Anterior Cruciate Ligament Recovery With Virtual Psychological Intervention
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Virtual Psychological Intervention: Cognitive Behavioral Therapy.
- Who it may be relevant to
- Registry conditions: Depression, Anterior Cruciate Ligament Injuries, Mental Health Issue. Basic parameters: from 13 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Randomized Control Trial of the Impact of a Virtual Psychological Intervention on the Outcomes of ACLR
Overview
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.
Detailed description
This study is a parallel arm prospective randomized-controlled trial. The expected duration of the study is two years. 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. Trial eligibility criteria are as follows: patients over the age of 12 undergoing first time ACLR with a HFH Sports Orthopedic surgeon. Eligible participants will be randomized using computerized random number generation into two groups: Group A and Group B. Both groups will receive the same standard post-operative rehabilitation protocol. 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. Each session is designed to provide patients with different CBT strategies to augment their recovery. Sessions will be delivered virtually by trained health professionals. Participants in Group B will receive standard-of-care rehabilitation only. Demographic information and additional protected health information will be handled securely in a securedatabase. Pre-operative PROMIS and PHQ-2 scores will be obtained for both groups via electronic medical record abstraction. Primary endpoints are as follows: Return to sport, defined as return to pre-injury involvement in the patient's respective sport at 3, 6, 12, and 24 months. Secondary outcomes are as follows: Patient-Reported Outcome Measurement Information System (PROMIS) scores, a validated patient reported outcome instrument, Patient Health Questionnaire-2 (PHQ-2) scores, a validated depression screening questionnaire, ACL-Return to Sport after Injury (ACL-RSI) scores, a validated scale to measure the psychological impact of returning to sport following ACLR3, Post-operative opioid usage and Utilization of additional counseling options (i.e., referral to behavioral health services)
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]
- Patient-Reported Outcome Measurement Information System (PROMIS) scores for Physical Function and Pain Interference [Time frame: 3,6,12, and 24 months]
- Patient Health Questionnaire-2 (PHQ-2) scores [Time frame: 3,6,12, and 24 months]
- ACL-Return to Sport after Injury (ACL-RSI) scores [Time frame: 3,6,12 and 24 months]
Secondary outcome measures (2)
- Post-operative opioid usage [Time frame: 0-24 months post-operatively]
- Number of patients with Utilization of additional counseling options (i.e., referral to behavioral health services) [Time frame: 0-24 months post-operatively]
Eligibility criteria
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
- Pregnancy
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- Henry Ford Health System — Detroit
Identifiers
NCT: NCT05965310 · 16012