Recruiting

Graded Exposure & Mindfulness

Sponsor:

University of North Carolina, Chapel Hill

Code:

NCT05949177

Conditions

Anterior Cruciate Ligament Injuries

Eligibility Criteria

Sex: All

Age: 14 - 35

Healthy Volunteers: Not accepted

Interventions

Graded Exposure and Mindfulness Meditation

Waitlist Control

Study Details

Brief 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.

Conditions

Anterior Cruciate Ligament Injuries

Study ID

NCT05949177

Start date

Oct 30, 2024

Status verified date

Nov, 2025

Completion date

Jul 31, 2026

Anticipated

Primary completion date

Jul 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 14 - 35

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

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.

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 ]
  • 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 ]

Central Contacts and Locations

Central contacts

Shelby E Baez, Ph.D., ATC

919-445-1500sbaez@unc.edu

Locations

Woollen Gymnasium, 300 South Road

Recruiting

Chapel Hill, North Carolina, United States, 27514

Contacts

Shelby E Baez, Ph.D.., ATC

919-445-1500sbaez@unc.edu

More Information

Sponsor

University of North Carolina, Chapel Hill

Last update posted

Nov 13, 2025

Last verified

Nov, 2025

Keywords

  • Rehabilitation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of North Carolina, Chapel Hill on 2025-11-13.