Comparison of the Effectiveness Level of Virtual Reality Exposure Therapy With Sertraline Treatment in Social Anxiety Disorder

NCT ID: NCT07192367

Last Updated: 2025-09-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-15
• Study Completion Date: 2026-12-31

Brief 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. 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.

Conditions

Social Anxiety Disorder

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Virtual Reality Exposure Therapy

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.

Group Type: EXPERIMENTAL

Virtual Reality Exposure Therapy

Intervention Type: BEHAVIORAL

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

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.

Group Type: ACTIVE_COMPARATOR

Sertraline (Oral Antidepressant)

Intervention Type: DRUG

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.

Interventions

Virtual Reality Exposure Therapy

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.

Intervention Type: BEHAVIORAL

Sertraline (Oral Antidepressant)

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.

Intervention Type: DRUG

Other Intervention Names

VR Therapy; VR Exposure; SSRI; Zoloft

Eligibility Criteria

Inclusion Criteria

• 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 received written 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. 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.

Exclusion Criteria

RESEARCH ARM:

1. Substance use disorder

2. Schizophrenia and bipolar disorder

3. Autism spectrum disorder

4. Cognitive disability

5. Neurological disorder

6. Balance disorder

7. Patients who have received SSRI treatment for SAD in the last 6 months

CONTROL ARM:

1. Substance use disorder

2. Schizophrenia and bipolar disorder

3. Autism spectrum disorder

4. Cognitive disability

5. Patients who have received SSRI treatment for SAD within the last 6 months -

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kocaeli University

OTHER

Sponsor Role: collaborator

Emine Kanmaz

OTHER

Sponsor Role: lead

Responsible Party

Emine Kanmaz

Kocaeli University, Department of Child and Adolescent Psychiatry

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Nursu Çakın Memik, MD, Prof.

Role: PRINCIPAL_INVESTIGATOR

Kocaeli University, Department of Child and Adolescent Psychiatry

Emine Kayış, MD

Role: STUDY_DIRECTOR

Kocaeli University, Department of Child and Adolescent Psychiatry

Locations

Kocaeli University Hospital - Department of Child and Adolescent Psychiatry

Kocaeli, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Emine Kayış, MD

Role: CONTACT

eminekanmaz@gmail.com

+905557452890

Facility Contacts

Emine Kayış, MD (Assistant Doctor in Child

Role: primary

eminekanmaz@gmail.com

+905557452890

Nursu Çakın Memik, MD, Prof.

Role: backup

Other Identifiers

BAP-2024

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

KAEK/06.bI.08

Identifier Type: OTHER

Identifier Source: secondary_id

580850

Identifier Type: OTHER

Identifier Source: secondary_id

24-AKD-86

Identifier Type: OTHER

Identifier Source: secondary_id

SGMBT24

Identifier Type: -

Identifier Source: org_study_id