Graded exposure and mindfulness meditation for patients recovering from ACL reconstruction
The GEMM Trial: Graded Exposure and Mindfulness Meditation for Patients Post- ACL Reconstruction
This study is testing if a combination of mindfulness meditation and graded exposure can help young adults who have had ACL surgery feel less anxious and improve their reaction time during recovery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 14 Years to 35 Years |
| Sex | All |
| Sponsor | University of North Carolina, Chapel Hill Academic / other |
| Locations | 1 site (Chapel Hill, North Carolina) |
| Trial ID | NCT05949177 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of a combined approach of graded exposure and mindfulness meditation in reducing injury-related fear and anxiety, as well as improving reaction time in individuals who have undergone anterior cruciate ligament reconstruction (ACLR). Participants aged 18-25 years, who are 1 to 5 years post-ACLR, will be randomized into either the intervention group receiving the GEMM program or a waitlist control group. The intervention will be delivered through the Headspace application over a 5-week period, with assessments conducted before and after the intervention to measure outcomes related to fear, anxiety, and reaction time. The study aims to provide insights into the feasibility and efficacy of integrating mindfulness practices into rehabilitation for ACL injuries.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 18-25 years who have undergone unilateral ACL reconstruction and report elevated levels of injury-related fear.
Not a fit: Patients with a history of secondary ACL injury or those who do not exhibit elevated injury-related fear may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce fear and anxiety related to reinjury, enhancing recovery and performance for young athletes post-ACLR.
How similar studies have performed: While graded exposure and mindfulness meditation have shown promise individually, this combined approach has not been extensively tested in the context of ACL rehabilitation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Ages 14-35 years * Have self-reported levels of fear on the Tampa Scale of Kinesiophobia-11 and the Photographic Series of Sports Activities for ACLR * Injured their knee playing or training for sports (recreational or organized) * Have a history of unilateral ACLR * 6 months to 10-years post-ACLR Exclusion Criteria: * History of secondary ACL injury * Do not exhibit elevated injury-related fear * Concomitant surgeries at the time of ACL reconstruction
Where this trial is running
Chapel Hill, North Carolina
- Woollen Gymnasium, 300 South Road — Chapel Hill, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Shelby E Baez, Ph.D., ATC — UNC-Chapel Hill
- Study coordinator: Shelby E Baez, Ph.D., ATC
- Email: sbaez@unc.edu
- Phone: 919-445-1500
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.