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Recruiting NCT05949177

Graded Exposure and Mindfulness Meditation for Patients Post-ACL Reconstruction

No phase Interventional Anterior Cruciate Ligament Injuries

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Graded Exposure and Mindfulness Meditation, Waitlist Control.
Who it may be relevant to
Registry conditions: Anterior Cruciate Ligament Injuries. Basic parameters: 14 years — 35 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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 6 months to 10-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.

Interventions

  • 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.
  • Behavioral 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.

Primary outcome measures

  • Change in Task Specific Fears [Time frame: Collected at baseline and post-treatment after completion of the intervention or waitlist control at week 5]
  • Change in Overall Injury-Related Fear [Time frame: Collected at baseline and post-treatment after completion of the intervention or waitlist control at week 5]
Secondary outcome measures (2)
  • Change in Reinjury Anxiety [Time frame: Collected at baseline and post-treatment after completion of the intervention or waitlist control at week 5]
  • Change in Lower Extremity Reaction Time [Time frame: Collected at baseline and post-treatment after completion of the intervention or waitlist control at week 5]

Eligibility criteria

Inclusion criteria

  • Ages 14-35 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
  • 6 months to 10-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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Woollen Gymnasium, 300 South Road — Chapel Hill

Identifiers

NCT: NCT05949177 · 23-1412 · 2223GP01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗