Recruiting

Anterior Cruciate Ligament Recovery With Virtual Psychological Intervention

ClinicalTrials.gov IDNCT05965310

PhaseNA

Enrollment60

SponsorHenry Ford Health System

Age13 Years

SexALL

I'm interested View official listing

Conditions studied

Depression, Anterior Cruciate Ligament Injuries, Mental Health Issue

About this study

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 outcomes

Number of patients who Return to Sport at time set-points (3,6,12 and 24 months)
Patient-Reported Outcome Measurement Information System (PROMIS) scores for Physical Function and Pain Interference (3,6,12, and 24 months)
Patient Health Questionnaire-2 (PHQ-2) scores (3,6,12, and 24 months)
ACL-Return to Sport after Injury (ACL-RSI) scores (3,6,12 and 24 months)

Eligibility information

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

Study locations

Henry Ford Health System, Detroit, Michigan 48202 United States

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.