Clinical trial NCT05338385: Readiness Outcomes Affecting Return to Sport 2.0: An Intervention Feasibility & Pilot Study
Official title: Readiness Outcomes Affecting Return to Sport 2.0: An Intervention Feasibility & Pilot Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: ACL Tear
Keywords: ACL tear
Mental Skills
Psychological Readiness
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2022-04-21
Enrollment: 30
Sex: ALL
Minimum age (years): 8
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: ACL-Return to Sports after Injury (ACL-RSI)
timeFrame: 6-9 months postop
measure: PROMIS Psychological Stress Experience - Bank (CAT version)
timeFrame: 6-9 months postop
Secondary outcomes:
Other outcomes:
measure: Compliance
timeFrame: Preop consult, 2 weeks postop, 6 weeks postop, 3 months postop, 6 months postop, 9 months postop
measure: Proportion of Participation
timeFrame: Preop consult
Locations:
city: Waltham
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Matthew D Milewski, MD
role: PRINCIPAL_INVESTIGATOR
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