Readiness Outcomes Affecting Return to Sport 2.0: An Intervention Feasibility & Pilot Study

Study Overview
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Brief Summary
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This study aims to determine the feasibility of implementing a mental skills training intervention for adolescent athletes who tear their ACL and undergo ACL reconstruction surgery alongside receiving standard-of-care clinical treatment. The study will also determine if the mental skills coaching program has any effect on the psychological readiness of patients to return to sport after undergoing surgery and postoperative recovery and rehabilitation. If feasible and if the mental skills training program shows promising effect on athletes' confidence in returning to sport, a large-scale clinical trial can be explored to assess the relationship between mental skills' impact on readiness to return to sport, which could in turn provide evidence on the benefits of integrating mental skills directly into standard clinical care.

Detailed Description
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Approximately 350,000 individuals undergo anterior cruciate ligament (ACL) surgery with using allograft or autograft in the US annually. Even with successful ACL surgery, subsequent ACL tear occurs at a rate of 2-24% in physically active population. Most published reports focused on the young adult population, but few studies have focused on physically active young athletes and their return to sports (RTS) after surgery. As successful RTS following ACL reconstruction can be physically and psychologically challenging, increased attention has been directed to better understand the role a patient's psychological readiness to RTS plays in the rehabilitation phase, but there is an overall need to establish effective tools to help improve psychological readiness to RTS during this phase. Mental skills training aims to improve athlete performance. Individuals involved in collegiate-level sports face the challenge of balancing rigorous athletic and academic demands. Given these demands, there is increasing need for programs to help athletes at varying levels and ages develop the skills necessary to maintain optimal performance. Such programs speak to the need for student-athletes to train their mental game much in the same way they train their physical game. They emphasize the value of and the ability to teach confidence, adaptability, and resilience. Researchers have employed both mindfulness- and psychological skills-based techniques as means to promote student-athlete mental toughness and improved performance outcome. Mindfulness increases nonjudgmental awareness of the present, and is an effective treatment in non-sport related arenas. Psychological skills training educates athletes on how to improve strategies such as imagery, self-talk, goal setting, and arousal regulation. While these interventions may vary somewhat in terms of approach, there is evidence that both tactics positively impact athlete performance. We believe that these theories can be translated to athletes who are recovering from injuries and be used effectively to get patients back to their sports confidently. The goal of mental skills training is to help athletes maximize performance, reach self-determined goals, and build confidence in their fields of play. Many of the same tools that benefit athletes in sport performance also translate to their injury experience. Mental conditioning helps athletes navigate the many ups and downs that accompany ACL injury and recovery. Athletes are taught techniques to maintain their sport mindset by capitalizing on motivation, consistency, and resilience. One-on-one sessions are athlete-centered, and are designed to encourage exploration and growth through tangible mental skills strategies. Topics that may be addressed include mindset awareness, goal setting, stress management, mental imagery, cognitive restructuring, and positive self-talk.

Official Title
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Readiness Outcomes Affecting Return to Sport 2.0: An Intervention Feasibility & Pilot Study

Conditions
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ACL Tear

Intervention / Treatment
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* Behavioral: Mental Skills Coaching


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of a complete anterior cruciate ligament (ACL) tear Undergoing ACL reconstruction at Boston Children's Hospital by a study-participating surgeon Age at time of surgery between 8 and ≤ 25 English-speaking Exclusion Criteria: Torn medial collateral ligament (MCL), lateral collateral ligament (LCL), or posterior cruciate ligament (PCL) requiring reconstruction

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Participants will receive mental skills training in addition to receiving standard-of-care ACL reconstruction and follow-up care. The goal of mental skills training is to help athletes maximize performance, reach self-determined goals, and build confidence in their fields of play. Many of the same tools that benefit athletes in sport performance also translate to their injury experience. Mental conditioning helps athletes navigate the many ups and downs that accompany ACL injury and recovery. Athletes are taught techniques to maintain their sport mindset by capitalizing on motivation, consistency, and resilience. One-on-one sessions are athlete-centered, and are designed to encourage exploration and growth through tangible mental skills strategies. | Behavioral: Mental Skills Coaching<br>* Participants will partake in a 1-hour pre-op initial intake, followed by five 30-min follow-up sessions at 2 weeks, 6 weeks, 3 months, 6 months and 9-months post-op. All sessions will be one-on-one with the same master's-level mental skills coach. At each session, the provider will allow time for participants to share their current injury experience to date (i.e. how they are doing, challenges they have encountered). Following this, participants will be introduced to a series of mental skills tools, including but not limited to mindset awareness, motivation, cognitive restructuring, goal setting, and objective performance assessment. Participants will be provided with handouts outlining the strategies addressed to help maintain consistency of mental skills engagement between sessions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ACL-Return to Sports after Injury (ACL-RSI) | Questionnaire used to measure the psychological impact of returning to sport after ACL reconstruction surgery. Patients will complete this questionnaire at the clinic visit when they are cleared to RTS at either their 6-month or 9-month postoperative follow-up clinical visit. There are 12 questions that are rated on a 0-10 scale. Overall, this outcome measure is scored 0-100 (higher score = more psychologically ready to RTS). A score greater than or equal to 77% indicates that the patient is psychologically ready to RTS. | 6-9 months postop | 
| PROMIS Psychological Stress Experience - Bank (CAT version) | Assesses the thoughts or feelings about the world in the context of environmental or internal challenges. Patients will complete at the time of enrollment, any additional clinical visit, including 3 months, 6 months, and/or 9 months after surgery. There are 19 questions that are rated on a 1-5 scale. Overall, this outcome measure is scored 18-95 (lower score = less stress). Raw scores are then converted into T-scores. | 6-9 months postop | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ACL tear, Mental Skills, Psychological Readiness