[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05949177":3,"trial-entities:NCT05949177":97,"trial-summary:NCT05949177":101},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":39,"secondary_outcomes":47,"sex":54,"minimum_age":55,"maximum_age":56,"healthy_volunteers":15,"eligibility_criteria":57,"std_ages":69,"locations":72,"central_contacts":88,"overall_officials":91,"references":95,"see_also_links":96},"NCT05949177","23-1412","Graded Exposure and Mindfulness Meditation for Patients Post-ACL Reconstruction","The GEMM Trial: Graded Exposure and Mindfulness Meditation for Patients Post- ACL Reconstruction","RECRUITING","2026-07-31","2025-11","2025-11-13","2024-10-30","University of North Carolina, Chapel Hill","OTHER",false,"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.","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.",[19],"Anterior Cruciate Ligament Injuries",[21],"Rehabilitation","INTERVENTIONAL","TREATMENT",[25],"NA",{"count":27,"type":28},50,"ESTIMATED",[30,35],{"type":31,"name":32,"description":33,"armGroupLabels":34},"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.",[32],{"type":31,"name":36,"description":37,"armGroupLabels":38},"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.",[36],[40,44],{"measure":41,"description":42,"timeFrame":43},"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",{"measure":45,"description":46,"timeFrame":43},"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.\n\nAIM 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.",[48,51],{"measure":49,"description":50,"timeFrame":43},"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",{"measure":52,"description":53,"timeFrame":43},"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).","ALL","14 Years","35 Years",{"inclusion":58,"exclusion":64,"raw_text":68},[59,60,61,62,63],"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",[65,66,67],"History of secondary ACL injury","Do not exhibit elevated injury-related fear","Concomitant surgeries at the time of ACL reconstruction","Inclusion Criteria:\n\n* Ages 14-35 years\n* Have self-reported levels of fear on the Tampa Scale of Kinesiophobia-11 and the Photographic Series of Sports Activities for ACLR\n* Injured their knee playing or training for sports (recreational or organized)\n* Have a history of unilateral ACLR\n* 6 months to 10-years post-ACLR\n\nExclusion Criteria:\n\n* History of secondary ACL injury\n* Do not exhibit elevated injury-related fear\n* Concomitant surgeries at the time of ACL reconstruction",[70,71],"CHILD","ADULT",[73],{"facility":74,"status":8,"city":75,"state":76,"zip":77,"country":78,"contacts":79,"geoPoint":85},"Woollen Gymnasium, 300 South Road","Chapel Hill","North Carolina","27514","United States",[80],{"name":81,"role":82,"phone":83,"email":84},"Shelby E Baez, Ph.D.., ATC","CONTACT","919-445-1500","sbaez@unc.edu",{"lat":86,"lon":87},35.9132,-79.05584,[89],{"name":90,"role":82,"phone":83,"email":84},"Shelby E Baez, Ph.D., ATC",[92],{"name":90,"affiliation":93,"role":94},"UNC-Chapel Hill","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":98,"biomarkers":100},[99],"Injury of anterior cruciate ligament",[],{"nct_id":4,"found":102,"summary":103,"prompt_version":113},true,{"design":104,"status":105,"heading":106,"summary":107,"follow_up":108,"word_count":109,"commitments":110,"compensation":111,"drugs_mentioned":112},"This is an interventional study planning to enroll 50 participants. You would be randomly assigned to either the Graded Exposure and Mindfulness Meditation group or a waitlist control group.","completed","Graded Exposure and Mindfulness Meditation for ACL Reconstruction Recovery","This study is looking at whether a combination of Graded Exposure (gradually facing fear-inducing situations) and Mindfulness Meditation (guided through the Headspace app) can help people who have had ACL (anterior cruciate ligament) reconstruction surgery. The goal is to reduce fear related to their injury and improve their reaction time. You might be able to join if you are 14-35 years old, had ACL surgery 6 months to 10 years ago, and still experience fear related to your knee injury. The study aims to see if this approach can decrease your fear and anxiety and make your reaction time faster compared to a group that waits to receive the Headspace app. The current recruitment status is unclear.","Your fear levels and reaction time will be measured at the beginning and after 5 weeks, at the end of the intervention or waitlist period.",117,"If you are in the Graded Exposure and Mindfulness Meditation group, you will complete graded exposure once a week and use the Headspace app for mindfulness meditation for 5 weeks. If you are in the waitlist control group, you will be asked not to change your normal routines or download relaxation apps for 5 weeks.","Not stated in the trial record.",[],"v2"]