Effect of a Self-care Intervention on Depression in People With Age-related Macular Degeneration or Diabetic Retinopathy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change in depressive symptoms
研究概览
简要总结
The purpose of this trial is to determine the short-term effect of a self-care intervention on depression in patients with age-related macular degeneration or diabetic retinopathy.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinical diagnosis of wet or dry AMD or diabetic retinopathy
- •age 50 years and older
- •at least mild depressive symptoms (a score of 5 or more on the PHQ-9)
- •no legal blindness (visual acuity better than 20/200 in better eye).
排除标准
- •the current use of cognitive behavioural therapy
- •suicidal intent
- •ocular surgery during the study period (intravitreal anti-VEGF injections will be allowed, e.g. Lucentis)
- •cognitive impairment
- •inability to speak and understand French or English
- •profound hearing impairment.
研究组 & 干预措施
Self-Care Tools
The tool binder includes 3 core tools and 4 supplemental tools. The tools that will be provided include a variety of self-care approaches to manage depression including audio-visual, internet, and paper-based tools that might appeal to individuals with different learning styles. The 3 core tools consist of the Antidepressant Skills Workbook, a Mood Monitoring Tool, and a DVD on depression.
干预措施: Self-Care Tools (Behavioral)
Delayed Self-Care Tools
This group will receive the self-care tools at the conclusion of the study.
结局指标
主要结局
Change in depressive symptoms
时间窗: Baseline and 8 weeks
Depressive symptoms will be measured by the PHQ-9, a validated 9 item instrument.
次要结局
- Change in severity of anxiety symptoms(Baseline and 8 weeks)
- Change in self-efficacy(Baseline and 8 weeks)
- Change in life space(Baseline and 8 weeks)
研究者
Ellen Freeman
Associate Professor
Maisonneuve-Rosemont Hospital