Study Summary
This trial will explore if a mental skills training program can help athletes who tear their ACL and need surgery to feel confident about returning to their sport.
Eligible Conditions
- Anterior Cruciate Ligament Tears
Treatment Effectiveness
Phase-Based Effectiveness
N/A
Study Objectives
2 Primary · 0 Secondary · Reporting Duration: Preop consult, 2 weeks postop, 6 weeks postop, 3 months postop, 6 months postop, 9 months postop
6-9 months postop
ACL-Return to Sports after Injury (ACL-RSI)
PROMIS Psychological Stress Experience - Bank (CAT version)
Preop consult
Proportion of Participation
Month 9
Compliance
Trial Safety
Phase-Based Safety
Awards & Highlights
No Placebo Group
All patients enrolled in this trial will receive the new treatment.
Trial Design
1 Treatment Group
Intervention
1 of 1
Experimental Treatment
30 Total Participants · 1 Treatment Group
Primary Treatment: Mental Skills Coaching · No Placebo Group · N/A
Intervention
Behavioral
Experimental Group · 1 Intervention: Mental Skills Coaching · Intervention Types: BehavioralTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: preop consult, 2 weeks postop, 6 weeks postop, 3 months postop, 6 months postop, 9 months postop
Who is running the clinical trial?
Boston Children's HospitalLead Sponsor
726 Previous Clinical Trials
5,432,024 Total Patients Enrolled
Matthew D Milewski, MDPrincipal InvestigatorBoston Children's Hospital
1 Previous Clinical Trials
120 Total Patients Enrolled
Eligibility Criteria
Age 8 - 25 · All Participants · 0 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:References
- Lohmander, L. Stefan, P. Martin Englund, Ludvig L. Dahl, and Ewa M. Roos. 2007. “The Long-term Consequence of Anterior Cruciate Ligament and Meniscus Injuries”. The American Journal of Sports Medicine. SAGE Publications. doi:10.1177/0363546507307396.
- Øiestad, Britt Elin, Inger Holm, Arne Kristian Aune, Ragnhild Gunderson, Grethe Myklebust, Lars Engebretsen, Merete Aarsland Fosdahl, and May Arna Risberg. 2010. “Knee Function and Prevalence of Knee Osteoarthritis After Anterior Cruciate Ligament Reconstruction”. The American Journal of Sports Medicine. SAGE Publications. doi:10.1177/0363546510373876.
- Humphrey, J. H., Yow, D. A., & Bowden, W. W. (2000). Stress in college athletics: Causes, consequences, coping. The Haworth Half-Court Press. Binghamton, NY.
- Sallen, Jeffrey, Karen Hemming, and Alfred Richartz. 2017. “Facilitating Dual Careers by Improving Resistance to Chronic Stress: Effects of an Intervention Programme for Elite Student Athletes”. European Journal of Sport Science. Informa UK Limited. doi:10.1080/17461391.2017.1407363.
- Jones, Bethany J., Sukhmanjit Kaur, Michele Miller, and Rebecca M. C. Spencer. 2020. “Mindfulness-based Stress Reduction Benefits Psychological Well-being, Sleep Quality, and Athletic Performance in Female Collegiate Rowers”. Frontiers in Psychology. Frontiers Media SA. doi:10.3389/fpsyg.2020.572980.
- Paterno, Mark V., Laura C. Schmitt, Kevin R. Ford, Mitchell J. Rauh, Gregory D. Myer, Bin Huang, and Timothy E. Hewett. 2010. “Biomechanical Measures During Landing and Postural Stability Predict Second Anterior Cruciate Ligament Injury After Anterior Cruciate Ligament Reconstruction and Return to Sport”. The American Journal of Sports Medicine. SAGE Publications. doi:10.1177/0363546510376053.
- Röthlin, Philipp, Daniel Birrer, Stephan Horvath, and Martin grosse Holtforth. 2016. “Psychological Skills Training and a Mindfulness-based Intervention to Enhance Functional Athletic Performance: Design of a Randomized Controlled Trial Using Ambulatory Assessment”. BMC Psychology. Springer Science and Business Media LLC. doi:10.1186/s40359-016-0147-y.
- 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.
- Kimball, A., & Freysinger, V. J. (2003). Leisure, stress, and coping: The sport participation of collegiate student-athletes. Leisure Sciences, 25(2-3), 115-141.
- Wojtys, Edward M., and Ashley M. Brower. 2010. “Anterior Cruciate Ligament Injuries in the Prepubescent and Adolescent Athlete: Clinical and Research Considerations”. Journal of Athletic Training. Journal of Athletic Training/NATA. doi:10.4085/1062-6050-45.5.509.
- Hettrich, Carolyn M., Warren R. Dunn, Emily K. Reinke, Kurt P. Spindler, Richard D. Parker, Jack T. Andrish, Christopher C. Kaeding, et al.. 2013. “The Rate of Subsequent Surgery and Predictors After Anterior Cruciate Ligament Reconstruction”. The American Journal of Sports Medicine. SAGE Publications. doi:10.1177/0363546513490277.
- Oiestad, B. E., I. Holm, L. Engebretsen, and M. A. Risberg. 2010. “The Association Between Radiographic Knee Osteoarthritis and Knee Symptoms, Function and Quality of Life 10-15 Years After Anterior Cruciate Ligament Reconstruction”. British Journal of Sports Medicine. BMJ. doi:10.1136/bjsm.2010.073130.
- Wright, Rick W., Robert A. Magnussen, Warren R. Dunn, and Kurt P. Spindler. 2011. “Ipsilateral Graft and Contralateral ACL Rupture at Five Years or More Following ACL Reconstruction”. The Journal of Bone & Joint Surgery. Ovid Technologies (Wolters Kluwer Health). doi:10.2106/jbjs.j.00898.
- 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.
- Ajilchi, Bita, Hamid Reza Amini, Zahra Pouraghaei Ardakani, Majid Mozafari Zadeh, and Steve Kisely. 2019. “Applying Mindfulness Training to Enhance the Mental Toughness and Emotional Intelligence of Amateur Basketball Players”. Australasian Psychiatry. SAGE Publications. doi:10.1177/1039856219828119.
- 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.
- 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.
- 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.
- 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.
- 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.
- Matthew Milewski 2022. "Readiness Outcomes Affecting Return to Sport 2.0: An Intervention Feasibility & Pilot Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05338385.
Frequently Asked Questions
Has this clinical experiment opened enrollment yet?
"According to clinicaltrials.gov, this study is still open for enrollment and had its initial post date on May 3rd 2022 with a most recent edit occurring June 27th of the same year." - Anonymous Online Contributor
Unverified Answer
Does the protocol for this experiment restrict enrollment to adults only?
"The conditions for trial participation necessitate that potential participants be between the ages of 8 to 25 years old. There are 47 studies available for individuals below 18 and 26 trials catered towards seniors above 65 years of age." - Anonymous Online Contributor
Unverified Answer
Who is eligible for participation in this experiment?
"This clinical trial seeks 30 participants aged 8 to 25 who have suffered a complete tear in the anterior cruciate ligament (ACL). Furthermore, these patients must meet certain stipulations: they must be English speakers and their surgery should occur at Boston Children's Hospital with one of the participating surgeons." - Anonymous Online Contributor
Unverified Answer
How many participants are engaging with this research?
"Affirmative. According to clinicaltrials.gov, this medical exploration began on May 3rd 2022 and was recently amended on June 27th 2022; it is currently recruiting 30 patients from a single site." - Anonymous Online Contributor
Unverified Answer