Motivational Multicomponent Lifestyle Interventions as a Supportive Treatment for Depression in Primary Health Care
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- Change in Beck Depression Inventory (BDI) scores
研究概览
简要总结
The investigators aim to examine whether a motivational multicomponent lifestyle intervention as a supportive treatment for depression has a beneficial effect on recovery from depression in a primary health care setting.
详细描述
Depression causes a significant global burden of disease. Among depressed individuals, poor lifestyles, such as physical inactivity, unhealthy diet, and smoking, are common and play a role in the development and maintenance of depression. Robust research evidence recommends applying one-component lifestyle interventions that focus on factors such as a healthy diet or exercise, as a supportive treatment for depression. Currently, however, there is increasing interest in identifying the most effective multicomponent lifestyle intervention that targets more than one unhealthy lifestyle simultaneously in order to reduce depressive symptoms.
The study aims to examine whether a motivational multicomponent lifestyle intervention as a supportive treatment for depression has a beneficial effect on recovery from depression in a primary health care setting. The specific study questions are as follows:
- What is the effect of the intervention on depressive symptoms at 3- and 12-month follow-ups?
- What is the effect of the intervention on mental well-being at 3- and 12-month follow-ups?
- What kind of physical health do depressed patients in primary health care have? What kinds of effects does the intervention have on common physical health risk factors at 12- and 24- month follow-ups?
- What is the effect of the intervention on health-related quality of life?
- What is the cost-effectiveness of the intervention?
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adults ≥ 18 years
- •depression (ICD-10, F32-F33)
- •Beck Depression Inventory (BDI-1A) ≥ 10 points
- •the initiation of treatment in a primary health care center
排除标准
- •bipolar disorder
- •psychosis
- •substance abuse
- •pregnancy or lactation
- •a long-term rehabilitative psychotherapy.
结局指标
主要结局
Change in Beck Depression Inventory (BDI) scores
时间窗: Change from baseline at 3, 12 and 24 months
Depressive symptoms
Change in the Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) scores
时间窗: Change from baseline at 3, 12 and 24 months
Mental Wellbeing
Change in 15D scores
时间窗: Change from baseline at 3, 12 and 24 months
Health-Related Quality of Life
次要结局
- Change in Blood lipid levels(Change from baseline at 12 and 24 months)
- Change in waist circumference(Change from baseline at 3, 12 and 24 months)
- Change in Perceived Stress Scale (PSS-10) scores(Change from baseline at 3, 12 and 24 months)
- Change in weight/body mass index (BMI)(Change from baseline at 3, 12 and 24 months)
- Change in Blood pressure (diastolic and systolic)(Change from baseline at 3, 12, and 24 months)
- Change in Insomnia Severity Index (ISI) scores(Change from baseline at 3, 12 and 24 months)
- Change in Numeric Rating Scale for pain(Change from baseline at 3, 12 and 24 months)
- Change in Overall Anxiety Severity and Impairment Scale (OASIS) scores(Change from baseline at 3, 12 and 24 months)
- Change in Blood glucose levels(Change from baseline at 12 and 24 months)