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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

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 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

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.

Find a Location

Who is running the clinical trial?

Henry Ford Health SystemLead Sponsor
309 Previous Clinical Trials
2,168,282 Total Patients Enrolled
1 Trials studying Anterior Cruciate Ligament Injury
62 Patients Enrolled for Anterior Cruciate Ligament Injury
Thomas Sean Lynch, MDPrincipal InvestigatorHenry Ford Health System
~0 spots leftby Sep 2024
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