Pilot Trial of an Evidence-based Community Intervention to Improve Depressive Symptoms Among Peruvian Older Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Depressive symptoms
研究概览
简要总结
The goal of this pilot trial is to test how feasible is to conduct a large clinical trial that evaluate both implementation and effectiveness outcomes of a community-based interventions for older adults with depression in low-resource urban settings from Lima, Peru.
The main questions:
Is the way we are planning the study, including those who are taking part and what they will do, good for a large study?
Is the interventional package we are developing good the way it is, and can it be done the way we planned it?
详细描述
Participants who join will be split into two groups: one group will get the interventional program, and the other group will get standard care. In the interventional group, community health workers will meet with participants eight times to do activities and talk about how they feel. The standard group will have two visits where they will learn things about mental health.
The results of the study will help the researchers understand whether they can test the program in larger study. Additionally, see whether those participants in the interventional group feel better than those who are in the standard group.
Sample size: This is a pilot trial. No sample size calculations are needed because the objective is NOT to evaluate the effect of the intervention, but rather the feasibility of conducting a large-scale clinical trial. It is expected to enroll 64 participants (32 control group vs 32 intervention group). This number is based on previous formative study and training of community health workers.
Researchers will collect basic information to assess feasibility for a larger trial, including:
- Number of potential participants screened per month;
- Number of participants enroled per month;
- Average time from enrolment to randomisation.
- Average time to reach enrolment goal
- Proportion of eligible participants who enrol
- Proportion of people who maintain the study in both groups.
- Reasons for abandoning the study.
- Visit durations
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
We will try to mask the outcome assessor, but for the nature of the intervention, it will be difficult that outcome assessor remain blind.
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Having depressive symptoms (score equal to or greater than 6 on the Patient Health Questionnaire - PHQ 9).
- •Capacity to give consent.
- •Current residence in Villa El Salvador, Lima, Peru.
排除标准
- •Previous diagnosis of bipolar disorder
- •History of substance abuse
- •History of dissociative disorder, psychosis or dementia, or moderate memory and/or cognition problems.
研究组 & 干预措施
Intervention group
VIDACTIVA program
干预措施: VIDACTIVA sessions (Behavioral)
Control group
Standard Care
干预措施: Standard Care (Behavioral)
结局指标
主要结局
Depressive symptoms
时间窗: At baseline, at 14th and 22th week.
Measured by Patient Health Questionnaire - 9 (PHQ-9) \[ minimum score: 0 ; maximum score: 27 \] \[More score = worse symptoms\]
Depressive Symptoms
时间窗: From enrollment to the end of treatment at 14th week , 22th week
Measured by Patient Health Questionnaire - 9 (PHQ-9) \[ minimum score: 0 ; maximum score: 27 \] \[More score = worse symptoms\]
次要结局
- Loneliness(At baseline, at 14th and 22th week.)
- Anxiety symptoms(At baseline, at 14th and 22th week.)
- Anxiety Symptoms(From enrollment to the end of treatment at 14th week, and 22week)
- Loneliness(From enrollment to the end of treatment at 14th week, and 22 week)