Virtual Reality-Based Psychotherapeutic and Psychoeducational Intervention for Anxiety and Depression in Children, Adolescents, and Adults (VR-PAD)

November 25, 2025 updated by: Çağlar Charles Daniel Jaicks, Istanbul Aydın University

Efficacy of Virtual Reality-Based Psychotherapeutic and Psychoeducational Interventions on Anxiety and Depression Symptoms

This study is designed as a non-pharmacological, interventional clinical research project to evaluate the feasibility, safety, and implementation of virtual reality (VR)-based psychoeducational and psychotherapeutic interventions for individuals with anxiety and/or depression. Participants include children, adolescents, and adults who meet DSM-5 diagnostic criteria or present with subthreshold symptoms associated with functional impairment and who decline pharmacological treatment.

A total of 40 participants are planned to receive five weekly individual VR sessions conducted under the supervision of a psychiatrist or clinical psychologist. The VR intervention will be administered using Meta Quest 2 headsets and will include modules focused on relaxation and breathing exercises, exposure-based tasks, coping strategies for anxiety and procrastination, study skills (e.g., Pomodoro technique), sleep hygiene, and psychoeducation about healthy behaviors. Each session will last approximately 20-40 minutes and will be conducted in a controlled clinical environment to ensure participant safety.

Anxiety and depression levels will be assessed before and after the intervention using validated clinical scales, including the Hamilton Depression Rating Scale and the Beck Depression Inventory. Side effects such as dizziness, nausea, and disorientation will be monitored throughout the study. The primary objective is to evaluate feasibility, implementation, and acceptability of VR-based interventions in a clinical mental health setting. Secondary objectives include exploring pre-post changes in anxiety and depression scores and documenting safety and tolerability of the VR intervention.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study is designed as a non-pharmacological, interventional clinical research project to evaluate the feasibility, safety, and implementation of virtual reality (VR)-based psychoeducational and psychotherapeutic interventions for individuals with anxiety and/or depression. Participants include children, adolescents, and adults who meet DSM-5 diagnostic criteria or present with subthreshold symptoms associated with functional impairment and who decline pharmacological treatment.

A total of 40 participants are planned to receive five weekly individual VR sessions conducted under the supervision of a psychiatrist or clinical psychologist. The VR intervention will be administered using Meta Quest 2 headsets and will include modules focused on relaxation and breathing exercises, exposure-based tasks, coping strategies for anxiety and procrastination, study skills (e.g., Pomodoro technique), sleep hygiene, and psychoeducation about healthy behaviors. Each session will last approximately 20-40 minutes and will be conducted in a controlled clinical environment to ensure participant safety.

Anxiety and depression levels will be assessed before and after the intervention using validated clinical scales, including the Hamilton Depression Rating Scale and the Beck Depression Inventory. Side effects such as dizziness, nausea, and disorientation will be monitored throughout the study. The primary objective is to evaluate feasibility, implementation, and acceptability of VR-based interventions in a clinical mental health setting. Secondary objectives include exploring pre-post changes in anxiety and depression scores and documenting safety and tolerability of the VR intervention.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
      • Istanbul, Turkey (Türkiye)
        • Istanbul Aydın University, Department of Child and Adolescent Psychiatry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosis of anxiety and/or depression according to DSM-5 criteria, or presence of subthreshold symptoms associated with functional impairment.
  • Age between 12 and 25 years.
  • No psychopharmacological treatment within the past 12 months.
  • Voluntary participation and written informed consent for the virtual reality sessions.
  • Sufficient cognitive capacity to understand and engage with VR-based interventions.
  • Referred by a qualified mental health professional for non-pharmacological therapy.

Exclusion Criteria:

  • History of epilepsy, hypertension, or neurological/cardiovascular conditions that contraindicate the use of virtual reality.
  • Presence of psychotic disorder or severe cognitive impairment.
  • Stent placement in cerebral or cardiac vessels.
  • Current or past-year use of psychiatric medication.
  • Refusal or inability to tolerate virtual reality exposure.
  • Any medical or psychiatric condition that prevents safe participation in VR sessions.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Virtual Reality-Based Psychotherapeutic and Psychoeducational Intervention
All participants received a virtual reality (VR)-based psychotherapeutic and psychoeducational program consisting of five weekly individual sessions lasting 20-40 minutes each. The intervention included modules on relaxation and breathing exercises, exposure, coping strategies, study skills, and sleep hygiene. Sessions were delivered using Meta Quest 2 headsets under professional supervision.
Behavioral: Virtual Reality-Based Psychotherapeutic Program
A behavioral intervention delivered through virtual reality (VR) technology designed to reduce symptoms of anxiety and depression. The program included immersive psychoeducational and psychotherapeutic content focusing on relaxation, exposure, coping skills, and healthy routines. Each participant completed five supervised weekly sessions using Meta Quest 2 headsets.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Depression Severity Measured by Hamilton Depression Rating Scale (HAM-D)
Time Frame: Baseline and Week 5 (end of intervention)
Depression severity will be measured using the Hamilton Depression Rating Scale (HAM-D) before and after completion of the five-session VR intervention. The total score ranges from 0 to 52, with higher scores indicating greater depressive symptom severity. A decrease in total score represents clinical improvement.
Baseline and Week 5 (end of intervention)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul Aydın University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 9, 2025

Primary Completion (Actual)

August 15, 2025

Study Completion (Actual)

September 15, 2025

Study Registration Dates

First Submitted

November 17, 2025

First Submitted That Met QC Criteria

November 25, 2025

First Posted (Actual)

November 26, 2025

Study Record Updates

Last Update Posted (Actual)

November 26, 2025

Last Update Submitted That Met QC Criteria

November 25, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IAU-VR-160-2025
  • 160/2025 (Other Identifier: Non-Interventional Clinical Research Ethics Committee of Istanbul Aydın University)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) will not be shared due to privacy and ethical considerations involving sensitive mental health information.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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