Mindfulness and ACL Surgery Study
This study is looking at how a mindfulness app called "Healthy Minds Program (HMP) App" might help people recovering from ACL (anterior cruciate ligament) surgery. If you're between 16 and 40 years old, have regular access to a smartphone or tablet, and are having ACL surgery, you might be able to join. The researchers want to see if using the app can improve your overall health, and reduce feelings of anxiety and depression after surgery. They will measure these things at different times over two years. The study is currently recruiting about 47 participants, but its exact status is unclear.
- Study design
- This is a single-blind, randomized controlled trial, meaning some participants will receive the intervention and others won't, and you won't know which group you're in. About 47 people are expected to join this study.
- What's involved
- You would use the Healthy Minds Program (HMP) App for 8 weeks. Your health, anxiety, and depression will be measured at baseline (before surgery), and then at 6 weeks, 3 months, 6 months, 12 months, and 24 months after surgery.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 24 months after their ACL surgery to track their progress and outcomes.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Mindfulness and ACL Surgery
At a glance
Conditions
NCT05542563
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
University of Wisconsin
Madison, Wisconsinno site contact published
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Andrew Watson, MD, MS · PRINCIPAL_INVESTIGATOR · University of Wisconsin, Madison
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Want this trial checked against your situation?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Inclusion
Exclusion
What this trial measures
- Change in PROMIS Global Health Questionnaire (GHQ) Scorebaseline, 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.
- Change in PROMIS Anxiety Questionnaire Scorebaseline, 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.
- Change in PROMIS Depression Questionnaire Scorebaseline, 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.
- Change in Single Assessment Numeric Evaluation (SANE) Scorebaseline, 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.
- Change in Horowitz Impact of Events Scale Scorebaseline, 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.
- Change in Tampa Scale of Kinesiophobia 11 (TSK-11) Scorebaseline, 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.
- Change in Pain Catastrophizing Scale (PCS) Scorebaseline, 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.
- Change in Anterior Cruciate Ligament Return to Sport After Injury scale (ACL-RSI) Scorebaseline, 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.
- Change in Athletic Identity Measurement Scale (AIMS) Scorebaseline, 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.
- Change in International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form Scorebaseline, 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.
- Change in General physical activity questionnaire (GPAQ) Measured as Minutes of Total Physical Activity per daybaseline, 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery
Higher score indicates higher physical activity.