Increasing Access to Mental Health Care for People Living in Lebanon: An E-Mental Health Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,248
- 试验地点
- 1
- 主要终点
- Patient Health Questionnaire (PHQ-9)
研究概览
简要总结
The study objective is to test a guided e-mental health intervention called Step-by-Step for people living in Lebanon. Step-by-Step is a self-help programme delivered through an app or website and aims to treat symptoms of depression and other symptoms of psychological distress. First, a small study will be conducted to test the research procedure. Second, a large study will be conducted to test the effectiveness of Step-by-Step.
People residing in Lebanon (i.e. Lebanese, Palestinians and Syrian displaced people), above the age of 18 with symptoms of depression will be recruited through social media, posters, radio and television adverts, etc. Minors (under the age of 18) and people who have plans to end their life will be excluded from the study.
To test whether the use of Step-by-Step improves symptoms of depression, two groups will be compared. Participants in the intervention group will receive Step-by-Step, while those in the control group will receive basic information about depression and a list of health centres where they can get face-to-face help that is based on evidence. In addition, participants in the intervention group will receive weekly phone or chat support (up to 15 minutes) provided through lay helpers who were trained and work under the supervision of a trained clinical psychologist. The study hypothesises that participants who receive Step-by-Step will have a higher symptom improvement than participants who receive basic information.
In order to assess symptoms of depression and other symptoms of psychological distress, participants in this study will complete several questionnaires three times: At the beginning of the study, after 8 weeks, and then three months later (i.e. 5 months after the beginning of the study).
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
- •Age 18 or above
- •PHQ-9 sum score above 9
- •WHODAS 2.0 sum score above 16
排除标准
- •Serious thoughts or plans to end one's life
结局指标
主要结局
Patient Health Questionnaire (PHQ-9)
时间窗: 8 weeks
Self-administered instrument for depression screening (intention-to-treat analysis)
WHO Disability Assessment Schedule 2.0 (WHODAS 2.0)
时间窗: 8 weeks
Generic assessment instrument for health and disability (intention-to-treat analysis)
次要结局
- (Adapted) Client Service Receipt Inventory (CSRI)(8 weeks)
- Generalized Anxiety Disorder - 7 Questionnaire (GAD-7)(8 weeks)
- PTSD Checklist for DSM-5 (PCL-6)(8 weeks)
- WHO-5 Well-Being Index(8 weeks)
- Self-defined psychosocial problems (PSYCHLOPS)(8 weeks)
研究者
Pim Cuijpers
Professor
VU University of Amsterdam
