Actively Recruiting

Phase Not Applicable
Age: 13Years +
All Genders
ID05965310

Randomized Controlled Trial of Virtual Cognitive Behavioral Therapy to Improve Outcomes After ACL Reconstruction Surgery

Led by Henry Ford Health System · Updated on 2024-12-05

60

Participants Needed

1

Research Sites

35 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the impact of a virtual psychological intervention on recovery outcomes for patients undergoing Anterior Cruciate Ligament Reconstruction (ACLR) surgery. This randomized controlled trial aims to determine whether virtual cognitive behavioral therapy (CBT) modules, delivered alongside standard care, can improve return to sport and postoperative recovery compared to standard care alone. The study focuses on patients over age 12 undergoing their first ACLR surgery with a specific orthopedic surgeon. Participants will be randomly assigned to one of two groups. One group receives standard post-operative rehabilitation only, while the other group receives the same rehabilitation plus access to asynchronous virtual CBT modules before and after surgery. These virtual sessions are designed to provide strategies to support recovery and are delivered by trained health professionals. The study is expected to last two years, with both groups following the same rehabilitation plan. Throughout the study, participants will be assessed at 3, 6, 12, and 24 months after surgery. Researchers will collect data including return to sport status, physical function and pain interference scores, depression screening results, psychological impact of returning to sport, opioid use after surgery, and use of additional counseling services. Protected health information will be securely managed, and all assessments will help evaluate the benefits of adding virtual psychological support to ACLR recovery.

CONDITIONS

Brief Title

Anterior Cruciate Ligament Recovery With Virtual Psychological Intervention

Who Can Participate

Age: 13Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients over the age of 12 with ACL injuries undergoing ACL reconstruction surgery with a Henry Ford Sports Orthopedic Surgeon
  • First time ACL reconstruction on the injured knee
Not Eligible

You will not qualify if you...

  • Patients undergoing revision ACL surgery
  • Concomitant posterior cruciate ligament injury of the involved knee
  • Systemic or local infection before surgery
  • Systemic administration of corticosteroids or immunosuppressive agents within 30 days before surgery
  • History of rheumatoid arthritis, inflammatory arthritis, or autoimmune diseases
  • Pregnancy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Surgery day and initial recovery period

Participants undergo ACL reconstruction surgery and receive standard post-operative care.

1 surgery day visit and initial hospital stay

Treatment

Duration - Up to 24 months post-surgery

Participants receive standard post-operative rehabilitation. Participants in the treatment group also complete virtual cognitive behavioral therapy modules before and after surgery to support recovery.

Multiple virtual sessions for cognitive behavioral therapy depending on group assignment; standard rehabilitation visits as scheduled

Follow-up

Duration - Up to 24 months post-surgery

Participants are assessed for return to sport and patient-reported outcomes including physical function, pain, psychological impact, and opioid usage.

Visits at 3, 6, 12, and 24 months post-surgery

Trial Site Locations

Total: 1 location

1

Henry Ford Health System

Detroit, Michigan, United States, 48202

Actively Recruiting

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Research Team

B

Brittaney Pratt

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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