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OpenTrials
Active, Not Recruiting

NCT Number: NCT05338385

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

8 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Boston Children's Hospital

Waltham, Massachusetts, 02453, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mental Skills Coaching

Behavioral

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.

Primary outcomes

  1. ACL-Return to Sports after Injury (ACL-RSI)

    Time frame: 6-9 months postop

    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.

  2. PROMIS Psychological Stress Experience - Bank (CAT version)

    Time frame: 6-9 months postop

    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.

Other outcomes

  1. Compliance

    Time frame: Preop consult, 2 weeks postop, 6 weeks postop, 3 months postop, 6 months postop, 9 months postop

    Compliance will be calculated as the number of mental skills coaching sessions attended out of the six planned visits.

  2. Proportion of Participation

    Time frame: Preop consult

    This will be defined as the number of people who agreed to participate in a mental skills course divided by the number of people who were approached.

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Registry information

Acronym: ROAR 2:Pilot

Important dates

Study start
2022
Primary completion
2023
Study completion
2026
First posted
Apr 21, 2022
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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