Clinical trial NCT05949177: Graded Exposure and Mindfulness Meditation for Patients Post-ACL Reconstruction
Official title: The GEMM Trial: Graded Exposure and Mindfulness Meditation for Patients Post- ACL Reconstruction
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anterior Cruciate Ligament Injuries
Keywords: Rehabilitation
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Athletic Trainers' Association Research & Education Foundation (NATA Foundation)
First posted: 2023-07-17
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Injury-related fear after anterior cruciate ligament reconstruction (ACLR) is associated with secondary ACL injury and slower reaction time. Graded exposure (GE) and mindfulness meditation (MM) have reduced injury-related fear, but has not been explored together in patients post-ACLR. GE and MM delivered via the Headspace application is feasible for individuals post-ACLR. GEMM allows athletic trainers' to easily implement MM into their practice. The aim of this randomized single-blinded clinical trial is to determine the efficacy of 5-weeks of GEMM to decrease injury-related fear and reinjury anxiety and improve reaction time in participants 1 to 5-years post-ACLR. Participants will be randomized into a GEMM group or waitlist control group. Participants will complete the Photographic Series of Sports Activities for ACLR, Reinjury Anxiety Inventory, the Tampa Scale of Kinesiophobia-11 and a lower extremity reaction time task pre and post the 5-week period. The investigators hypothesize that participants in the GEMM group will exhibit decreased injury-related fear and reinjury anxiety and faster reaction time when compared to the waitlist controls.

Eligibility criteria: Inclusion Criteria:

* Ages 18-25 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
* 1 to 5-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

Primary outcomes:
measure: Change in Task Specific Fears
timeFrame: Collected at baseline and post-treatment after completion of the intervention or waitlist control at week 5
measure: Change in Overall Injury-Related Fear
timeFrame: Collected at baseline and post-treatment after completion of the intervention or waitlist control at week 5
Secondary outcomes:
measure: Change in Reinjury Anxiety
timeFrame: Collected at baseline and post-treatment after completion of the intervention or waitlist control at week 5
measure: Change in Lower Extremity Reaction Time
timeFrame: Collected at baseline and post-treatment after completion of the intervention or waitlist control at week 5
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: Woollen Gymnasium, 300 South Road
state: North Carolina
Study officials:
affiliation: UNC-Chapel Hill
name: Shelby E Baez, Ph.D., ATC
role: PRINCIPAL_INVESTIGATOR
References: