NCT05965310 · Henry Ford Health System
Anterior Cruciate Ligament Recovery With Virtual Psychological Intervention
What this study is about
The goal of this parallel treatment group$1 forward-looking randomly assigned control trial study is to compare outcomes in Anterior Cruciate Ligament Reconstruction (ACLR) Surgery patients after exposure to a virtual psychological intervention (VPI) versus standard care.
View original scientific description
The goal of this parallel arm prospective randomized control trial study is to compare outcomes in Anterior Cruciate Ligament Reconstruction (ACLR) Surgery patients after exposure to a virtual psychological intervention (VPI) versus standard care. The main question the investigators are asking is if virtual administration of psychological CBT modules will be an accessible and convenient vehicle to improve ACLR outcomes. Participants will be placed either into a treatment group receiving virtual modules of cognitive behavioral therapy in addition to standard of care ACLR surgery or the control group receiving only the standard of care ACLR surgery. The investigators hypothesize that ACLR patients in the VPI cohort will have improved return to sport and post operative outcomes compared to controls.
Interventions
BEHAVIORAL
Virtual Psychological Intervention: Cognitive Behavioral Therapy
An asynchronous course of pre- and post-operative CBT modules (VPI) will be delivered to patients in Group A as an adjuvant treatment to standard-of-care rehabilitation.
Primary outcome measures
Number of patients who Return to Sport at time set-points
Time frame: 3,6,12 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 Interference
Time frame: 3,6,12, 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) scores
Time frame: 3,6,12, and 24 months
Avalidated depression screening questionnaire with 3 points or more meaning a positive screen
ACL-Return to Sport after Injury (ACL-RSI) scores
Time frame: 3,6,12 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Patients over the age of 12 with ACL injuries undergoing ACLR with a Henry Ford Sports Orthopedic Surgeon
- First time ACLR on the injured knee
Exclusion criteria
- Patients undergoing revision ACL surgery
- Concomitant posterior cruciate ligament injury of the involved knee
- Systemic or local infection pre-operatively
- Systemic administration of any type of corticosteroid or immunosuppressive agents within 30 days of surgery
- History of rheumatoid arthritis, inflammatory arthritis, or autoimmune diseases
Where
- Detroit, Michigan
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 5, 2024 · Source of record for eligibility and locations