Graded Exposure and Mindfulness Meditation for Patients Post-ACL Reconstruction

University of North Carolina (UNC)

Status: Enrolling

Conditions: Anterior Cruciate Ligament Injuries

Treatments: Behavioral: Waitlist Control; Behavioral: Graded Exposure and Mindfulness Meditation

Study type: Interventional

Funder types: Other

Identifiers

NCT05949177

2223GP01 (Other Grant/Funding Number)

23-1412

Details and patient eligibility

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 25 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups, including a placebo group

Graded Exposure and Mindfulness Meditation

Experimental group

Description:

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.

Treatment:

Behavioral: Graded Exposure and Mindfulness Meditation

Waitlist Control

Placebo Comparator group

Description:

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.

Treatment:

Behavioral: Waitlist Control