Ignite Creation Date:
2024-05-06 @ 7:19 PM
Last Modification Date:
2024-10-26 @ 3:04 PM
Study NCT ID:
NCT05965310
Status:
RECRUITING
Last Update Posted:
2023-07-28
First Post:
2023-07-20
Brief Title:
Anterior Cruciate Ligament Recovery With Virtual Psychological Intervention
Sponsor:
Henry Ford Health System
Organization:
Henry Ford Health System
Study Overview
Official Title:
Randomized Control Trial of the Impact of a Virtual Psychological Intervention on the Outcomes of ACLR
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 patients 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 ie referral to behavioral health services
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None