AniMovil mHealth Support for Depression Management in a Low-Income Country
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- Severity of depression symptoms, as measured by Patient Health Questionnaire, 9 item (PHQ9)
研究概览
简要总结
Depression is a huge public health problem in low and middle-income countries (LMICs). Mental health care systems in most LMICs are extremely limited, impeding the dissemination of WHO-recommended models for improving care via "task-shifting" services to community health workers (CHWs) who deliver evidence-based treatments such as cognitive behavioral therapy (CBT). This comprehensive intervention will use IVR and text messaging (SMS) to support effective depression care. Intervention patients will receive weekly automated (IVR) calls and daily text messages (SMS) throughout the 12 week intervention. Patients with more severe depression will receive up to 12 weekly CHW-delivered telephone CBT sessions, based on WHO recommendations and a treatment model developed and tested in India. CHWs will use patients' IVR contacts to enhance psychoeducation and they will use SMS plus web-based reports based on patients' IVR calls to identify individuals needing additional follow-up. The CHWs' clinical supervisor will use SMS messages to CHWs to reinforce best practices and monitor service delivery.
Patients will be enrolled from Colombian clinics associated with the Universidad de Los Andes in Bogota, Colombia. 114 patients will be randomized to either a usual enhanced care or intervention group. Intervention group patients will receive weekly automated (IVR) calls and daily text messages throughout the duration of the 12 week intervention. Patients with more severe depression will receive up to 12 weekly CHW-delivered telephone CBT sessions, based on WHO recommendations and a treatment model developed and tested in India. CHWs will use patients' IVR contacts to enhance psychoeducation and they will use SMS plus web-based reports based on patients' IVR calls to identify individuals needing additional follow-up. The CHWs' clinical supervisor will use SMS messages to CHWs to reinforce best practices and monitor service delivery. Program components will be modified to fit the local culture and clinical environment via iterative engagement of health professionals and patients with depression.
Those patients in usual enhanced care will receive the study manual and daily text messages and feedback throughout the duration of the program. Patients in the enhanced usual care group who present with more severe depression will be referred to the national program office for depression services support - a free service available to all citizens diagnosed with depression.
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
- None
入排标准
- 年龄范围
- 21 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A score of 10+ on the Spanish-validated version of the PHQ-9
排除标准
- •Less than a 6-month life expectancy
- •A history of psychiatric hospitalization or bipolar disorder
- •A substance use disorder or cognitive impairment
结局指标
主要结局
Severity of depression symptoms, as measured by Patient Health Questionnaire, 9 item (PHQ9)
时间窗: Change in PHQ scores at Baseline and 3 month follow-up
Depressive symptom severity. Min score=0, Max score=27. 0=not depressed, 27=severe depression.
次要结局
- Daily mood ratings(Changes in Daily mood scores between days 1-90)
- Health related quality of life as measured by Short Form Survey (SF12)(Change in SF12 score at Baseline and 3 month follow-up)
- Sheehan Disability Scale (SDS)(Change in score at Baseline and 3 month follow-up)
研究者
John Piette
VA Senior Research Career Scientist and Professor of Health Behavior Health Education, Public Health
University of Michigan