VR exposure therapy versus sertraline for social anxiety in teens

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

This study will test whether virtual reality exposure therapy or the medication sertraline works better for adolescents aged 12–17 with social anxiety.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 56 (estimated)
• Ages: 12 Years to 17 Years
• Sex: All
• Sponsor: Kocaeli University (other)
• Locations: 1 site (Kocaeli)
• Trial ID: NCT07192367 on ClinicalTrials.gov

What this trial studies

This single-site, preference-allocated study at Kocaeli University will enroll 56 adolescents and young people with diagnosed social anxiety disorder and compare two treatment approaches: therapist-led virtual reality exposure sessions using a headset, and oral sertraline medication. Participants choose the treatment they prefer and then receive that intervention according to standardized protocols over the study period. The primary outcome is reduction in social anxiety symptoms using validated clinical scales, with secondary outcomes including daily functioning, treatment acceptability, and safety measures. The goal is to determine whether VR exposure can be an effective and acceptable alternative to pharmacological treatment in this age group.

Who should consider this trial

Good fit: Ideal candidates are 12–17-year-olds diagnosed with social anxiety disorder, not currently on psychiatric medication, with normal intelligence and who can provide informed consent with guardian approval.

Not a fit: Patients with severe comorbid psychiatric or medical conditions, intolerance to SSRIs, or those who cannot tolerate VR (for example due to motion sickness or epilepsy) may not benefit from the interventions tested here.

Why it matters

Potential benefit: If successful, the study could show that VR exposure offers an effective non-drug option that reduces social anxiety and may be more acceptable to some adolescents and families.

How similar studies have performed: Prior research shows sertraline and other SSRIs are established treatments for social anxiety and VR exposure therapy has shown promising results in adults and adolescents, though VR is less extensively studied in youth than medication.

Eligibility criteria

Inclusion Criteria:

* RESEARCH 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 received written 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. 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.

8\. Accept sertraline treatment, routinely used in outpatient clinic follow-ups for SAD, and volunteer for the study.

Exclusion Criteria:

RESEARCH ARM:

1. Substance use disorder
2. Schizophrenia and bipolar disorder
3. Autism spectrum disorder
4. Cognitive disability
5. Neurological disorder
6. Balance disorder
7. Patients who have received SSRI treatment for SAD in the last 6 months

CONTROL ARM:

1. Substance use disorder
2. Schizophrenia and bipolar disorder
3. Autism spectrum disorder
4. Cognitive disability
5. Patients who have received SSRI treatment for SAD within the last 6 months -

Where this trial is running

Kocaeli

• Kocaeli University Hospital - Department of Child and Adolescent Psychiatry — Kocaeli, Turkey (Türkiye) (RECRUITING)

Study contacts

• Principal investigator: Nursu Çakın Memik, MD, Prof. — Kocaeli University, Department of Child and Adolescent Psychiatry
• Study coordinator: Emine Kayış, MD

Conditions: Social Anxiety Disorder, Social Phobia, Virtual Reality Exposure Therapy, Sertraline, Adolescents, Anxiety Disorders