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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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.
• Препарат 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.

Первичные конечные точки

• Change in Social Anxiety Symptoms (Liebowitz Social Anxiety Scale, LSAS) [Срок оценки: Baseline (Week 0), Week 6, and Week 12]

Вторичные конечные точки (2)

• Change in Social Phobia Symptoms (Çapa Social Phobia Scale for Children and Adolescents, ÇESFÖ) [Срок оценки: Baseline (Week 0), Week 6, and Week 12]
• Change in Anxiety Symptoms (Screen for Child Anxiety Related Emotional Disorders, SCARED) [Срок оценки: Baseline (Week 0), Week 6, and Week 12]

Критерии участия

Критерии включения

• 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:

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.

Критерии исключения

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 -

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Turkey (Türkiye) · 1 центр

• Kocaeli University Hospital - Department of Child and Adolescent Psychiatry — Kocaeli

Идентификаторы

NCT: NCT07192367 · SGMBT24 · BAP-2024 · KAEK/06.bI.08 · 580850 · 24-AKD-86

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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