Anterior Cruciate Ligament Recovery With Virtual Psychological Intervention

Depression Clinical Trial

Official title: Randomized Control Trial of the Impact of a Virtual Psychological Intervention on the Outcomes of ACLR

Status Not yet recruiting

Clinical Trial Summary

To our knowledge, no studies have compared a virtual psychological intervention (VPI) to standard care in a randomized control trial format. We believe virtual administration of psychological CBT modules will be an accessible and convenient vehicle to improve ACLR outcomes. The purpose of our study is to apply and assess the outcomes of ACLR patients after undergoing VPI in comparison to a control cohort. We hypothesize that ACLR patients in the VPI cohort will have improved return to sport and post operative outcomes compared to controls. This study is a parallel arm prospective randomized-controlled trial. The expected duration of the study is two years. Trial eligibility criteria are as follows: patients over the age of 12 undergoing first time ACLR with a HFH Sports Orthopedic surgeon.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. Outcomes measured willl include return to sport at 3, 6, 12 and 24 months, PROMIS scores, PHQ-2 scores, ACL-RSI scores, post-op opioid usage.

Clinical Trial Description

Design

This study is a parallel arm prospective randomized-controlled trial. The expected duration of the study is two years. Trial eligibility criteria are as follows: patients over the age of 12 undergoing first time ACLR with a HFH Sports Orthopedic surgeon.

Randomization

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.

Treatment

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.

Outcomes

Demographic information and additional protected health information will be handled securely in a REDCap database. Pre-operative PROMIS and PHQ-2 scores will be obtained for both groups via electronic medical record abstraction. Primary and secondary endpoints are as follows:

• Primary Endpoint

o Return to sport, defined as return to pre-injury involvement in the patient's respective sport at 3, 6, 12, and 24 months.

• Secondary Endpoints

• Patient-Reported Outcome Measurement Information System (PROMIS) scores, a validated patient reported outcome instrument1

• Patient Health Questionnaire-2 (PHQ-2) scores, a validated depression screening questionnaire2

• 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

• Utilization of additional counseling options (i.e., referral to behavioral health services) ;

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Injuries
• Depression
• Mental Health Issue

• NCT number: NCT05965310
• Study type: Interventional
• Source: Henry Ford Health System
• Contact: Brittaney Pratt
• Phone: 8502842125
• Email: bpratt1@hfhs.org
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 20, 2023
• Completion date: December 31, 2024