Graded Exposure and Mindfulness Meditation for Patients Post-ACL Reconstruction
The GEMM Trial: Graded Exposure and Mindfulness Meditation for Patients Post- ACL Reconstruction
2 other identifiers
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 26, 2023
CompletedFirst Posted
Study publicly available on registry
July 17, 2023
CompletedStudy Start
First participant enrolled
October 30, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 31, 2026
November 13, 2025
November 1, 2025
1.8 years
June 26, 2023
November 11, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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."
Collected at baseline and post-treatment after completion of the intervention or waitlist control at week 5
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.
Collected at baseline and post-treatment after completion of the intervention or waitlist control at week 5
Secondary Outcomes (2)
Change in Reinjury Anxiety
Collected at baseline and post-treatment after completion of the intervention or waitlist control at week 5
Change in Lower Extremity Reaction Time
Collected at baseline and post-treatment after completion of the intervention or waitlist control at week 5
Study Arms (2)
Graded Exposure and Mindfulness Meditation
EXPERIMENTALThe 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.
Waitlist Control
PLACEBO COMPARATORParticipants 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
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.
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.
Eligibility Criteria
You may qualify if:
- 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
- months to 10-years post-ACLR
You may not qualify if:
- History of secondary ACL injury
- Do not exhibit elevated injury-related fear
- Concomitant surgeries at the time of ACL reconstruction
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Woollen Gymnasium, 300 South Road
Chapel Hill, North Carolina, 27514, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shelby E Baez, Ph.D., ATC
UNC-Chapel Hill
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 26, 2023
First Posted
July 17, 2023
Study Start
October 30, 2024
Primary Completion (Estimated)
July 31, 2026
Study Completion (Estimated)
July 31, 2026
Last Updated
November 13, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Deidentified individual data that supports the results will be shared beginning 9 and continuing for 36 months following publication.
- Access Criteria
- Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC. To further protect the privacy and confidentiality of the data, the data and associated documentation will be made available only under a data-sharing agreement that provides for: (1) requirements to protect patients' privacy and data confidentiality including appropriate data security; (2) restrictions for the transferring of data to others; (3) commitments that the data will be used for research purposes only and not for a profit-making enterprise, and (4) prohibition of manipulation of data for the purposes of attempting to identify research participants.
The proposed research will include data from all patients regardless of successful completion of the proposed experimental protocol; except if a patient withdraws their consent. The final dataset will include demographic information, self-reported knee function and injury-related fear questionnaires, and lower extremity reaction time data. Accompanying the data, a documentation file will be provided containing the methodological procedures used during the collection of the data and providing a key for all variables included within the final dataset. Prior to sharing this data, all personal identifying information will be removed to protect the rights and privacy of the patients.