Mindfulness and ACL Surgery

NCT05542563 | Active Not Recruiting

• 3 other identifiers: 2021-0845Protocol Version 10/10/2023A536110
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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.

Conditions

ACL; ACL Injury

Keywords

ACL Surgery; mindfulness

Outcome Measures

Primary Outcomes (11)

• 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 Outcomes (10)

• Knee Range of Motion

  6 weeks, 3 months, 6 months, 12 months, 24 months post surgery

• Peak Torque

  6 weeks, 3 months, 6 months, 12 months, 24 months post surgery

• Peak Torque Relative to Body Weight

  6 weeks, 3 months, 6 months, 12 months, 24 months post surgery

• Hamstring to Quadriceps Torque Ratio

  6 weeks, 3 months, 6 months, 12 months, 24 months post surgery

• Change in Jump Landing Assessment: Force Measures

  6 weeks, 3 months, 6 months, 12 months, 24 months post surgery

Study Arms (2)

Mindfulness Intervention plus Standard of Care

EXPERIMENTAL

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

Standard of Care

NO INTERVENTION

Control group receives standard of care only

Interventions

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.

Mindfulness Intervention plus Standard of Care

Eligibility Criteria

• Age: 16 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53705, United States

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Interventions

Amyloid

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Multiprotein Complexes; Macromolecular Substances; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Andrew Watson, MD, MS

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: All healthcare providers involved in the care of the participant following surgery (surgeon, physician's assistants, nurses, medical assistants, etc.) will be blinded to the group assignment of each participant.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: September 12, 2022
• First Posted: September 15, 2022
• Study Start: July 1, 2022
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)