Anterior Cruciate Ligament Recovery With Virtual Psychological Intervention

Study Overview
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Brief Summary
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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.

Detailed Description
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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)

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

Conditions
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Depression, Anterior Cruciate Ligament Injuries, Mental Health Issue

Intervention / Treatment
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* Behavioral: Virtual Psychological Intervention: Cognitive Behavioral Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 13 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This study is a parallel arm prospective randomized-controlled trial.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard Post-Operative Rehabilitation<br>No intervention, patients will receive the standard level of care. | |
| Active Comparator: Virtual Psychological Intervention<br>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. | Behavioral: Virtual Psychological Intervention: Cognitive Behavioral Therapy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Return to Sport | Return to sport, defined as return to pre-injury involvement in the patient's respective sport at 3, 6, 12, and 24 months. | 3,6,12 and 24 months | 
| Patient-Reported Outcome Measurement Information System (PROMIS) scores | A validated patient reported outcome instrument | 3,6,12, and 24 months | 
| Patient Health Questionnaire-2 (PHQ-2) scores | a validated depression screening questionnaire | 3,6,12, and 24 months | 
| ACL-Return to Sport after Injury (ACL-RSI) scores | a validated scale to measure the psychological impact of returning to sport following ACLR | 3,6,12 and 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative opioid usage | the amount of usage of opioid medication post-operatively | 0-24 months post-operatively | 
| Utilization of additional counseling options (i.e., referral to behavioral health services) | Utilization of additional counseling options (i.e., referral to behavioral health services) | 0-24 months post-operatively |