Re-injury AnxietyCBT+VRNCT06150118
The Effect of Cognitive Behavioral Therapy and Virtual Reality Use in Inured Athletes
A study testing CBT+VR (Cognitive behavioral therapy and virtual reality), VR (Virtual reality) and CBT (Cognitive Behavioral Therapy) in people with Re-injury Anxiety and Kinesiophobia, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Re-injury Anxiety, Kinesiophobia, Poor Rehabilitation Adherence
- What is being tested?
- CBT+VR (Cognitive behavioral therapy and virtual reality), VR (Virtual reality) and CBT (Cognitive Behavioral Therapy)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Apr 2023to 7 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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).
Read the 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).
- Conditions
- Re-injury Anxiety, Kinesiophobia, Poor Rehabilitation Adherence, Poor Rehabilitation Self Efficacy, Return to Sport
- Being tested
- CBT+VR (Cognitive behavioral therapy and virtual reality), Control (placebo) group, VR (Virtual reality), CBT (Cognitive Behavioral Therapy)
- Keywords
- Re-injury anxiety, Adherence, Self-efficacy, Kinesiophobia, psychological readiness to return to sport
- Medical subject headings
- Kinesiophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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) groupBehavioural
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)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| CBT+VR (Cognitive behavioral therapy and virtual reality) | Experimental | Not described Receives: Other: CBT+VR (Cognitive behavioral therapy and virtual reality) |
| Control | Placebo comparator | Not described Receives: Behavioral: Control (placebo) group |
| Control Group | No intervention | This arm have no intervention during the research. They only had been followed up by researchers |
| CBT (Cognitive Behavioral Therapy) | Experimental | Not described Receives: Other: CBT (Cognitive Behavioral Therapy) |
| VR (Virtual reality) | Experimental | Not described Receives: Behavioral: VR (Virtual reality) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Re-Injury Anxiety Inventory (RIAI)
This scale measures re-injury anxiety
Measured: Through study completion, an average of 1 year
Sport Injury Rehabilitation Adherence Scale (SIRAS)
This scale measures rehabilitation adherence
Measured: Through study completion, an average of 1 year
Athletic Injury Self-Efficacy Questionnaire (AISEQ)
This scale measures Self-Efficacy
Measured: Through study completion, an average of 1 year
Tampa Scale for Kinesiophobia
This scale measures kinesiophobia
Measured: Through study completion, an average of 1 year
Anterior Cruciate Ligament Return to Sport Scale (ACL-RSI)
This scale was used to assess whether athletes were psychologically ready to return to sport from ACL surgery.
Measured: Through study completion, an average of 1 year
Return to Sport After Serious Injury Questionnaire (RSSIQ)
This scale was used to assess whether athletes were psychologically ready to return to sport.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2023
- Study start5 Apr 2023
- Primary completion7 Feb 2025
- Study completion7 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Re-injury AnxietyStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Principal investigator, Hande Turkeri Bozkurt, Hacettepe University
- Investigators
- Ziya Koruç, PhD, Study director, Hacettepe UniversityBritton W. Brewer, PhD, Study director, Springfield College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06150118
- Sponsor's protocol ID
- 121K248
- Acronym
- CBT+VR
- Status last verified
- Aug 2026
- First submitted
- 17 Nov 2023
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06150118
- Acronym / sponsor ID
- CBT+VR / 121K248
- Conditions
- Re-injury Anxiety, Kinesiophobia, Poor Rehabilitation Adherence, Poor Rehabilitation Self Efficacy, Return to Sport
- Keywords
- Re-injury anxiety, Adherence, Self-efficacy, Kinesiophobia, psychological readiness to return to sport
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 5 Apr 2023 (actual)
- Primary completion
- 7 Feb 2025 (actual)
- Study completion
- 7 Feb 2025 (actual)
- First posted
- 29 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| CBT+VR (Cognitive behavioral therapy and virtual reality) | Experimental | Other: CBT+VR (Cognitive behavioral therapy and virtual reality) |
| Control | Placebo comparator | Behavioral: Control (placebo) group |
| Control Group | No intervention | –This arm have no intervention during the research. They only had been followed up by researchers |
| CBT (Cognitive Behavioral Therapy) | Experimental | Other: CBT (Cognitive Behavioral Therapy) |
| VR (Virtual reality) | Experimental | Behavioral: VR (Virtual reality) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | CBT+VR (Cognitive behavioral therapy and virtual reality) |
| Control (placebo) groupThe 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. | Behavioural | Control |
| 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. | Behavioural | VR (Virtual reality) |
| 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. | Other | CBT (Cognitive Behavioral Therapy) |
Primary outcome
Re-Injury Anxiety Inventory (RIAI)
Time frame: Through study completion, an average of 1 year
This scale measures re-injury anxiety
Sport Injury Rehabilitation Adherence Scale (SIRAS)
Time frame: Through study completion, an average of 1 year
This scale measures rehabilitation adherence
Athletic Injury Self-Efficacy Questionnaire (AISEQ)
Time frame: Through study completion, an average of 1 year
This scale measures Self-Efficacy
Tampa Scale for Kinesiophobia
Time frame: Through study completion, an average of 1 year
This scale measures kinesiophobia
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Re-injury Anxiety
Not yet recruiting
Binaural Beats Stimulation on the Autonomic Nervous System (ANS), Kinesiophobia and Fitness Levels in Professional Athletes With Musculoskeletal (MSK) Injuries
Kinesiophobia (Fear of Movement), Musculoskeletal Injuries
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ziya Koruç, PhD study director
Hacettepe University
Britton W. Brewer, PhD study director
Springfield College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBT+VR (Cognitive behavioral therapy and virtual reality), VR (Virtual reality) and CBT (Cognitive Behavioral Therapy) in people with Re-injury Anxiety and Kinesiophobia, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Re-Injury Anxiety Inventory (RIAI) (time frame: Through study completion, an average of 1 year). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.