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Completed

NCT Number: NCT06150118

The Effect of Cognitive Behavioral Therapy and Virtual Reality Use in Inured Athletes

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).

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Key information

Conditions

Re-injury Anxiety Anxiety Disorders Kinesiophobia Mental Disorders Phobic Disorders Poor Rehabilitation Adherence Poor Rehabilitation Self Efficacy Return to Sport

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hacettepe University

Ankara, 06800, Turkey (Türkiye)

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CBT+VR (Cognitive behavioral therapy and virtual reality)

Other

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.

Control (placebo) group

Behavioral

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.

VR (Virtual reality)

Behavioral

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.

CBT (Cognitive Behavioral Therapy)

Other

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.

Primary outcomes

  1. Re-Injury Anxiety Inventory (RIAI)

    Time frame: Through study completion, an average of 1 year

    This scale measures re-injury anxiety

  2. Sport Injury Rehabilitation Adherence Scale (SIRAS)

    Time frame: Through study completion, an average of 1 year

    This scale measures rehabilitation adherence

  3. Athletic Injury Self-Efficacy Questionnaire (AISEQ)

    Time frame: Through study completion, an average of 1 year

    This scale measures Self-Efficacy

  4. Tampa Scale for Kinesiophobia

    Time frame: Through study completion, an average of 1 year

    This scale measures kinesiophobia

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Collaborators

  • The Scientific and Technological Research Council of Turkey

Registry information

Official study title

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

Acronym: CBT+VR

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Nov 29, 2023
Registry last updated
Jan 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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