Graded Exposure and Mindfulness Meditation for Patients Post-ACL Reconstruction

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age14-35
SponsorUniversity of North Carolina, Chapel Hill

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

History of secondary ACL injury

Do not exhibit elevated injury-related fear

Concomitant surgeries at the time of ACL reconstruction

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Graded Exposure and Mindfulness MeditationExperimental treatment 1 intervention
Group B: Waitlist ControlPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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."

Time frame
Collected at baseline and post-treatment after completion of the intervention or waitlist control at week 5
2

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.

Time frame
Collected at baseline and post-treatment after completion of the intervention or waitlist control at week 5

Secondary outcomes

1

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

Time frame
Collected at baseline and post-treatment after completion of the intervention or waitlist control at week 5
2

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).

Time frame
Collected at baseline and post-treatment after completion of the intervention or waitlist control at week 5

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of North Carolina, Chapel Hill

Lead sponsor

National Athletic Trainers' Association Research & Education Foundation (NATA Foundation)

Collaborator