Graded Exposure and Mindfulness Meditation for Patients Post-ACL Reconstruction

Not Applicable

Recruiting

• Conditions: Anterior Cruciate Ligament Injuries
• Interventions: Behavioral: Graded Exposure and Mindfulness Meditation; Behavioral: Waitlist Control

• Registration Number: NCT05949177
• Lead Sponsor: University of North Carolina, Chapel Hill

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.

Study Timeline

• Study First Submitted: 2023-06-26
• Study First Submitted QC: 2023-07-14
• Study First Posted: 2023-07-17
• Status Verified: 2024-08
• Study Start: 2024-10-30
• Last Update Submitted: 2024-12-04
• Last Update Posted: 2024-12-09
• Primary Completion: 2026-07-31
• Study Completion: 2026-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

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Exclusion Criteria

• History of secondary ACL injury
• Do not exhibit elevated injury-related fear
• Concomitant surgeries at the time of ACL reconstruction

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Graded Exposure and Mindfulness Meditation	Graded Exposure and Mindfulness Meditation	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.
Waitlist Control	Waitlist Control	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.

Primary Outcome Measures

Name	Time	Method
Change in Task Specific Fears	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	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.

Secondary Outcome Measures

Name	Time	Method
Change in Reinjury Anxiety	Collected at baseline and post-treatment after completion of the intervention or waitlist control at week 5	The reinjury anxiety inventory (RIAI) is a valid and reliable 28-item questionnaire of reinjury anxiety which consists of two subscales, rehabilitation reinjury anxiety and reentry into competition reinjury anxiety. A 4-point Likert scale is used to score each item. The RIAI is scored by computing a separate score for the two subscales and adding these scores together for an overall total score. Total score ranges from 0-84 with higher scores representing higher reinjury anxiety
Change in Lower Extremity Reaction Time	Collected at baseline and post-treatment after completion of the intervention or waitlist control at week 5	Participants will complete a standardized and novel lower extremity reaction time assessment using the FitLight Trainer. Participants will be instructed to respond to a visual stimulus and deactivate a series of 5 targets arranged in a semicircle with their feet. The protocol will last for 1 minute and completed bilaterally. Test limb order will be counterbalanced between participants. Participants will complete 3 familiarization trials and 1 test trial per limb (ms).

Trial Locations

Locations (1)

Woollen Gymnasium, 300 South Road; 🇺🇸 Chapel Hill, North Carolina, United States