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临床试验/NCT03720769
NCT03720769已完成不适用

Increasing Access to Mental Health Care for People Living in Lebanon: An E-Mental Health Intervention

VU University of Amsterdam1 个研究点 分布在 1 个国家目标入组 1,248 人开始时间: 2019年12月9日最近更新:
适应症

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

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

发起方
VU University of Amsterdam
申办方类型
Other
责任方
Principal Investigator
主要研究者

Pim Cuijpers

Professor

VU University of Amsterdam

研究点 (1)

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