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

NCT07192367 | Recruiting Phase 4

• 5 other identifiers: SGMBT24BAP-2024KAEK/06.bI.0858085024-AKD-86
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Social Anxiety Disorder

Keywords

Social Phobia; Virtual Reality Exposure Therapy; Sertraline; Adolescents; Anxiety Disorders

Outcome Measures

Primary Outcomes (1)

• 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.

  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)

  Baseline (Week 0), Week 6, and Week 12

• Change in Anxiety Symptoms (Screen for Child Anxiety Related Emotional Disorders, SCARED)

  Baseline (Week 0), Week 6, and Week 12

Study Arms (2)

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.

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.

Drug: Sertraline (Oral Antidepressant)

Interventions

Virtual Reality Exposure Therapy 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.

Also known as: VR Therapy, VR Exposure

Virtual Reality Exposure Therapy

Sertraline (Oral Antidepressant) 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.

Also known as: SSRI, Zoloft

Sertraline

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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
• 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:
• 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:
• 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.
• \. Accept sertraline treatment, routinely used in outpatient clinic follow-ups for SAD, and volunteer for the study.

You may not qualify if:

• RESEARCH ARM:
• Substance use disorder
• Schizophrenia and bipolar disorder
• Autism spectrum disorder
• Cognitive disability
• Neurological disorder
• 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 -

Sponsors & Collaborators

• Emine Kanmaz: lead
• Kocaeli University: collaborator

Study Sites (1)

Kocaeli University Hospital - Department of Child and Adolescent Psychiatry

Kocaeli, 41000, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Phobia, Social; Anxiety Disorders

Interventions

Virtual Reality Exposure Therapy; Sertraline; Antidepressive Agents

Condition Hierarchy (Ancestors)

Phobic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Desensitization, Psychologic; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; 1-Naphthylamine; Amines; Organic Chemicals; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Psychotropic Drugs; Central Nervous System Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Nursu Çakın Memik, MD, Prof.

  Kocaeli University, Department of Child and Adolescent Psychiatry

  PRINCIPAL INVESTIGATOR

• Emine Kayış, MD

  Kocaeli University, Department of Child and Adolescent Psychiatry

  STUDY DIRECTOR

Central Study Contacts

Emine Kayış, MD

CONTACT

+905557452890; eminekanmaz@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label study. Neither participants, care providers, investigators, nor outcome assessors are blinded to the intervention assignments. The nature of the interventions (VR exposure therapy vs. sertraline treatment) makes blinding infeasible.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Kocaeli University, Department of Child and Adolescent Psychiatry

Model Details: "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."

Study Record Dates

• First Submitted: September 17, 2025
• First Posted: September 25, 2025
• Study Start: November 15, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 25, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)