Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2025-12-25 @ 10:39 PM
Study NCT ID:
NCT07192367
Status:
RECRUITING
Last Update Posted:
2025-09-25
First Post:
2025-09-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of the Effectiveness Level of Virtual Reality Exposure Therapy With Sertraline Treatment in Social Anxiety Disorder
Sponsor:
Emine Kanmaz
Organization:
Study Overview
Official Title:
Comparison of the Effectiveness Level of Virtual Reality Exposure Therapy With Sertraline Treatment in Social Anxiety Disorder
Status:
RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| BAP-2024 | OTHER_GRANT | Kocaeli University Scientific Research Projects Coordination Unit (BAP) | View | |
| KAEK/06.bI.08 | OTHER | Kocaeli University Clinical Research Ethics Committee | View | |
| 580850 | OTHER | Kocaeli University Rectorate (Document No: E-89460677-730.99-580850) | View | |
| 24-AKD-86 | OTHER | Turkish Medicines and Medical Devices Agency (TITCK) | View |