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临床试验/NCT06125899
NCT06125899尚未招募不适用

Intervention for Depression in Underserved Geriatric Populations

University of Ibadan0 个研究点目标入组 110 人开始时间: 2024年2月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
110
主要终点
Depression remission

研究概览

简要总结

The aim of this hybrid (Effectiveness-Implementation) cluster randomised controlled clinical trial is to test the feasibility of implementing an age-appropriate electronic version of the WHO Mental Health Gap Action Programme Intervention Guide (emhGAP-Age) in routine home-based care of older Nigerians with depression. The main questions it aims to answer are:

  1. Whether the emhGAP-Age demonstrate sufficient signals of effectiveness in the identification and home management of late life depression to permit for further exploration in a fully powered clinical trial?
  2. What are the logistical, programmatic, and operational requirements for a home-delivered emhGAP-Age in a sample of older people with depression in Nigeria? Consenting older participants with depression in the intervention arm will receive treatment based on emhGAP-Age which consists of;
  • Adapted electronic generic version of the WHO Mental Health Gap Action Programme Intervention Guide (emhGAP-IG)
  • Adapted Problem-Solving Therapy (PST-PC)
  • Support/supervision of providers
  • Links to social support resources. Researchers will compare with treatment based on the basic specification in the generic emhGAP-IG (consisting of basic psychoeducation and stress reduction) for effects on depression remission.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 60 years,
  • PHQ-9 score of ≥11 during routine consultation

排除标准

  • Severe co-morbidity requiring urgent attention.
  • Severe cognitive impairment/dementia (Community Screening Instruments for Dementia score≤ 20) .
  • Active suicidal intention.
  • Evidence of bipolar/psychosis/severe substance use disorders.
  • Planning to move out of the study catchment area within 6 months.
  • Refusing/lacking capacity to consent/accent

结局指标

主要结局

Depression remission

时间窗: At six months post trial entry

Patient Health Questionnaire (PHQ-9) score \< 6

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Akin Ojagbemi

Senior Lecturer

University of Ibadan

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