Mindfulness and ACL Surgery

Study Overview
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Brief Summary
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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
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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

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

Conditions
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ACL, ACL Injury

Intervention / Treatment
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* Behavioral: Healthy Minds Program (HMP) App


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness Intervention plus Standard of Care<br>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<br>* 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.<br>|
| No Intervention: Standard of Care<br>Control group receives standard of care only | |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ACL Surgery, mindfulness