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临床试验/NCT07250971
NCT07250971已完成不适用

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

Istanbul Aydın University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年7月9日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
1
主要终点
Change in Depression Severity Measured by Hamilton Depression Rating Scale (HAM-D)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

盲法说明

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.

入排标准

年龄范围
12 Years 至 22 Years(Child, Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

  • •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.

研究组 & 干预措施

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.

干预措施: Virtual Reality-Based Psychotherapeutic Program (Behavioral)

结局指标

主要结局

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

时间窗: 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.

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

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
Istanbul Aydın University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Çağlar Charles Daniel Jaicks

Assist. Prof. Dr.

Istanbul Aydın University

研究点 (1)

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