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临床试验/NCT05703711
NCT05703711招募中不适用

Combining mHealth and Nurse-delivered Care to Improve the Outcomes of People With Serious Mental Illness in West Africa

University of Washington2 个研究点 分布在 1 个国家目标入组 360 人开始时间: 2023年10月25日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
360
试验地点
2
主要终点
Psychiatric symptoms

研究概览

简要总结

In West Africa, most people with serious mental illness receive care from traditional or faith healers at prayer camps. The stepped-wedge cluster randomized trial aims to evaluate the effectiveness of a dual-pronged intervention package comprised of a mobile health program designed to train healers to deliver evidence-based psychosocial interventions combined with pharmacotherapy delivered directly to the patients at their prayer camps via a visiting nurse in Ghana.

详细描述

The study involves deployment of an intervention in Ghanian prayer camps where traditional and faith healers provide care for people with mental illness. The intervention has two components: a visiting nurse that provides medications to patients staying at the prayer camps combined with a smartphone app called M-Healer that is used by the staff working at the camps. The app is designed to provide them with training on how to deliver some psychosocial interventions, monitor the health and well-being of their patients, and protect human rights at the camps.

The stepped-wedge cluster randomized study design involves all participant groups beginning the trial receiving enhanced usual care with random sequential crossover of groups to the experimental condition until all groups have been exposed to the full intervention. Throughout the study, participant data will be collected at baseline, mid-treatment, and post-treatment. Following study completion, the intervention will be evaluated by comparing changes in psychiatric symptoms of participants from baseline to post-treatment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
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

  • Aged 18 years or older
  • Speaks Twi or English
  • Current inpatient staying at a study prayer camp
  • A diagnosis of psychosis, mania, or depression

排除标准

  • Serious physical illness or in need of urgent medical attention

结局指标

主要结局

Psychiatric symptoms

时间窗: Baseline, 4 weeks, 8 weeks

Change in psychiatric symptoms of study participants as measured by the Brief Psychiatric Rating Scale

Depressive symptoms

时间窗: Baseline, 4 weeks, 8 weeks

Change in depressive symptoms of participants as measured by the Patient Health Questionnaire-9

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

Dror Ben-Zeev

Professor: Psychiatry & Behavioral Sciences

University of Washington

研究点 (2)

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