Comparison of the Effectiveness Level of Virtual Reality Exposure Therapy With Sertraline Treatment in Social Anxiety Disorder
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Change in Social Anxiety Symptoms (Liebowitz Social Anxiety Scale, LSAS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
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.
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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 obtained written informed 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
- •Have normal intelligence based on clinical observation
- •Be between 12 and 17 years of age
- •Have a diagnosis of SAD
- •For SAD; Not currently receiving medical treatment
- •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.
排除标准
- •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 -
研究组 & 干预措施
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.
干预措施: Virtual Reality Exposure Therapy (Behavioral)
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.
干预措施: Sertraline (Oral Antidepressant) (Drug)
结局指标
主要结局
Change in Social Anxiety Symptoms (Liebowitz Social Anxiety Scale, LSAS)
时间窗: 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.
次要结局
- Change in Anxiety Symptoms (Screen for Child Anxiety Related Emotional Disorders, SCARED)(Baseline (Week 0), Week 6, and Week 12)
- Change in Social Phobia Symptoms (Çapa Social Phobia Scale for Children and Adolescents, ÇESFÖ)(Baseline (Week 0), Week 6, and Week 12)
研究者
Emine Kanmaz
Kocaeli University, Department of Child and Adolescent Psychiatry
Kocaeli University