NCT05949177 · University of North Carolina, Chapel Hill
Graded Exposure and Mindfulness Meditation for Patients Post-ACL Reconstruction
What this study is about
To evaluate the effect of graded exposure and mindfulness meditation after ACLR, the investigators will determine the effect of graded exposure and mindfulness meditation to 1) decrease self-reported injury-related fear and reinjury anxiety, and 2) improve lower extremity reaction time when compared to a waitlist control group.
View original scientific description
To evaluate the effect of graded exposure and mindfulness meditation after ACLR, the investigators will determine the effect of graded exposure and mindfulness meditation to 1) decrease self-reported injury-related fear and reinjury anxiety, and 2) improve lower extremity reaction time when compared to a waitlist control group.
Interventions
BEHAVIORAL
Graded Exposure and Mindfulness Meditation
Participants will complete graded exposure and will be encouraged to face fear-eliciting situations. Participants will also complete mindfulness meditation guided through the Headspace mobile application. Participants will complete the graded exposure one time per week and will complete the mindfulness meditation 4 times per week.
BEHAVIORAL
Waitlist Control
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.
Primary outcome measures
Change in Task Specific Fears
Time frame: Collected 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 Fear
Time frame: Collected 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Chapel Hill, North Carolina
Collaborators
National Athletic Trainers' Association Research & Education Foundation (NATA Foundation)
Related conditions & keywords
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Data: ClinicalTrials.gov · synced Nov 13, 2025 · Source of record for eligibility and locations