The Effect of Cognitive Behavioral Therapy and Virtual Reality Use in Inured Athletes (CBT+VR)

January 12, 2026 updated by: Hande Turkeri Bozkurt, Hacettepe University

The Effect of Cognitive Behavioral Therapy and Virtual Reality Use in Supporting Physical Rehabilitation After Anterior Cruciate Ligament (ACL) Operation: A Parallel-Arm Randomized Controlled Trial

In this study, which aimed to develop a Cognitive Behavioral Therapy (CBT) protocol enriched with Virtual Reality (VR) to address the psychological responses that arise after ACL surgery, and to examine the effectiveness of this protocol. The effectiveness of the protocol was assessed using pre-test, post-test, and two follow-up measurements with the Re-Injury Anxiety Inventory (RIAI), the Sport Injury Rehabilitation Adherence Scale (SIRAS), the Tampa Scale for Kinesiophobia (TSK), the Athletic Injury Self-Efficacy Questionnaire (AISEQ), the Return to Sport After Serious Injury Questionnaire (RSSIQ), and the Anterior Cruciate Ligament Return to Sport Scale (ACL-RSI). Anxiety levels during VR exposure sessions were measured through biofeedback and the Subjective Units of Distress Scale (SUDS).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In this study, which aimed to develop a Cognitive Behavioral Therapy (CBT) protocol enriched with Virtual Reality (VR) to address the psychological responses that arise after ACL surgery, and to examine the effectiveness of this protocol. The protocol was developed in 5 stages and a randomized controlled trial was conducted with 60 athletes to test its effectiveness. The study consisted of 3 experimental and 2 control groups. One of the control group was a plasebo control group.The effectiveness of the protocol was assessed using pre-test, post-test, and follow-up measurements with the Re-Injury Anxiety Inventory (RIAI), the Sport Injury Rehabilitation Adherence Scale (SIRAS), the Tampa Scale for Kinesiophobia (TSK), the Athletic Injury Self-Efficacy Questionnaire (AISEQ), the Return to Sport After Serious Injury Questionnaire (RSSIQ), and the Anterior Cruciate Ligament Return to Sport Scale (ACL-RSI). Anxiety levels during VR exposure sessions were measured through biofeedback and the Subjective Units of Distress Scale (SUDS).

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Volunteering to participate in the study
  • Have had an ACL injury operation
  • Be between the ages of 18 and 45
  • To be a professional athlete in Turkish leagues
  • Being an athlete in football, volleyball, and basketball

Exclusion Criteria:

  • Having a discomfort that prevents participants from participating in VR sessions (panic attack, epilepsy, etc.)
  • Having decided to quit sports even if participants will continue rehabilitation after the operation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control
Behavioral: Control (placebo) group
The investigators are testing whether the placebo control protocol is effective on re-injury anxiety, kinesiophobia, self-efficacy, and adherence problems in athletes who have undergone ACL surgery.
Experimental: CBT+VR (Cognitive behavioral therapy and virtual reality)
Other: CBT+VR (Cognitive behavioral therapy and virtual reality)
The investigators are testing whether this intervention protocol is effective on re-injury anxiety, kinesiophobia, self-efficacy, and adherence problems in athletes who have undergone ACL surgery.
Experimental: VR (Virtual reality)
Behavioral: VR (Virtual reality)
The investigators are testing whether this intervention protocol is effective on re-injury anxiety, kinesiophobia, self-efficacy, and adherence problems in athletes who have undergone ACL surgery.
No Intervention: Control Group
This arm have no intervention during the research. They only had been followed up by researchers
Experimental: CBT (Cognitive Behavioral Therapy)
Other: CBT (Cognitive Behavioral Therapy)
The investigators are testing whether this intervention protocol is effective on re-injury anxiety, kinesiophobia, self-efficacy, and adherence problems in athletes who have undergone ACL surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Re-Injury Anxiety Inventory (RIAI)
Time Frame: Through study completion, an average of 1 year
This scale measures re-injury anxiety
Through study completion, an average of 1 year
Sport Injury Rehabilitation Adherence Scale (SIRAS)
Time Frame: Through study completion, an average of 1 year
This scale measures rehabilitation adherence
Through study completion, an average of 1 year
Athletic Injury Self-Efficacy Questionnaire (AISEQ)
Time Frame: Through study completion, an average of 1 year
This scale measures Self-Efficacy
Through study completion, an average of 1 year
Tampa Scale for Kinesiophobia
Time Frame: Through study completion, an average of 1 year
This scale measures kinesiophobia
Through study completion, an average of 1 year
Return to Sport After Serious Injury Questionnaire (RSSIQ)
Time Frame: Through study completion, an average of 1 year
This scale was used to assess whether athletes were psychologically ready to return to sport.
Through study completion, an average of 1 year
Anterior Cruciate Ligament Return to Sport Scale (ACL-RSI)
Time Frame: Through study completion, an average of 1 year
This scale was used to assess whether athletes were psychologically ready to return to sport from ACL surgery.
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hacettepe University

Collaborators

The Scientific and Technological Research Council of Turkey

Investigators

  • Study Director: Ziya Koruç, PhD, Hacettepe University
  • Study Director: Britton W. Brewer, PhD, Springfield College

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 5, 2023

Primary Completion (Actual)

February 7, 2025

Study Completion (Actual)

February 7, 2025

Study Registration Dates

First Submitted

November 17, 2023

First Submitted That Met QC Criteria

November 28, 2023

First Posted (Actual)

November 29, 2023

Study Record Updates

Last Update Posted (Estimated)

January 14, 2026

Last Update Submitted That Met QC Criteria

January 12, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 121K248

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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