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临床试验/NCT06093646
NCT06093646招募中不适用

Proposal to Address the Medium- to Long-term EBOLA Associated Psychological Distress and Psychosocial Problems in Mubende District in Central Uganda (Ebola+D Project)

MRC/UVRI and LSHTM Uganda Research Unit1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2023年9月22日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
1,000
试验地点
1
主要终点
Addressing the medium- to long-term EBOLA associated psychological Distress and psychosocial problems in Mubende District in central Uganda

研究概览

简要总结

Screen participants attending 11 healthcare facilities in Mubende District for psychological distress using the locally validated Luganda or English version of the WHO- Self Report Questionnaire (SRQ-20). Those individuals found to have significant psychological distress (a score of 6 and above) will be offered Ebola+D intervention [a stepped care collaborative delivery model to address the medium- to long-term EBOLA associated psychological Distress and psychosocial problems] . A cohort of Ebola Virus Disease (EVD) affected individuals accessing the Ebola +D mental health intervention will be recruited and followed up for 12 months with assessments at three time points; baseline, 3 months and 12 months.

详细描述

Ebola Virus Disease (EVD) is associated with high mortality, physical morbidity among patients and survivors, plus being associated with significant mental health and psychosocial problems among patients/survivors, their family members, members of the affected communities, health workers and volunteers. To support the medical services of Mubende district cope with the Ebola associated mental health and psychosocial problems, the Ministry of Health of Uganda has partnered with the MRC/UVRI & LSHTM Uganda Research Unit to implement a health systems strengthening project in the district entitled, 'Addressing the medium to long-term EBOLA associated psychological Distress and psychosocial problems in Mubende District in central Uganda (Ebola+D Project)'.

Methodology: The project will be undertaken in the 11 selected health care facilities in Mubende district. Members of the community attending these selected health care facilities will be screened for psychological distress using the locally validated Luganda or English version of the WHO- Self Report Questionnaire (SRQ-20). Those individuals found to have significant psychological distress (a score of 6 and above) will be offered Ebola+D intervention. A cohort of EVD affected individuals accessing the Ebola +D mental health intervention will be recruited and followed up for 12 months with assessments at three time points; baseline, 3 months and 12 months.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

盲法说明

Masking will not be applied; eligible participants (with psychological distress) who consent to participate in this study will be offered the Ebola+D intervention

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

  • Community member of Mubende district staying within the catchment area of the primary health care facility (PHCF);
  • 18years and above,
  • Able to communicate in either English or Luganda (local language spoken in the study region and the language into which the questionnaires will be translated),
  • Has a WHO SRQ-20 score of 6 and above (except for Ebola survivors who are eligible even when their SRQ-20 score is either below or above 6). -

排除标准

  • Unable to engage with the research process for any reason that may include sensory impairment or cognitive impairment

结局指标

主要结局

Addressing the medium- to long-term EBOLA associated psychological Distress and psychosocial problems in Mubende District in central Uganda

时间窗: Reduced psychological distress (SRQ-20 scores < 6) on two occasions ''4 weeks'' apart.

Remission at ''3 months'' after completion of prescribed mental health treatment step(s) reduced psychological distress (SRQ-20 scores \< 6) on two occasions ''4 weeks'' apart

次要结局

未报告次要终点

研究者

发起方
MRC/UVRI and LSHTM Uganda Research Unit
申办方类型
Other
责任方
Sponsor

研究点 (1)

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