Anterior Cruciate Ligament Recovery With Virtual Psychological Intervention
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age13+
SponsorHenry Ford Health System
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Virtual Psychological Intervention: Cognitive Behavioral Therapy
BehavioralAn 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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Standard Post-Operative RehabilitationNo intervention 0 interventions
Group B: Virtual Psychological InterventionActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Number of patients who Return to Sport at time set-points
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.
Time frame
3,6,12 and 24 months2
Patient-Reported Outcome Measurement Information System (PROMIS) scores for Physical Function and Pain Interference
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.
Time frame
3,6,12, and 24 months3
Patient Health Questionnaire-2 (PHQ-2) scores
Avalidated depression screening questionnaire with 3 points or more meaning a positive screen
Time frame
3,6,12, and 24 months4
ACL-Return to Sport after Injury (ACL-RSI) scores
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.
Time frame
3,6,12 and 24 monthsSecondary outcomes
1
Post-operative opioid usage
the amount of usage of opioid medication post-operatively
Time frame
0-24 months post-operatively2
Number of patients with Utilization of additional counseling options (i.e., referral to behavioral health services)
Utilization of additional counseling options (i.e., referral to behavioral health services)
Time frame
0-24 months post-operativelySponsors and contacts
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Source ClinicalTrials.gov