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RECRUITING

NCT07192367

PHASE4

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

Sponsor: Emine Kanmaz

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

12 Years - 17 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2024-11-15

Completion Date

2026-12

Last Updated

2025-09-25

Healthy Volunteers

Conditions

Social Anxiety Disorder

Interventions

BEHAVIORAL

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.

DRUG

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.

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 -

Locations (1)

Kocaeli University Hospital - Department of Child and Adolescent Psychiatry

Kocaeli, Turkey (Türkiye)