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绿色虚拟现实治疗抑郁症 (VR&depression)

2026年4月29日 更新者:Sykehuset Innlandet HF

虚拟自然体验作为中度抑郁症治疗的补充

抑郁症是一种常见的心理健康问题,可能导致情绪低落、精力不足、睡眠障碍以及日常功能困难。 许多轻中度抑郁症患者因服务获取受限、社会污名化或求助动机不足等障碍而未能获得充分治疗。 已有研究表明,体力活动和接触自然环境能改善心理健康,且在自然环境中进行的活动("绿色运动")相比室内运动可能带来额外的心理益处。 然而,抑郁症患者参与户外活动可能面临障碍,例如动机不足、自然环境接触机会有限或天气条件不利。

虚拟现实(VR)技术能够模拟沉浸式自然环境,可能提供一种在室内体验自然的方式。 VR介导的自然体验(或称"虚拟自然")能够提供与现实自然体验相似的心理益处。 此外,研究发现虚拟自然体验能增强自然联结感和进行绿色运动的意愿,进而可能促进实际绿色运动的参与。 尽管虚拟自然干预在不同健康背景下已显示出良好效果,并被认为安全可行,但将其整合至抑郁症临床标准治疗方案效果的研究仍十分有限。

本研究旨在探讨虚拟自然能否成为轻中度抑郁症患者标准治疗的有效补充。 具体而言,研究将评估标准治疗结合虚拟自然相比常规治疗是否能改善情绪并减轻抑郁症状。 研究还将探索干预措施是否会随时间推移影响参与者进行体力活动和户外绿色运动的动机。 最后,研究将比较两种向抑郁症治疗患者提供虚拟自然体验方式的可能差异:即"高端"实验室方案与"低端"自主管理方案。

参与者将从治疗抑郁和焦虑障碍的精神科门诊招募。 合格参与者应为确诊轻中度抑郁症的成年患者。 合并痴呆或精神疾病诊断,或其他严重躯体疾病的患者将被排除。 参与者将被随机分配至三组之一:(1)"高端"实验室VR干预结合标准治疗组,(2)"低端"自主管理VR干预结合标准治疗组,或(3)仅接受标准治疗的对照组。 干预将持续三周,评估时间点包括基线期、首次干预后、干预结束后及随访期。

研究将检测多项结果指标,包括急性效应和长期效应。 具体而言,为测试两种VR方案的急性效应,检测指标包括情感状态、自然联结感、绿色运动意愿及虚拟环境体验(如愉悦感、沉浸感和可能副作用如晕动症)。 为测试长期效应,检测指标包括情绪状态、抑郁焦虑症状变化以及体力活动与自然联结感的改变。

主要假设为:在常规治疗基础上接受虚拟自然的患者,其情绪和抑郁症状改善程度将优于仅接受标准治疗的患者。 次要假设为:接触虚拟自然可能随时间推移增强参与者在现实世界进行户外体力活动的动机和参与度。 最后,预计高端实验室VR干预将产生更积极的整体效果。

本研究将提供新知识,揭示虚拟自然体验是否能支持心理健康治疗,并帮助抑郁症患者增强体力活动水平和自然联结感。 若证明有效,该干预措施可为现有抑郁症治疗方法提供一种低成本、易获取的补充方案。

研究概览

研究类型

介入性

注册 (实际的)

45

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Hamar、挪威
        • Sykehus Innlandet

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

纳入标准:

  • 能够用挪威语进行口语交流和阅读
  • 被诊断为轻度至中度抑郁症

排除标准:

  • 同时患有痴呆症、精神疾病或其他严重躯体疾病

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:支持治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:双倍的

武器和干预

参与者组/臂
干预/治疗
有源比较器:对照组(常规治疗)
标准治疗与治疗师
标准治疗与治疗师
实验性的:基于工作室的
标准治疗与治疗师
由研究人员在工作室提供的高端VR体验,每周进行一次,包括通过连接到手动驱动跑步机的高端VR系统提供的模拟自然漫步。
实验性的:自我管理
标准治疗与治疗师
由参与者自我管理的低端VR体验。 在与研究人员进行介绍性会议后,参与者在干预期间收到一台独立的VR头显,其中包含预设的虚拟自然体验库。 鼓励参与者每日使用该头显。 使用VR头显的时间通过设备记录。

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Beck depression inventory II (BDI-II)
大体时间:Baseline; post-intervention (week 3); follow-up (week 12).

The BDI-II is a 21-item self-report questionnaire designed to measure the severity of depression.

The total score is calculated by summing the ratings (0-3) for all 21 items, with minimum score 0 (no or minimal depressive symptoms) and maximum score 63 (severe, high-level depressive symptoms).

A Norwegian translation of the scale commonly used in clinical settings is used in the study.

Baseline; post-intervention (week 3); follow-up (week 12).
Beck anxiety inventory (BAI)
大体时间:Baseline; post-intervention (week 3); follow-up (week 12).

The BAI is a 21-item self-report questionnaire used to measure the severity of anxiety in adults and adolescents.

Each item is rated from 0 ("not at all") to 3 ("a lot"). The total score is calculated by summing the ratings for all 21 items (minimum value 0 and maximum value 63), with higher scores indicating greater severity of anxiety.

A Norwegian translation of the scale commonly used in clinical settings is used in the study.

Baseline; post-intervention (week 3); follow-up (week 12).

次要结果测量

结果测量
措施说明
大体时间
Hopkins symptom checklist (HSCL-10)
大体时间:Baseline; post-intervention (week 3); follow-up (week 12).

The HSCL-10 is a 10-item self-report questionnaire designed to screen for symptoms of anxiety and depression, commonly used in both clinical and epidemiological studies to measure psychological distress. It includes 4 items related to anxiety and 6 items related to depression, focusing on symptoms experienced during the past week.

Each item is rated on a four-point scale (1 = "Not at all"; 2 = "A little"; 3 = "Quite a lot"; 4 = "Extremely"). The score is calculated by taking the mean of all item scores. The minimum Value is 1.0 (no psychological distress) while the maximum Value 4.0 (extreme psychological distress). A Cut-off Point is set at a mean score of 1.85 to identify individuals experiencing significant mental health distress.

A Norwegian translation of the scale commonly used in clinical settings is used in the study.

Baseline; post-intervention (week 3); follow-up (week 12).
Leisure time exercise questionnaire (LTEQ)
大体时间:Baseline; post-intervention (week 3); follow-up (week 12).

The LTEQ is a self-administered tool designed to assess the frequency and intensity of a person's leisure-time physical activity in a regular week (7 days). It measures how many times per week a person engages in strenuous, moderate, and mild/light physical activity for at least 15 minutes.

In this study, a modified version was also used to measure "active commuting", defined in a caption as "Walkin, running, biking to and from destinations such as work, the grocery, etc." The participant is required to report the number of times they engage in each level of intensity (strenuous, moderate, and mild/light) during a regular week. Examples are provided for each level of intensity. Higher scores indicate higher levels of activity.

The total score is calculated through the following formula: (n strenuous x 9) + (n moderate x 5) + (n mild/light x 3).

A Norwegian translation is used.

Baseline; post-intervention (week 3); follow-up (week 12).
Intention to perform green exercise (INT-GE)
大体时间:Baseline; immediately after the 1st VR exposure; post-intervention (week 3); follow-up (week 12).

The INT-GE is a questionnaire component designed to measure an individual's motivation, plans, and likelihood of engaging in physical activity within natural environments (e.g., parks, forests, coasts). It is often developed based on the Theory of Planned Behaviour (TPB) to predict future green exercise behaviour.

The scale contains five items, each rated on a 1-7 Likert scale, with the total score calculated as the mean of all items. The minimum score is 1.0 (no intention to perform green exercise), while the maximum is 5.0 (strong intention to perform green exercise).

A Norwegian translation of the scale is used.

Baseline; immediately after the 1st VR exposure; post-intervention (week 3); follow-up (week 12).
Connectedness with nature scale (CNS)
大体时间:Baseline; immediately after the 1st VR exposure; post-intervention (week 3); follow-up (week 12).

The state version of the CNS measures an individual's affective, experiential connection to the natural world at a given moment ("right now"). Based on the previous trait version of the scale, the state version is sensitive to acute changes. It contains 13 items, which are rated on a 1-7 Likert scale (1 = "Strongly disagree"; 7 = "Strongly agree"). The total score is calculated as the mean of all items, with lower scores (minimum value = 1.0) indicating a weaker sense of connectedness, while the higher scores (maximum value = 7.0) indicate a stronger sense of connectedness.

A Norwegian translation of the scale is used.

Baseline; immediately after the 1st VR exposure; post-intervention (week 3); follow-up (week 12).
Affect Scale (PAAS)
大体时间:Baseline; immediately after the 1st VR exposure; post-intervention (week 3); follow-up (week 12).

The PAAS is a 12-item self-report questionnaire designed to measure feeling states. It evaluates emotional responses across four distinct subscales (Positive affect, Negative affect, Tranquillity, and Fatigue) and is especially sensitive to acute changes associated with physical activity.

The PAAS consists of 12 items (three items per subscale), each describing a feeling (e.g., "Energetic", "Discouraged", "Relaxed", "Worn-out"). Participants rate their current feelings on a 5-point Likert scale, commonly ranging from 0 ("do not feel") to 4 ("feel very strongly"). Mean scores are calculated for each subscale, with a minimum possible score of 0 and a maximum of 4, with higher scores indicating higher levels for the subcategory.

A Norwegian translation is used.

Baseline; immediately after the 1st VR exposure; post-intervention (week 3); follow-up (week 12).

其他结果措施

结果测量
措施说明
大体时间
VR体验期间的享受感
大体时间:首次VR暴露后立即

这是一项由研究人员设计的单项问题,要求参与者对以下陈述的同意程度进行评分:“这次经历令人愉快”。

该问题采用0-10李克特量表进行评分,较低的值(最小值=0)表示没有愉悦感,而较高的值(最大值=10)表示更高水平的愉悦感。

使用了挪威语翻译。

首次VR暴露后立即
Sense of presence during the VR experience
大体时间:Immediately after the 1st VR exposure

The scale assesses the extent to which participants perceive themselves to be immersed or embedded within a virtual environment (i.e., presence). Each item relates to different aspects that can influence a person's sense of presence either positively (Being there, Realism, Sense of reality) or negatively (Awareness, Other persons, External noises, Flatness, Movement lag). The items are formulated as statements, each participant being asked to rate the extent to which they agreed with each of them on an 11-point Likert scale (0 = absolutely disagree, 10 = absolutely agree). Each item is scored and treated individually.

For Being there, Realism, and Sense of reality, higher scores indicate stronger sense of presence, hence greater effectiveness of the VR experience. For the other items, higher scores indicate a poorer sense of presence.

Immediately after the 1st VR exposure
Simulator sickness questionnaire (SSQ)
大体时间:Immediately after the 1st VR exposure

The SSQ measures symptoms similar to motion sickness but tailored to computer-based simulations. It asks participants to rate 16 symptoms (e.g., headache, eye strain, dizziness, nausea) on a four-point scale (0 = None; 1 = Slight; 2 = Moderate; 3 = Severe).

The 16 symptoms are grouped into three subscales (Nausea, Oculomotor, and Disorientation), which are weighted and summed to calculate a total score.

The minimum score is 0 (no symptoms, ideal outcome), and the maximum is 300 (extremely severe symptoms).

A Norwegian translation is used

Immediately after the 1st VR exposure
Perceived Environmental Restorativeness
大体时间:Immediately after the 1st VR exposure

The Perceived Environmental Restorativeness is a self-reported measure of an environment's potential to help individuals recover from mental fatigue, stress, and cognitive overload according to the Attention-Restoration Theory.

It contains 16 items, grouped in four subcategories: Fascination (5 items), Being Away (2 items), Extent/Coherence (4 items), and Compatibility (5 items).

Each item is rated on a 0-10 Likert scale. The score of each subcategory is calculated as the mean of the related items.

For Fascination, Being Away, and Compatibility, lower scores (minimum = 0.0) indicate smaller restorative potential, while higher scores (maximum = 10.0) indicate larger restorative potential. Unless the scores for Extent/Coherence are reversed, lower scores (minimum = 0.0) indicate larger restorative potential, while higher scores (maximum = 10.0) indicate smaller restorative potential.

A Norwegian translation of the scale is used.

Immediately after the 1st VR exposure

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2022年2月1日

初级完成 (实际的)

2025年4月1日

研究完成 (实际的)

2025年4月1日

研究注册日期

首次提交

2026年3月26日

首先提交符合 QC 标准的

2026年4月8日

首次发布 (实际的)

2026年4月15日

研究记录更新

最后更新发布 (实际的)

2026年5月5日

上次提交的符合 QC 标准的更新

2026年4月29日

最后验证

2026年3月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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