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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05965310
• Other study ID #: 16012
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 20, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: July 2023
• Source: Henry Ford Health System
• Contact: Brittaney Pratt
• Phone: 8502842125
• Email: bpratt1[@]hfhs.org
• Is FDA regulated: No
• Study type: Interventional

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.

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)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Injuries
• Depression
• Mental Health Issue

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Henry Ford Health System

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Patient-Reported Outcome Measurement Information System (PROMIS) scores	A validated patient reported outcome instrument	3,6,12, and 24 months
Primary	Patient Health Questionnaire-2 (PHQ-2) scores	a validated depression screening questionnaire	3,6,12, and 24 months
Primary	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	Post-operative opioid usage	the amount of usage of opioid medication post-operatively	0-24 months post-operatively
Secondary	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