Anterior Cruciate Ligament Recovery With Virtual Psychological Intervention
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed 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.
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Secondary Endpoints
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Patient-Reported Outcome Measurement Information System (PROMIS) scores, a validated patient reported outcome instrument1
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Patient Health Questionnaire-2 (PHQ-2) scores, a validated depression screening questionnaire2
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ACL-Return to Sport after Injury (ACL-RSI) scores, a validated scale to measure the psychological impact of returning to sport following ACLR3
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Post-operative opioid usage
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Utilization of additional counseling options (i.e., referral to behavioral health services)
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| No Intervention: Standard Post-Operative Rehabilitation No intervention, patients will receive the standard level of care. |
|
| Active Comparator: Virtual Psychological Intervention 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
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.
|
Outcome Measures
Primary Outcome Measures
- Return to Sport [3,6,12 and 24 months]
Return to sport, defined as return to pre-injury involvement in the patient's respective sport at 3, 6, 12, and 24 months.
- Patient-Reported Outcome Measurement Information System (PROMIS) scores [3,6,12, and 24 months]
A validated patient reported outcome instrument
- Patient Health Questionnaire-2 (PHQ-2) scores [3,6,12, and 24 months]
a validated depression screening questionnaire
- ACL-Return to Sport after Injury (ACL-RSI) scores [3,6,12 and 24 months]
a validated scale to measure the psychological impact of returning to sport following ACLR
Secondary Outcome Measures
- Post-operative opioid usage [0-24 months post-operatively]
the amount of usage of opioid medication post-operatively
- Utilization of additional counseling options (i.e., referral to behavioral health services) [0-24 months post-operatively]
Utilization of additional counseling options (i.e., referral to behavioral health services)
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients over the age of 12 with ACL injuries undergoing ACLR with a Henry Ford Sports Orthopedic Surgeon
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First time ACLR on the injured knee
Exclusion Criteria:
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Patients undergoing revision ACL surgery
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Concomitant posterior cruciate ligament injury of the involved knee
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Systemic or local infection pre-operatively
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Systemic administration of any type of corticosteroid or immunosuppressive agents within 30 days of surgery
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History of rheumatoid arthritis, inflammatory arthritis, or autoimmune diseases
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Pregnancy
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Henry Ford Health System
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 16012