Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT05542563

Mindfulness and ACL 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

ACL ACL Injury Anterior Cruciate Ligament Injuries Knee Injuries Leg Injuries Wounds and Injuries

Age range

16 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Wisconsin

Madison, Wisconsin, 53705, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Healthy Minds Program (HMP) App

Behavioral

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.

Primary outcomes

  1. Change in PROMIS Global Health Questionnaire (GHQ) Score

    Time frame: baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery

    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.

  2. Change in PROMIS Anxiety Questionnaire Score

    Time frame: baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery

    Anxiety will be assessed via an 8-item questionnaire scored from 0-5 where higher scores represents greater anxiety.

  3. Change in PROMIS Depression Questionnaire Score

    Time frame: baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery

    Depression will be assessed via an 8-item questionnaire scored from 0-5 where higher scores represents greater depression.

  4. Change in Single Assessment Numeric Evaluation (SANE) Score

    Time frame: baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery

    Pain severity is assessed via a single item survey scored from 0-100 where a higher score indicates greater pain.

  5. Change in Horowitz Impact of Events Scale Score

    Time frame: baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery

    Post-traumatic stress is assessed via a 15-item survey scored from 0-3 where higher scores indicate greater level of post-traumatic stress.

  6. Change in Tampa Scale of Kinesiophobia 11 (TSK-11) Score

    Time frame: baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery

    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.

  7. Change in Pain Catastrophizing Scale (PCS) Score

    Time frame: baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery

    Pain catastrophizing is assessed via a 13-item survey scored from 0-4 where higher scores indicate a higher level of pain catastrophizing.

  8. Change in Anterior Cruciate Ligament Return to Sport After Injury scale (ACL-RSI) Score

    Time frame: baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery

    Psychological readiness is assessed via a 12-item survey scored on an 11-point scale where higher scores indicate a higher level of readiness.

  9. Change in Athletic Identity Measurement Scale (AIMS) Score

    Time frame: baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery

    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.

  10. Change in International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form Score

    Time frame: baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery

    Knee function is assessed via a 10-item survey scored from 0-10 where higher scores means less limitation with activities and less symptoms.

  11. Change in General physical activity questionnaire (GPAQ) Measured as Minutes of Total Physical Activity per day

    Time frame: baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery

    Higher score indicates higher physical activity.

Secondary outcomes

  1. Knee Range of Motion

    Time frame: 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery

  2. Peak Torque

    Time frame: 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery

    Participants will undergo testing of resisted flexion and extension to determine peak torque

  3. Peak Torque Relative to Body Weight

    Time frame: 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery

    Participants will undergo testing of resisted flexion and extension to determine peak torque relative to body weight

  4. Hamstring to Quadriceps Torque Ratio

    Time frame: 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery

    Participants will undergo testing of resisted flexion and extension to determine hamstring to quadriceps torque ratio.

  5. Change in Jump Landing Assessment: Force Measures

    Time frame: 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery

    loading force, acceleration force, landing force, peak landing force on both legs together

  6. Change in Jump Height

    Time frame: 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery

  7. Change in Vertical Hop Testing: Force Measures

    Time frame: 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery

    down force, up force, landing force, peak landing force on a single leg

  8. Change in Hop Height

    Time frame: 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery

  9. Total Duration of Mindfulness Intervention in the Mindfulness Group

    Time frame: up to 24 months

  10. Number of Participants Who Return to Sport

    Time frame: up to 24 months

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Sep 15, 2022
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.