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

NCT ID: NCT07250971

Last Updated: 2025-11-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-09
• Study Completion Date: 2025-09-15

Brief Summary

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.

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.

Conditions

Anxiety Disorders; Depressive Disorders

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Virtual Reality-Based Psychotherapeutic Program

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istanbul Aydın University

OTHER

Sponsor Role: lead

Responsible Party

Çağlar Charles Daniel Jaicks

Assist. Prof. Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Istanbul Aydın University, Department of Child and Adolescent Psychiatry

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

160/2025

Identifier Type: OTHER

Identifier Source: secondary_id

IAU-VR-160-2025

Identifier Type: -

Identifier Source: org_study_id