Immersive Virtual Therapeutic Garden as a Support for Late-Life Depressive Symptoms: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- The Geriatric Depression Scale (GDS)(Change from baseline)
研究概览
简要总结
This study evaluates the addition of virtual therapy intervention in the treatment of depression in the elderly. Half of the participants will receive virtual reality treatment as an addition to physical exercises and psychoeducation, while the other half will receive physical exercises and psychoeducation alone.
详细描述
Depressive disorders are frequent and can either first be manifested at a younger age and recurrent during later life or have an onset beyond 60 years (late-life depression). The multifactorial genesis of depression in old age includes psychosocial, vascular and metabolic factors and requires multimodal and multi-professional therapy including physical activity and psychosocial interventions. However, there is still a percentage of older people who do not show improvement in depressive symptoms.
In recent years, various types of virtual reality are gaining in popularity, primarily because of the availability and ease of use. A systematic review from 2018 concluded that VR treatment had moderate to large effects in anxiety and depression, compared to controls and it could be another effective choice available to clinicians and patients.
Therefore, the aim of this project was to evaluate the effectiveness of virtual therapy in the elderly, in whom the previous multimodal therapeutic program has not brought the expected results.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •GDS≥10 or HADS-A≥8 or HADS-D≥8
排除标准
- •cognitive impairment (MMSE<24);
- •aphasia and a serious loss of sight or hearing that makes it impossible to assess cognitive functions based on MMSE;
- •contraindications for virtual therapy (epilepsy, vertigo, eyesight impairment);
- •substance abuse;
- •participation in another therapeutic project or individual psychotherapy;
- •antidepressant treatment;
结局指标
主要结局
The Geriatric Depression Scale (GDS)(Change from baseline)
时间窗: 15 minutes
The Geriatric Depression Scale is a self-report 30-items measure of well-being and mood in older adults. The patient responds in a "Yes/No" format. Scoring ranges from 0 to 30, where 11 and more means mood disorders. The higher score means the greater depression.
次要结局
- Hospital Anxiety and Depression Scale (HADS)(Change from baseline)(30 minutes)
研究者
Błażej Cieślik
Principal Investigator
Wroclaw University of Health and Sport Sciences