Graded Exposure and Mindfulness Meditation for ACL Reconstruction Recovery

This study is looking at whether a combination of Graded Exposure (gradually facing fear-inducing situations) and Mindfulness Meditation (guided through the Headspace app) can help people who have had ACL (anterior cruciate ligament) reconstruction surgery. The goal is to reduce fear related to their injury and improve their reaction time. You might be able to join if you are 14-35 years old, had ACL surgery 6 months to 10 years ago, and still experience fear related to your knee injury. The study aims to see if this approach can decrease your fear and anxiety and make your reaction time faster compared to a group that waits to receive the Headspace app. The current recruitment status is unclear.

Study design
This is an interventional study planning to enroll 50 participants. You would be randomly assigned to either the Graded Exposure and Mindfulness Meditation group or a waitlist control group.
What's involved
If you are in the Graded Exposure and Mindfulness Meditation group, you will complete graded exposure once a week and use the Headspace app for mindfulness meditation for 5 weeks. If you are in the waitlist control group, you will be asked not to change your normal routines or download relaxation apps for 5 weeks.
Compensation
Not stated in the trial record.
Follow-up
Your fear levels and reaction time will be measured at the beginning and after 5 weeks, at the end of the intervention or waitlist period.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05949177

Graded Exposure and Mindfulness Meditation for Patients Post-ACL Reconstruction

Recruiting
NAAges 14–35InterventionalTreatment
University of North Carolina, Chapel Hill
~50 participants
Updated 2025-11-13 on ClinicalTrials.gov
What's tested:Graded Exposure and Mindfulness MeditationWaitlist Control

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Task Specific Fears
Measured over Collected at baseline and post-treatment after completion of the intervention or waitlist control at week 5
+1 more outcome measured
Anterior Cruciate Ligament Injuries

NCT05949177

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Woollen Gymnasium, 300 South Road

    Chapel Hill, North Carolinastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

  • Shelby E Baez, Ph.D., ATC · PRINCIPAL_INVESTIGATOR · UNC-Chapel Hill

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Eligibility criteria

Inclusion

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

History of secondary ACL injury
Do not exhibit elevated injury-related fear
Concomitant surgeries at the time of ACL reconstruction
  • Change in Task Specific FearsCollected at baseline and post-treatment after completion of the intervention or waitlist control at week 5

    The Photographic Series of Sports Activities for ACLR is a patient-reported outcome designed to measure fear of harm of specific tasks through photographical assessment. Patients will be instructed to rate each photograph of sports activities on a scale of 0 to 10, with 0 representing "not harmful at all" and 10 representing "extremely harmful."

  • Change in Overall Injury-Related FearCollected at baseline and post-treatment after completion of the intervention or waitlist control at week 5

    The Tampa Scale of Kinesiophobia-11 is a valid and reliable questionnaire that consists of 11-items and evaluates fear of movement and re-injury. A 4-point Likert scale is used to score each item. Scores range from 11-44 with higher scores representing higher kinesiophobia. AIM 1: Determine the efficacy of GEMM compared to a waitlist control group to decrease injury-related fear and reinjury anxiety in participants with a history of ACLR 1-5 years post-reconstruction.