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

ACL Tear Clinical Trial

— ROAR 2:Pilot  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05338385
• Other study ID #: IRB-P00039872
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 3, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: May 2024
• Source: Boston Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: December 31, 2025
• Est. primary completion date: February 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• ACL Tear
• Anterior Cruciate Ligament Injuries

Intervention

Behavioral:
• Mental Skills Coaching
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.

Locations

Country	Name	City	State
United States	Boston Children's Hospital	Waltham	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston Children's Hospital

Country where clinical trial is conducted

United States, 

References & Publications (15)

Ajilchi B, Amini HR, Ardakani ZP, Zadeh MM, Kisely S. Applying mindfulness training to enhance the mental toughness and emotional intelligence of amateur basketball players. Australas Psychiatry. 2019 Jun;27(3):291-296. doi: 10.1177/1039856219828119. Epub 2019 Feb 14. — View Citation

Hettrich CM, Dunn WR, Reinke EK; MOON Group; Spindler KP. The rate of subsequent surgery and predictors after anterior cruciate ligament reconstruction: two- and 6-year follow-up results from a multicenter cohort. Am J Sports Med. 2013 Jul;41(7):1534-40. doi: 10.1177/0363546513490277. Epub 2013 May 30. — View Citation

Humphrey, J. H., Yow, D. A., & Bowden, W. W. (2000). Stress in college athletics: Causes, consequences, coping. The Haworth Half-Court Press. Binghamton, NY.

Jones BJ, Kaur S, Miller M, Spencer RMC. Mindfulness-Based Stress Reduction Benefits Psychological Well-Being, Sleep Quality, and Athletic Performance in Female Collegiate Rowers. Front Psychol. 2020 Sep 18;11:572980. doi: 10.3389/fpsyg.2020.572980. eCollection 2020. — View Citation

Kimball, A., & Freysinger, V. J. (2003). Leisure, stress, and coping: The sport participation of collegiate student-athletes. Leisure Sciences, 25(2-3), 115-141.

Lohmander LS, Englund PM, Dahl LL, Roos EM. The long-term consequence of anterior cruciate ligament and meniscus injuries: osteoarthritis. Am J Sports Med. 2007 Oct;35(10):1756-69. doi: 10.1177/0363546507307396. Epub 2007 Aug 29. — View Citation

Oiestad BE, Holm I, Aune AK, Gunderson R, Myklebust G, Engebretsen L, Fosdahl MA, Risberg MA. Knee function and prevalence of knee osteoarthritis after anterior cruciate ligament reconstruction: a prospective study with 10 to 15 years of follow-up. Am J Sports Med. 2010 Nov;38(11):2201-10. doi: 10.1177/0363546510373876. Epub 2010 Aug 16. — View Citation

Oiestad BE, Holm I, Engebretsen L, Risberg MA. The association between radiographic knee osteoarthritis and knee symptoms, function and quality of life 10-15 years after anterior cruciate ligament reconstruction. Br J Sports Med. 2011 Jun;45(7):583-8. doi: 10.1136/bjsm.2010.073130. Epub 2010 Jul 20. — View Citation

Papanikolaou, Z., Nikolaidis, D., Patsiaouras, A., & Alexopoulos, P. (2003). The freshman experience: High stress-low grades. Athletic Insight: The On-line Journal of Sport Psychology, 5.

Paterno MV, Schmitt LC, Ford KR, Rauh MJ, Myer GD, Huang B, Hewett TE. Biomechanical measures during landing and postural stability predict second anterior cruciate ligament injury after anterior cruciate ligament reconstruction and return to sport. Am J Sports Med. 2010 Oct;38(10):1968-78. doi: 10.1177/0363546510376053. Epub 2010 Aug 11. — View Citation

Rothlin P, Birrer D, Horvath S, Grosse Holtforth M. Psychological skills training and a mindfulness-based intervention to enhance functional athletic performance: design of a randomized controlled trial using ambulatory assessment. BMC Psychol. 2016 Jul 26;4(1):39. doi: 10.1186/s40359-016-0147-y. — View Citation

Sallen J, Hemming K, Richartz A. Facilitating dual careers by improving resistance to chronic stress: effects of an intervention programme for elite student athletes. Eur J Sport Sci. 2018 Feb;18(1):112-122. doi: 10.1080/17461391.2017.1407363. Epub 2017 Dec 3. — View Citation

Vealey, S. R. (2007). Mental skills training in sport. In G. Tenenbaum, R. Eklund, & R. Singer (Eds.), Handbook of sport psychology (pp. 287-309). Wiley. Hoboken, NJ.

Wojtys EM, Brower AM. Anterior cruciate ligament injuries in the prepubescent and adolescent athlete: clinical and research considerations. J Athl Train. 2010 Sep-Oct;45(5):509-12. doi: 10.4085/1062-6050-45.5.509. No abstract available. — View Citation

Wright RW, Magnussen RA, Dunn WR, Spindler KP. Ipsilateral graft and contralateral ACL rupture at five years or more following ACL reconstruction: a systematic review. J Bone Joint Surg Am. 2011 Jun 15;93(12):1159-65. doi: 10.2106/JBJS.J.00898. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Compliance	Compliance will be calculated as the number of mental skills coaching sessions attended out of the six planned visits.	Preop consult, 2 weeks postop, 6 weeks postop, 3 months postop, 6 months postop, 9 months postop
Other	Proportion of Participation	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.	Preop consult
Primary	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
Primary	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