Mindfulness and ACL Surgery

The Influence of Mindfulness on Patient-Reported Outcomes, Return to Sport and Re-Injury Following Anterior Cruciate Ligament (ACL) Reconstruction Surgery

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.

Study Overview

• Status: Active, not recruiting
• Conditions: ACL; ACL Injury
• Intervention / Treatment: Behavioral: Healthy Minds Program (HMP) App

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
• Enrollment (Actual): 47
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53705
      • University of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 16-40 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mindfulness Intervention plus Standard of Care; 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.	Behavioral: Healthy Minds Program (HMP) App; The full HMP app includes 5 modules with practices designed to cultivate categories of mental and emotional skills linked to both hedonic and eudaimonic well-being. These include the cultivation of mindful attention (Awareness), positive relationships with self and others (Connection), insight into the nature of self and internal experience (Insight), and purpose, values, and meaning in life (Purpose), as well as an initial module which includes abbreviated introductions to the topics and lessons in all four areas (Foundations). For this study, the active intervention will include 4 weeks of training using the Foundations module followed by 4 weeks of training using the Awareness module.
No Intervention: Standard of Care; Control group receives standard of care only

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in PROMIS Global Health Questionnaire (GHQ) Score	Global quality of life (QoL) will be assessed via a 9-item questionnaire scored on a 0-100 scale where higher scores indicate better QoL, pain interference, and fatigue.	baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery
Change in PROMIS Anxiety Questionnaire Score	Anxiety will be assessed via an 8-item questionnaire scored from 0-5 where higher scores represents greater anxiety.	baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery
Change in PROMIS Depression Questionnaire Score	Depression will be assessed via an 8-item questionnaire scored from 0-5 where higher scores represents greater depression.	baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery
Change in Single Assessment Numeric Evaluation (SANE) Score	Pain severity is assessed via a single item survey scored from 0-100 where a higher score indicates greater pain.	baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery
Change in Horowitz Impact of Events Scale Score	Post-traumatic stress is assessed via a 15-item survey scored from 0-3 where higher scores indicate greater level of post-traumatic stress.	baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery
Change in Tampa Scale of Kinesiophobia 11 (TSK-11) Score	Fear of re-injury is assessed via an 11-item survey scored from 1-4 where higher scores indicate a greater fear of re-injury.	baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery
Change in Pain Catastrophizing Scale (PCS) Score	Pain catastrophizing is assessed via a 13-item survey scored from 0-4 where higher scores indicate a higher level of pain catastrophizing.	baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery
Change in Anterior Cruciate Ligament Return to Sport After Injury scale (ACL-RSI) Score	Psychological readiness is assessed via a 12-item survey scored on an 11-point scale where higher scores indicate a higher level of readiness.	baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery
Change in Athletic Identity Measurement Scale (AIMS) Score	Athletic identity is assessed via a 10-item survey with a total range of scores from 10-70 where higher scores indicate a higher level of athletic identity.	baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery
Change in International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form Score	Knee function is assessed via a 10-item survey scored from 0-10 where higher scores means less limitation with activities and less symptoms.	baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery
Change in General physical activity questionnaire (GPAQ) Measured as Minutes of Total Physical Activity per day	Higher score indicates higher physical activity.	baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knee Range of Motion		6 weeks, 3 months, 6 months, 12 months, 24 months post surgery
Peak Torque	Participants will undergo testing of resisted flexion and extension to determine peak torque	6 weeks, 3 months, 6 months, 12 months, 24 months post surgery
Peak Torque Relative to Body Weight	Participants will undergo testing of resisted flexion and extension to determine peak torque relative to body weight	6 weeks, 3 months, 6 months, 12 months, 24 months post surgery
Hamstring to Quadriceps Torque Ratio	Participants will undergo testing of resisted flexion and extension to determine hamstring to quadriceps torque ratio.	6 weeks, 3 months, 6 months, 12 months, 24 months post surgery
Change in Jump Landing Assessment: Force Measures	loading force, acceleration force, landing force, peak landing force on both legs together	6 weeks, 3 months, 6 months, 12 months, 24 months post surgery
Change in Jump Height		6 weeks, 3 months, 6 months, 12 months, 24 months post surgery
Change in Vertical Hop Testing: Force Measures	down force, up force, landing force, peak landing force on a single leg	6 weeks, 3 months, 6 months, 12 months, 24 months post surgery
Change in Hop Height		6 weeks, 3 months, 6 months, 12 months, 24 months post surgery
Total Duration of Mindfulness Intervention in the Mindfulness Group		up to 24 months
Number of Participants Who Return to Sport		up to 24 months

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Investigators: Principal Investigator: Andrew Watson, MD, MS, University of Wisconsin, Madison

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: September 12, 2022
• First Submitted That Met QC Criteria: September 12, 2022
• First Posted (Actual): September 15, 2022

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 23, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: ACL Surgery; mindfulness
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Knee Injuries; Anterior Cruciate Ligament Injuries; Amino Acids, Peptides, and Proteins; Proteins; Macromolecular Substances; Multiprotein Complexes; Amyloid
• Other Study ID Numbers: 2021-0845; A536110 (Other Identifier: UW Madison); Protocol Version 10/10/2023 (Other Identifier: UW Madison)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No