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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age12-17
SponsorEmine Kanmaz

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Substance use disorder

Schizophrenia and bipolar disorder

Autism spectrum disorder

Cognitive disability

Trial design

Design model

Parallel

Treatments tested in this trial

  • Virtual Reality Exposure Therapy

    Behavioral

    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.

  • Sertraline (Oral Antidepressant)

    Drug

    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.

Treatment groups

56 Participants
are divided into 2 treatment groups
Group A: Virtual Reality Exposure TherapyExperimental treatment 1 intervention
Group B: SertralineActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in Social Anxiety Symptoms (Liebowitz Social Anxiety Scale, LSAS)

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

Secondary outcomes

1

Change in Social Phobia Symptoms (Çapa Social Phobia Scale for Children and Adolescents, ÇESFÖ)

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
2

Change in Anxiety Symptoms (Screen for Child Anxiety Related Emotional Disorders, SCARED)

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).

Time frame
Baseline (Week 0), Week 6, and Week 12

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Emine Kanmaz

Lead sponsor

Kocaeli University

Sponsor institution

Kocaeli University

Collaborator