Anterior Cruciate Ligament Recovery With Virtual Psychological Intervention

Part of paid clinical trials in Detroit, Michigan.

Sponsor
Henry Ford Health System
Study ID
NCT05965310
Status
Recruiting
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Conditions

  • Anterior Cruciate Ligament Injuries
  • Depression
  • Mental Health Issue

Eligibility Criteria

Sex
ALL
Age
13 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Virtual Psychological Intervention: Cognitive Behavioral Therapy — 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.

Study Details

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.

Key Dates

Start date
Sep 1, 2023
Status verified
Dec 2024
Primary completion
Apr 30, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

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.

Primary Outcome Measure

Number of patients who Return to Sport at time set-points [ Time Frame: 3,6,12 and 24 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Henry Ford Health SystemDetroitMichigan48202
Brittaney Pratt
[email protected]

Find similar trials in Detroit, MI

By condition
Depression
By specialty
PsychiatryMental healthBehavioral health
By research site
Henry Ford Health System· Detroit, MI

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