Social Anxiety DisorderPhase 4NCT07192367
Comparison of the Effectiveness Level of Virtual Reality Exposure Therapy With Sertraline Treatment in Social Anxiety Disorder
A Phase 4 study testing Virtual Reality Exposure Therapy and Sertraline (Oral Antidepressant) in people with Social Anxiety Disorder, run by Emine Kanmaz at 1 site in Turkey (Türkiye).
Trial summary
This study compares two treatment approaches for adolescents and young adults with social anxiety. One group will participate in therapy sessions using a virtual reality headset, while the other group will receive sertraline, a commonly used medication for social anxiety. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Social Anxiety Disorder
- What is being tested?
- Virtual Reality Exposure Therapy and Sertraline (Oral Antidepressant)
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Nov 2024to Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- RESEARCH ARM:
- Applied to Kocaeli University Child and Adolescent Psychiatry Outpatient Clinic
- Have normal intelligence based on clinical observation
- Be between 12 and 17 years of age
- Have a diagnosis of SAD
- Have refused medication recommended for SAD
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- For SAD; are not currently receiving medical treatment
- Have received written consent to participate in the study from them and/or their first-degree relatives authorized to make decisions about them
- Have volunteered to participate in the study through an invitation poster presentation
- CONTROL ARM:
- 1 Applied to Kocaeli University Child and Adolescent Psychiatry Outpatient Clinic 2. Have normal intelligence based on clinical observation 3. Be between 12 and 17 years of age 4. Have a diagnosis of SAD 5. Have refused medication recommended for SAD 6. For SAD; are not currently receiving medical treatment 7. Have obtained written informed consent to participate in the study from them and/or their first-degree relatives authorized to make decisions about them 8. Have volunteered to participate in the study through an invitation poster presentation
- CONTROL ARM:
- 1 Applied to Kocaeli University Child and Adolescent Psychiatry Outpatient Clinic 2. Have normal intelligence based on clinical observation 3. Be between 12 and 17 years of age 4. Have a diagnosis of SAD 5. For SAD; Not currently receiving medical treatment 6. Volunteer 7. Written consent for participation in the study must be obtained from the patient and/or their first-degree relative authorized to make decisions about them.
- 8. Accept sertraline treatment, routinely used in outpatient clinic follow-ups for SAD, and volunteer for the study.
Who cannot join
- RESEARCH ARM:
- Substance use disorder
- Schizophrenia and bipolar disorder
- Autism spectrum disorder
- Cognitive disability
- Neurological disorder
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- Balance disorder
- Patients who have received SSRI treatment for SAD in the last 6 months
- CONTROL ARM:
- Substance use disorder
- Schizophrenia and bipolar disorder
- Autism spectrum disorder
- Cognitive disability
- Patients who have received SSRI treatment for SAD within the last 6 months -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Kocaeli University Hospital - Department of Child and Adolescent Psychiatry
Kocaeli, 41000
Emine Kayış, MD (Assistant Doctor in Child, +905557452890, eminekanmaz@gmail.com
Nursu Çakın Memik, MD, Prof.
About this study
This study compares two treatment approaches for adolescents and young adults with social anxiety. One group will participate in therapy sessions using a virtual reality headset, while the other group will receive sertraline, a commonly used medication for social anxiety. The goal is to see which treatment is more effective in reducing anxiety symptoms and improving daily functioning. The study will also look at how acceptable and safe these treatments are. A total of 56 participants will be enrolled at Kocaeli University, Department of Child and Adolescent Psychiatry.
Read the detailed description
Social anxiety disorder (SAD) is a common psychiatric condition that often begins in adolescence and causes significant impairment in academic, social, and occupational functioning. Although selective serotonin reuptake inhibitors (SSRIs) such as sertraline have demonstrated efficacy, many families and patients hesitate to use pharmacological treatments due to concerns about side effects and personal preferences. Virtual reality (VR)-based exposure therapy has emerged as a promising intervention by providing controlled and immersive environments where social situations can be simulated safely.
This study is designed to evaluate the effectiveness of VR exposure therapy compared with sertraline in adolescents and young adults diagnosed with SAD. Participants (N = 56) will be allocated to either VR therapy or sertraline treatment depending on treatment preference. The primary outcome will be reduction in social anxiety symptoms assessed with standardized clinical scales. Secondary outcomes will include functional improvements, treatment acceptability, and safety assessments.
The trial is conducted at Kocaeli University, Department of Child and Adolescent Psychiatry, and aims to provide evidence regarding whether VR exposure therapy can serve as an effective and acceptable alternative to pharmacological treatment in this population.
- Conditions
- Social Anxiety Disorder
- Being tested
- Virtual Reality Exposure Therapy, Sertraline (Oral Antidepressant)
- Keywords
- Social Phobia, Virtual Reality Exposure Therapy, Sertraline, Adolescents, Anxiety Disorders
- Medical subject headings
- Phobia, Social, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality Exposure TherapyBehavioural
Also called VR Therapy, VR Exposure
Participants receive structured Virtual Reality Exposure Therapy sessions using a VR headset. The intervention provides simulated social situations (e.g., public speaking, group interactions) to gradually expose participants to anxiety-provoking scenarios. The sessions are guided and standardized to target symptoms of social anxiety disorder.
Sertraline (Oral Antidepressant)Drug
Also called SSRI, Zoloft
Participants receive pharmacological treatment with Sertraline, a selective serotonin reuptake inhibitor (SSRI) commonly prescribed for social anxiety disorder. Dosage and administration will follow clinical guidelines and physician judgment.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Exposure Therapy | Experimental | RESEARCH ARM: This will be a group of volunteer patients who are being followed up with SAB in our outpatient clinic but who do not accept medication treatment and who will be informed about Virtual Reality Exposure Therapy (VRIT) through a poster presentation. Receives: Behavioral: Virtual Reality Exposure Therapy |
| Sertraline | Active comparator | CONTROL ARM: This will consist of patients who have newly applied to our outpatient clinic and have been diagnosed with Social Anxiety Disorder (SAD), who are the first treatment option in our routine outpatient clinic follow-up, who are deemed appropriate to begin sertraline treatment, and who accept medication treatment. Receives: Drug: Sertraline (Oral Antidepressant) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Social Anxiety Symptoms (Liebowitz Social Anxiety Scale, LSAS)
Change from baseline in social anxiety symptoms measured by the Liebowitz Social Anxiety Scale (LSAS). The LSAS evaluates fear and avoidance across 24 items covering social interaction and performance situations, providing total and subscale scores.
Measured: Baseline (Week 0), Week 6, and Week 12
Secondary outcomes (2)
Change in Social Phobia Symptoms (Çapa Social Phobia Scale for Children and Adolescents, ÇESFÖ)
Change from baseline in social phobia symptoms measured by the Çapa Social Phobia Scale for Children and Adolescents (ÇESFÖ), a 25-item self-report Likert-type scale developed for ages 9-17. Higher scores indicate greater severity of social phobia symptoms.
Measured: Baseline (Week 0), Week 6, and Week 12
Change in Anxiety Symptoms (Screen for Child Anxiety Related Emotional Disorders, SCARED)
Change from baseline in anxiety symptoms measured by the Screen for Child Anxiety Related Emotional Disorders (SCARED), including child- and parent-report forms (41 items total, yielding total and subscale scores).
Measured: Baseline (Week 0), Week 6, and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2025
- Study start15 Nov 2024
- Primary completionAug 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Social Anxiety DisorderStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- "Participants are assigned to one of two parallel groups: one group receives Virtual Reality Exposure Therapy, and the other group receives Sertraline treatment. The interventions are administered concurrently, without crossover between groups."
- Masking
- None (open label)
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emine Kanmaz
- Sponsor type
- University, hospital or other
- Collaborators
- Kocaeli University
- Responsible party
- Sponsor-investigator, Emine Kanmaz, Kocaeli University
- Investigators
- Nursu Çakın Memik, MD, Prof., Principal investigator, Kocaeli University, Department of Child and Adolescent PsychiatryEmine Kayış, MD, Study director, Kocaeli University, Department of Child and Adolescent Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07192367
- Sponsor's protocol ID
- SGMBT24
- Other IDs
- BAP-2024, KAEK/06.bI.08, 580850, 24-AKD-86
- Status last verified
- Sep 2025
- First submitted
- 17 Sep 2025
- Last updated
- 25 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared because this study is a single-center academic thesis project, and the data contains sensitive personal health information of minors. Data confidentiality and privacy regulations prevent sharing with external researchers.
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effectiveness Level of Virtual Reality Exposure Therapy With Sertraline Treatment in Social Anxiety Disorder
- ClinicalTrials.gov ID
- NCT07192367
- Acronym / sponsor ID
- SGMBT24
- Conditions
- Social Anxiety Disorder
- Keywords
- Social Phobia, Virtual Reality Exposure Therapy, Sertraline, Adolescents, Anxiety Disorders
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Emine KanmazUniversity, hospital or other
- Collaborators
- Kocaeli University
- Study start
- 15 Nov 2024 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 25 Sep 2025 (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.
This study compares two treatment approaches for adolescents and young adults with social anxiety. One group will participate in therapy sessions using a virtual reality headset, while the other group will receive sertraline, a commonly used medication for social anxiety. The goal is to see which treatment is more effective in reducing anxiety symptoms and improving daily functioning. The study will also look at how acceptable and safe these treatments are. A total of 56 participants will be enrolled at Kocaeli University, Department of Child and Adolescent Psychiatry.
Detailed description
Social anxiety disorder (SAD) is a common psychiatric condition that often begins in adolescence and causes significant impairment in academic, social, and occupational functioning. Although selective serotonin reuptake inhibitors (SSRIs) such as sertraline have demonstrated efficacy, many families and patients hesitate to use pharmacological treatments due to concerns about side effects and personal preferences. Virtual reality (VR)-based exposure therapy has emerged as a promising intervention by providing controlled and immersive environments where social situations can be simulated safely.
This study is designed to evaluate the effectiveness of VR exposure therapy compared with sertraline in adolescents and young adults diagnosed with SAD. Participants (N = 56) will be allocated to either VR therapy or sertraline treatment depending on treatment preference. The primary outcome will be reduction in social anxiety symptoms assessed with standardized clinical scales. Secondary outcomes will include functional improvements, treatment acceptability, and safety assessments.
The trial is conducted at Kocaeli University, Department of Child and Adolescent Psychiatry, and aims to provide evidence regarding whether VR exposure therapy can serve as an effective and acceptable alternative to pharmacological treatment in this population.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- "Participants are assigned to one of two parallel groups: one group receives Virtual Reality Exposure Therapy, and the other group receives Sertraline treatment. The interventions are administered concurrently, without crossover between groups."
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Exposure Therapy | Experimental | Behavioral: Virtual Reality Exposure TherapyRESEARCH ARM: This will be a group of volunteer patients who are being followed up with SAB in our outpatient clinic but who do not accept medication treatment and who will be informed about Virtual Reality Exposure Therapy (VRIT) through a poster presentation. |
| Sertraline | Active comparator | Drug: Sertraline (Oral Antidepressant)CONTROL ARM: This will consist of patients who have newly applied to our outpatient clinic and have been diagnosed with Social Anxiety Disorder (SAD), who are the first treatment option in our routine outpatient clinic follow-up, who are deemed appropriate to begin sertraline treatment, and who accept medication treatment. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (14 listed)
- RESEARCH ARM:
- 1 Applied to Kocaeli University Child and Adolescent Psychiatry Outpatient Clinic 2. Have normal intelligence based on clinical observation 3. Be between 12 and 17 years of age 4. Have a diagnosis of SAD 5. Have refused medication recommended for SAD 6. For SAD; are not currently receiving medical treatment 7. Have obtained written informed consent to participate in the study from them and/or their first-degree relatives authorized to make decisions about them 8. Have volunteered to participate in the study through an invitation poster presentation
- 1 Applied to Kocaeli University Child and Adolescent Psychiatry Outpatient Clinic 2. Have normal intelligence based on clinical observation 3. Be between 12 and 17 years of age 4. Have a diagnosis of SAD 5. For SAD; Not currently receiving medical treatment 6. Volunteer 7. Written consent for participation in the study must be obtained from the patient and/or their first-degree relative authorized to make decisions about them.
- 8. Accept sertraline treatment, routinely used in outpatient clinic follow-ups for SAD, and volunteer for the study.
Key exclusion criteria (14 listed)
- Substance use disorder
- Schizophrenia and bipolar disorder
- Autism spectrum disorder
- Cognitive disability
- Neurological disorder
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 |
|---|---|---|
| Virtual Reality Exposure TherapyAlso: VR Therapy, VR ExposureParticipants receive structured Virtual Reality Exposure Therapy sessions using a VR headset. The intervention provides simulated social situations (e.g., public speaking, group interactions) to gradually expose participants to anxiety-provoking scenarios. The sessions are guided and standardized to target symptoms of social anxiety disorder. | Behavioural | Virtual Reality Exposure Therapy |
| Sertraline (Oral Antidepressant)Also: SSRI, ZoloftParticipants receive pharmacological treatment with Sertraline, a selective serotonin reuptake inhibitor (SSRI) commonly prescribed for social anxiety disorder. Dosage and administration will follow clinical guidelines and physician judgment. | Drug | Sertraline |
Primary outcome
Change in Social Anxiety Symptoms (Liebowitz Social Anxiety Scale, LSAS)
Time frame: Baseline (Week 0), Week 6, and Week 12
Change from baseline in social anxiety symptoms measured by the Liebowitz Social Anxiety Scale (LSAS). The LSAS evaluates fear and avoidance across 24 items covering social interaction and performance situations, providing total and subscale scores.
2 secondary outcomes
Change in Social Phobia Symptoms (Çapa Social Phobia Scale for Children and Adolescents, ÇESFÖ)
Time frame: Baseline (Week 0), Week 6, and Week 12
Change in Anxiety Symptoms (Screen for Child Anxiety Related Emotional Disorders, SCARED)
Time frame: Baseline (Week 0), Week 6, and Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2025.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared because this study is a single-center academic thesis project, and the data contains sensitive personal health information of minors. Data confidentiality and privacy regulations prevent sharing with external researchers.
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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.
Nursu Çakın Memik, MD, Prof. principal investigator
Kocaeli University, Department of Child and Adolescent Psychiatry
Emine Kayış, MD study director
Kocaeli University, Department of Child and Adolescent Psychiatry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Virtual Reality Exposure Therapy and Sertraline (Oral Antidepressant) in people with Social Anxiety Disorder, run by Emine Kanmaz 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 14 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 25 Sep 2025. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emine Kayış, MD (+905557452890, eminekanmaz@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Social Anxiety Symptoms (Liebowitz Social Anxiety Scale, LSAS) (time frame: Baseline (Week 0), Week 6, and Week 12). 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 25 Sep 2025.