Anterior Cruciate Ligament Recovery With Virtual Psychological Intervention

NCT05965310 | Recruiting

• 1 other identifier: 16012
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Anterior Cruciate Ligament Injuries; Mental Health Issue

Outcome Measures

Primary Outcomes (4)

• Number of patients who Return to Sport at time set-points

  Comparing number of patients who Return to sport, defined as return to pre-injury involvement in the patient's respective sport at 3, 6, 12, and 24 months in each trial group.

  3,6,12 and 24 months

• Patient-Reported Outcome Measurement Information System (PROMIS) scores for Physical Function and Pain Interference

  Comparing in each trial group, A validated patient reported outcome instrument where 50 is the average reference score of the patient population and the standard deviation is 10. For PROMIS measures, higher scores equals more of the concept being measured (e.g., more Pain Interference, more Physical Function). Thus a score of 60 is one standard deviation above the average referenced population. This could be a desirable or undesirable outcome, depending upon the concept being measured.

  3,6,12, and 24 months

• Patient Health Questionnaire-2 (PHQ-2) scores

  Avalidated depression screening questionnaire with 3 points or more meaning a positive screen

  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. There are three domains: risk appraisal, confidence, and emotions. A total score between 0 and 100 is calculated by adding and averaging the scores for each item. Greater psychological preparation is indicated by higher scores.

  3,6,12 and 24 months

Secondary Outcomes (2)

• Post-operative opioid usage

  0-24 months post-operatively

• Number of patients with Utilization of additional counseling options (i.e., referral to behavioral health services)

  0-24 months post-operatively

Study Arms (2)

Standard Post-Operative Rehabilitation

NO INTERVENTION

No intervention, patients will receive the standard level of care.

Virtual Psychological Intervention

ACTIVE COMPARATOR

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

Interventions

Virtual Psychological Intervention: Cognitive Behavioral Therapy BEHAVIORAL

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.

Virtual Psychological Intervention

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Henry Ford Health System: lead

Study Sites (1)

Henry Ford Health System

Detroit, Michigan, 48202, United States

RECRUITING

MeSH Terms

Conditions

Depression; Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Knee Injuries; Leg Injuries; Wounds and Injuries

Study Officials

• Thomas Sean Lynch, MD

  Henry Ford Health System

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brittaney Pratt

CONTACT

8502842125; bpratt1@hfhs.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Model Details: This study is a parallel arm prospective randomized-controlled trial.

Study Record Dates

• First Submitted: July 20, 2023
• First Posted: July 28, 2023
• Study Start: September 1, 2023
• Primary Completion: April 30, 2025
• Study Completion: December 31, 2025
• Last Updated: December 5, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)