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Behavioral Intervention
Graded Exposure + Mindfulness for ACL Injury
N/A
Recruiting
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
Summary
This trial tests if gradually facing fears and practicing mindfulness can reduce anxiety and improve reaction times in patients who had ACL surgery. The goal is to help these patients feel less afraid of re-injury and react faster.
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.
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).
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
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Overall Injury-Related Fear
Change in Task Specific Fears
Secondary study objectives
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.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Anterior Cruciate Ligament (ACL) injury, such as Graded Exposure and Mindfulness Meditation, work through different mechanisms to aid recovery. Graded Exposure involves a gradual increase in physical activity to reduce fear and anxiety, helping patients regain confidence and improve functional outcomes by slowly reintroducing them to activities they may avoid due to fear of reinjury.
Mindfulness Meditation focuses on mental practices that enhance focus and reduce stress, aiding in pain management and improving overall mental well-being. These treatments are crucial for ACL injury patients as they address both the physical and psychological aspects of recovery, promoting a more holistic and effective rehabilitation process.
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Who is running the clinical trial?
University of North Carolina, Chapel HillLead Sponsor
1,554 Previous Clinical Trials
4,293,078 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
508 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 18 and 25 years old.I had ACL reconstruction surgery between 1 and 5 years ago.I am having other surgeries along with my ACL repair.I have had surgery to repair one of my ACLs.
Research Study Groups:
This trial has the following groups:- Group 1: Graded Exposure and Mindfulness Meditation
- Group 2: Waitlist Control
Awards:
This trial has 0 awards, including: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.
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