindfulness Meditation for Patients Post-ACL Reconstruction

2024. "Graded Exposure and Mindfulness Meditation for Patients Post-ACL Reconstruction". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05949177.