Graded Exposure and Mindfulness Meditation for Patients Post-ACL Reconstruction

Anterior Cruciate Ligament Injuries Clinical Trial

Official title:

The GEMM Trial: Graded Exposure and Mindfulness Meditation for Patients Post- ACL Reconstruction

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05949177
• Other study ID #: 23-1412
• Secondary ID: 2223GP01
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 15, 2024
• Est. completion date: July 31, 2026

Study information

• Verified date: July 2023
• Source: University of North Carolina, Chapel Hill
• Contact: Shelby E Baez, Ph.D., ATC
• Phone: 919-445-1500
• Email: sbaez[@]unc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: July 31, 2026
• Est. primary completion date: July 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Injuries

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Fetzer Hall, 210 South Road	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	National Athletic Trainers' Association Research & Education Foundation (NATA Foundation)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Task Specific Fears	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."	Collected at baseline and post-treatment after completion of the intervention or waitlist control at week 5
Primary	Change in Overall Injury-Related Fear	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.	Collected at baseline and post-treatment after completion of the intervention or waitlist control at week 5
Secondary	Change in Reinjury Anxiety	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	Collected at baseline and post-treatment after completion of the intervention or waitlist control at week 5
Secondary	Change in Lower Extremity Reaction Time	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).	Collected at baseline and post-treatment after completion of the intervention or waitlist control at week 5