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Completed

NCT Number: NCT07250971

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

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.

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Key information

Age range

12 year–22 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Aydın University, Department of Child and Adolescent Psychiatry

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Virtual Reality-Based Psychotherapeutic Program

Behavioral

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.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Istanbul Aydın University

Other

Registry information

Official study title

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

Acronym: VR-PAD

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Nov 26, 2025
Registry last updated
Nov 26, 2025

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.

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