Kocaeli University Hospital - Department of Child and Adolescent Psychiatry
Kocaeli, 41000, Turkey (Türkiye)
Location status: Recruiting
NCT Number: NCT07192367
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.
Interested in participating?
Request Info12 year–17 year
All sexes
Interventional
Phase 4
Kocaeli, 41000, Turkey (Türkiye)
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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.
Exclusion criteria
RESEARCH ARM:
CONTROL ARM:
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.
Other names: VR Therapy, VR Exposure
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.
Other names: SSRI, Zoloft
Time frame: 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.
Time frame: Baseline (Week 0), Week 6, and Week 12
Change from baseline in social phobia symptoms measured by the Çapa Social Phobia Scale for Children and Adolescents (ÇESFÖ), a 25-item self-report Likert-type scale developed for ages 9-17. Higher scores indicate greater severity of social phobia symptoms.
Time frame: Baseline (Week 0), Week 6, and Week 12
Change from baseline in anxiety symptoms measured by the Screen for Child Anxiety Related Emotional Disorders (SCARED), including child- and parent-report forms (41 items total, yielding total and subscale scores).
Interested in participating?
Request InfoEmine Kanmaz
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07774481
Anxiety, Anxiety Acute
Columbus, Ohio, United States
View Trial DetailsNCT06934525
Agoraphobia, Anxiety
East Providence, Rhode Island, United States
View Trial DetailsNCT06563310
Anxiety, Anxiety Disorders
Ann Arbor, Michigan, United States
View Trial DetailsNCT04793828
Anxiety Disorders, Generalized Anxiety Disorder
Berlin, Germany
View Trial Details