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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
200
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.
University of Wisconsin
Madison, Wisconsin, United States
RECRUITINGChange 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery
Knee Range of Motion
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery
Change in Jump Height
Time frame: 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
Time frame: 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery
Change in Hop Height
Time frame: 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery
Total Duration of Mindfulness Intervention in the Mindfulness Group
Time frame: up to 24 months
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Number of Participants Who Return to Sport
Time frame: up to 24 months