ACL Recovery with Virtual Psychological Intervention
This study is looking at whether a virtual psychological intervention (VPI) can help people recover better after Anterior Cruciate Ligament Reconstruction (ACLR) surgery. VPI uses Cognitive Behavioral Therapy (CBT) modules delivered online before and after surgery. You might be able to join if you are over 12 years old, having your first ACLR surgery on one knee with a Henry Ford Sports Orthopedic Surgeon, and do not have certain other knee injuries or infections. The study will measure how many people return to sports, their physical function, pain, and mental health (depression) at 3, 6, 12, and 24 months after surgery. The study is currently unclear on its recruitment status and plans to enroll 60 participants.
- Study design
- This is a randomized controlled trial, meaning participants will be randomly assigned to one of two groups. One group will receive the virtual psychological intervention in addition to standard care, and the other will receive only standard care.
- What's involved
- Participants will receive either standard post-operative rehabilitation or standard rehabilitation plus virtual Cognitive Behavioral Therapy modules delivered online. The study duration is expected to be two years.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 24 months after surgery, with measurements taken at 3, 6, 12, and 24 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Anterior Cruciate Ligament Recovery With Virtual Psychological Intervention
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Thomas Sean Lynch, MD · PRINCIPAL_INVESTIGATOR · Henry Ford Health System
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Number of patients who Return to Sport at time set-points3,6,12 and 24 months
Comparing number of patients who Return to sport, defined as return to pre-injury involvement in the patient's respective sport at 3, 6, 12, and 24 months in each trial group.
- Patient-Reported Outcome Measurement Information System (PROMIS) scores for Physical Function and Pain Interference3,6,12, and 24 months
Comparing in each trial group, A validated patient reported outcome instrument where 50 is the average reference score of the patient population and the standard deviation is 10. For PROMIS measures, higher scores equals more of the concept being measured (e.g., more Pain Interference, more Physical Function). Thus a score of 60 is one standard deviation above the average referenced population. This could be a desirable or undesirable outcome, depending upon the concept being measured.
- Patient Health Questionnaire-2 (PHQ-2) scores3,6,12, and 24 months
Avalidated depression screening questionnaire with 3 points or more meaning a positive screen
- ACL-Return to Sport after Injury (ACL-RSI) scores3,6,12 and 24 months
A validated scale to measure the psychological impact of returning to sport following ACLR. There are three domains: risk appraisal, confidence, and emotions. A total score between 0 and 100 is calculated by adding and averaging the scores for each item. Greater psychological preparation is indicated by higher scores.