Anterior Cruciate Ligament Recovery With Virtual Psychological Intervention

Официальное название

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

Обзор

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.

Подробное описание

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)

Вмешательства

• Поведенческое 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.

Первичные конечные точки

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

Вторичные конечные точки (2)

• Post-operative opioid usage [Срок оценки: 0-24 months post-operatively]
• Number of patients with Utilization of additional counseling options (i.e., referral to behavioral health services) [Срок оценки: 0-24 months post-operatively]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• Henry Ford Health System — Detroit

Идентификаторы

NCT: NCT05965310 · 16012

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗