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Behavioral Intervention

Virtual Psychological Intervention for ACL Injury

N/A

Recruiting

Led By Thomas Sean Lynch, MD

Research Sponsored by Henry Ford Health System

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3,6,12 and 24 months

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to compare the outcomes of patients undergoing ACL reconstruction surgery who receive a virtual psychological intervention (VPI) in addition to standard care, with those who receive only standard care. The researchers want

Who is the study for?

This trial is for individuals over the age of 12 who have an ACL injury and are undergoing their first ACL reconstruction with a Henry Ford Sports Orthopedic Surgeon. It's not suitable for those who don't meet these specific conditions.

What is being tested?

The study is testing if virtual cognitive behavioral therapy (CBT) can improve recovery outcomes after ACL surgery, compared to standard care alone. Participants will be randomly assigned to either receive virtual CBT modules plus standard care or just the standard post-surgery care.

What are the potential side effects?

Since this intervention involves psychological support rather than medication, typical drug side effects aren't expected. However, participants may experience emotional discomfort or distress as they engage with CBT content.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am over 12 and having ACL surgery with a Henry Ford Sports Orthopedic Surgeon.

Select...

This is my first ACL reconstruction on the injured knee.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3,6,12 and 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3,6,12 and 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3,6,12 and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

ACL-Return to Sport after Injury (ACL-RSI) scores

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

Patient Health Questionnaire-2 (PHQ-2) scores

+1 more

Secondary study objectives

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

Post-operative opioid usage

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: Standard Post-Operative RehabilitationActive Control1 Intervention

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

Group II: Virtual Psychological InterventionActive Control1 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.

0 / 2Eligibility criteria met