Mindfulness and ACL Surgery

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 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

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