Brief Title
Mindfulness and ACL Surgery
Official Title
The Influence of Mindfulness on Patient-Reported Outcomes, Return to Sport and Re-Injury Following Anterior Cruciate Ligament (ACL) Reconstruction Surgery
Brief Summary
Anterior cruciate ligament (ACL) surgery patients experience physical trauma, both in the physical injury itself and following surgery, and face potential long-lasting adverse effects such as muscle weakness, diminished joint function, hip pain, and fear. Many of these patients report more significant anxiety and depression following surgery, which can further compound these patients' adverse outcomes. This study is a single-blind, randomized controlled trial design to evaluate the effects of a remotely-delivered 8-week mindfulness intervention on patient-reported outcomes (PROs) following ACL reconstruction surgery.
Detailed Description
Rationale and Approach: ACL reconstruction surgery patients experience physical trauma, both in the physical injury itself and following surgery, and face potential adverse long-lasting effects such as muscle weakness, arthritis, persistent knee pain, anxiety, depression, post-traumatic stress, and fear of re-injury. Many of these patients report sufficient psychological trauma that undermines a return to sport and potentially contributes to the risk of re-injury to the repaired knee. This study is a single-blind, randomized controlled trial design to evaluate the effects of a remotely-delivered 8-week mindfulness intervention on patient-reported outcomes following ACL reconstruction surgery. - Specific Aim 1: To determine the influence of mindfulness training on patient-reported outcomes and return to sport following ACL reconstruction surgery - Hypothesis 1: Mindfulness training will be associated with improvements in pain, quality of life, depression, anxiety, post-traumatic stress and fear of re-injury, as well as greater likelihood of returning to sport in the 24 months following ACL reconstruction surgery - Specific Aim 2: To determine the influence of mindfulness training on re-injury risk following ACL reconstruction surgery - Hypothesis 2: Among those participants that return to sport, mindfulness training will be associated with a decreased risk of ipsilateral ACL rupture in the 24 months following ACL reconstruction surgery - Specific Aim 3: To determine the factors that influence mindfulness efficacy in patient-reported outcomes and return to sport following ACL reconstruction surgery - Hypothesis 3: Among participants in the mindfulness group, total duration of mindfulness training and female gender will be independently associated with improvements in pain, quality of life, depression, anxiety, post-traumatic stress and fear of re-injury, as well as greater likelihood of returning to sport in the 24 months following ACL reconstruction surgery
Study Type
Interventional
Primary Outcome
Change in PROMIS Global Health Questionnaire (GHQ) Score
Secondary Outcome
Knee Range of Motion
Condition
ACL
Intervention
Healthy Minds Program (HMP) App
Study Arms / Comparison Groups
Mindfulness Intervention plus Standard of Care
Description: The Foundations and Awareness modules of the HMP app require a minimum of 133 and 253 minutes, equating to less than 5 and less than 10 minutes per day on average, respectively. Date, duration, and content of usage will be recorded for each participant through the app. Participants will have access to the entire contents of the app for the full duration of the study.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Behavioral
Estimated Enrollment
200
Start Date
July 1, 2022
Completion Date
April 2025
Primary Completion Date
April 2025
Eligibility Criteria
Inclusion Criteria: - 18-40 years old at the time of the pre-operative visit - Regular access to a mobile device compatible with the Healthy Minds Program (HMP) App (Android or iOS) - Undergoing ACL surgery Exclusion Criteria: - Prior diagnosis of serious mental illness (schizophrenia, bipolar disorder, schizoaffective disorder, etc). - Significant prior experience with meditation or mindfulness, defined as greater than 30 minutes in a month during the past year - Knee injury requiring multi-ligament reconstruction - Prior ipsilateral knee surgery - Prior contralateral ACL reconstruction
Gender
All
Ages
18 Years - 40 Years
Accepts Healthy Volunteers
No
Contacts
Andrew Watson, MD, MS, 608-263-6647, [email protected]
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT05542563
Organization ID
2021-0845
Secondary IDs
Protocol Version 2/15/2022
Responsible Party
Sponsor
Study Sponsor
University of Wisconsin, Madison
Study Sponsor
Andrew Watson, MD, MS, Principal Investigator, University of Wisconsin, Madison
Verification Date
January 2023