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

NCT07250971 | Completed

• 2 other identifiers: IAU-VR-160-2025160/2025
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety Disorders; Depressive Disorders

Keywords

Virtual Reality; Psychotherapy; Psychoeducation; Non-Pharmacological Treatment; Mental Health; Adolescents; Depression; Anxiety; Digital Therapeutics; Immersive Therapy

Outcome Measures

Primary Outcomes (1)

• Change in Depression Severity Measured by Hamilton Depression Rating Scale (HAM-D)

  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)

Study Arms (1)

Virtual Reality-Based Psychotherapeutic and Psychoeducational Intervention

EXPERIMENTAL

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

Interventions

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.

Virtual Reality-Based Psychotherapeutic and Psychoeducational Intervention

Eligibility Criteria

• Age: 12 Years - 22 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istanbul Aydın University: lead

Study Sites (1)

Istanbul Aydın University, Department of Child and Adolescent Psychiatry

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders; Depressive Disorder; Psychological Well-Being; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Mood Disorders; Personal Satisfaction; Behavior; Behavioral Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: This study was conducted as an open-label design. Neither participants nor investigators were blinded to the intervention. All participants received the same virtual reality (VR)-based psychotherapeutic and psychoeducational sessions, and both the participants and supervising clinicians were fully aware of the intervention content and duration. No masking procedures were implemented, as the behavioral nature of the study required active participant engagement with the VR program.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist. Prof. Dr.

Model Details: All participants received the same virtual reality (VR)-based psychotherapeutic and psychoeducational intervention consisting of five weekly sessions. Each session included relaxation, exposure, coping skills, and psychoeducation modules delivered through Meta Quest 2 headsets under professional supervision. There were no control or comparison groups. A pre-test-post-test design was used to measure changes in anxiety and depression symptoms before and after the VR intervention.

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 26, 2025
• Study Start: July 9, 2025
• Primary Completion: August 15, 2025
• Study Completion: September 15, 2025
• Last Updated: November 26, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)