Recruiting

Virtual Psychological Intervention

Sponsor:

Henry Ford Health System

Code:

NCT05965310

Conditions

Depression

Anterior Cruciate Ligament Injuries

Mental Health Issue

Eligibility Criteria

Sex: All

Age: 13+

Healthy Volunteers: Not accepted

Interventions

Virtual Psychological Intervention: Cognitive Behavioral Therapy

Study Details

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

Study ID

NCT05965310

Start date

Sep 1, 2023

Status verified date

Jun, 2026

Completion date

Mar, 2027

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 13+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

  • Number of patients who Return to Sport at time set-points [ Time Frame: 3,6,12 and 24 months ]
  • Patient-Reported Outcome Measurement Information System (PROMIS) scores for Physical Function and Pain Interference [ Time Frame: 3,6,12, and 24 months ]
  • Patient Health Questionnaire-2 (PHQ-2) scores [ Time Frame: 3,6,12, and 24 months ]
  • ACL-Return to Sport after Injury (ACL-RSI) scores [ Time Frame: 3,6,12 and 24 months ]

Central Contacts and Locations

Central contacts

Maxim Jani, BS

2488240579mjani1@hfhs.org

Locations

Henry Ford Health System

Recruiting

Detroit, Michigan, United States, 48202

Contacts

Maxim Jani, BS

2488240579mjani1@hfhs.org

More Information

Sponsor

Henry Ford Health System

Last update posted

Aug 27, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Henry Ford Health System on 2026-08-27.