Graded Exposure and Mindfulness Meditation for Patients Post-ACL Reconstruction

Part of paid clinical trials in Chapel Hill, North Carolina.

Sponsor
University of North Carolina, Chapel Hill
Study ID
NCT05949177
Status
Recruiting
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Conditions

  • Anterior Cruciate Ligament Injuries

Eligibility Criteria

Sex
ALL
Age
14 Years - 35 Years
Healthy Volunteers
Not accepted

Interventions

  • Graded Exposure and Mindfulness Meditation — BEHAVIORAL
    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 — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Oct 30, 2024
Status verified
Nov 2025
Primary completion
Jul 31, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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.
  • Placebo Comparator: 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 Measure

Change in Task Specific Fears [ Time Frame: Collected at baseline and post-treatment after completion of the intervention or waitlist control at week 5 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Woollen Gymnasium, 300 South RoadChapel HillNorth Carolina27514
Shelby E Baez, Ph.D.., ATC
[email protected]
919-445-1500

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By research site
Woollen Gymnasium, 300 South Road· Chapel Hill, NC

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