Clinical trial NCT05965310: Anterior Cruciate Ligament Recovery With Virtual Psychological Intervention
Official title: Randomized Control Trial of the Impact of a Virtual Psychological Intervention on the Outcomes of ACLR
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depression
Anterior Cruciate Ligament Injuries
Mental Health Issue
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
First posted: 2023-07-28
Enrollment: 60
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is a parallel arm prospective randomized-controlled trial.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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)

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

Primary outcomes:
measure: Number of patients who Return to Sport at time set-points
timeFrame: 3,6,12 and 24 months
measure: Patient-Reported Outcome Measurement Information System (PROMIS) scores for Physical Function and Pain Interference
timeFrame: 3,6,12, and 24 months
measure: Patient Health Questionnaire-2 (PHQ-2) scores
timeFrame: 3,6,12, and 24 months
measure: ACL-Return to Sport after Injury (ACL-RSI) scores
timeFrame: 3,6,12 and 24 months
Secondary outcomes:
measure: Post-operative opioid usage
timeFrame: 0-24 months post-operatively
measure: Number of patients with Utilization of additional counseling options (i.e., referral to behavioral health services)
timeFrame: 0-24 months post-operatively
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
Study officials:
affiliation: Henry Ford Health System
name: Thomas Sean Lynch, MD
role: PRINCIPAL_INVESTIGATOR
References: