NCT07192367

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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 56 (estimated)
• Sponsor: Emine Kanmaz · Academic / Other
• Sex: All
• Age: 12 Years – 17 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-11-15
• Primary completion: 2026-08-01
• Completion: 2026-12-01
• First posted: 2025-09-25
• Last updated: 2025-09-25

Locations

1 site across 1 country: Turkey (Türkiye)