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Anterior Cruciate Ligament Recovery With Virtual Psychological Intervention

NCT ID: NCT05965310

Last Updated: 2024-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-01

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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This study is a parallel arm prospective randomized-controlled trial. The expected duration of the study is two years. 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. Trial eligibility criteria are as follows: patients over the age of 12 undergoing first time ACLR with a HFH Sports Orthopedic surgeon. Eligible participants will be randomized using computerized random number generation into two groups: Group A and Group B. Both groups will receive the same standard post-operative rehabilitation protocol. 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. Each session is designed to provide patients with different CBT strategies to augment their recovery. Sessions will be delivered virtually by trained health professionals. Participants in Group B will receive standard-of-care rehabilitation only. Demographic information and additional protected health information will be handled securely in a securedatabase. Pre-operative PROMIS and PHQ-2 scores will be obtained for both groups via electronic medical record abstraction. Primary endpoints are as follows: Return to sport, defined as return to pre-injury involvement in the patient's respective sport at 3, 6, 12, and 24 months. Secondary outcomes are as follows: Patient-Reported Outcome Measurement Information System (PROMIS) scores, a validated patient reported outcome instrument, Patient Health Questionnaire-2 (PHQ-2) scores, a validated depression screening questionnaire, ACL-Return to Sport after Injury (ACL-RSI) scores, a validated scale to measure the psychological impact of returning to sport following ACLR3, Post-operative opioid usage and Utilization of additional counseling options (i.e., referral to behavioral health services)

Conditions

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Depression Anterior Cruciate Ligament Injuries Mental Health Issue

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This study is a parallel arm prospective randomized-controlled trial.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Caregivers

Study Groups

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Standard Post-Operative Rehabilitation

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

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type ACTIVE_COMPARATOR

Virtual Psychological Intervention: Cognitive Behavioral Therapy

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Henry Ford Health System

OTHER

Sponsor Role lead

Responsible Party

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Thomas Lynch

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Thomas Sean Lynch, MD

Role: PRINCIPAL_INVESTIGATOR

Henry Ford Health System

Locations

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Henry Ford Health System

Detroit, Michigan, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Brittaney Pratt

Role: CONTACT

Phone: 8502842125

Email: [email protected]

Facility Contacts

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Brittaney Pratt

Role: primary

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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16012

Identifier Type: -

Identifier Source: org_study_id