Programa Esperanza (Project Hope): A Depression Program for Older Latinos With Chronic Medical Conditions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 259
- 主要终点
- PHQ-9
研究概览
简要总结
The purpose of this study is to determine whether individually-administered Problem Solving Treatment is effective in managing depressive symptomatology in 250 primarily Spanish-speaking Latino patients ≥55 years of age or older with high medical comorbidity. The aim is to test if Programa Esperanza improves: a) problem solving skills and behavior activation; b) depression-related outcomes; and b) physical functioning compared to enhanced usual care over the course of one year.
详细描述
The primary aim is to test the comparative effectiveness of Programa Esperanza (Project Hope) a short-term culturally-modified psychosocial intervention for primarily Spanish-speaking Latino patients 55 years of age or older with depression and multiple medical conditions-compared to Enhanced Usual Care (EUC), the alternative choice in real-world care. The study will address the following questions:
Primary Research Question: Among 250 low-income, primarily Spanish-speaking Latinos ≥55 years of age with high medical comorbidity, will Programa Esperanza improve: a) problem solving skills and behavior activation; b) depression-related outcomes; and b) physical functioning compared to EUC over the course of one year?
Exploratory Research Questions:
- Do moderating conditions exist such that the intervention may be more or less effective for some patient subgroups compared to others?
- Will qualitative reports from our patient population and provider stakeholders provide key insights related to treatment effectiveness, acceptance and satisfaction, as well as adoption of the intervention within the patient-centered medical home (PCMH) setting?
- Among patients, interventionists, and organization leaders, are there high feasibility, fidelity, and acceptability of training and deployment of nontraditional interventionists to deliver the psychosocial treatment within the PCMH setting?
Randomized Clinical Trial Design. The study will enroll 250 limited-English-speaking Latinos (55+ years) from the AltaMed Program of All Inclusive Care for the Elderly (PACE), a geriatric patient-centered medical home model in Los Angeles County. Subjects who meet PHQ-9 criteria for depression (i.e., score of 8 or greater) will be randomized to one of two study arms: either individually administered Problem Solving Treatment (PST) sessions (n=125) facilitated by bachelor's-level social workers under the supervision of a licensed clinical social worker; or EUC. Data collected at study enrollment will document past and baseline patient characteristics including baseline depression and depression severity scores. Assessment of depression trial outcomes, i.e., depression symptom level (PHQ-9); depression response and remission rates, and will be taken at 3, 6 and 12 months post randomization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •English or Spanish-speaking Latino age 55 years or older
- •receiving services from any AltaMed PACE site
- •positive for depression (> 8 PHQ-9 score)
排除标准
- •current drinking problems
- •disorders with active mania or psychotic symptoms
- •cognitive impairment precluding ability to give informed consent or participating in the intervention
- •an active medical condition with life expectancy less than 6 months
- •anticipated absences or disenrollment from PACE
研究组 & 干预措施
Problem Solving Treatment
Problem Solving Treatment Individual, face-to-face PST sessions over a span of 8 weeks and 3 monthly booster sessions. The PST protocol is highly structured, time-limited, and manual-driven; sessions include PST hand outs and homework as well as social and behavioral activation strategies.
干预措施: Problem Solving Treatment (Behavioral)
Enhanced Usual Care
Enhanced Usual Care EUC patients will receive psychoeducational materials on depression and depression treatment of older persons. EUC patients will continue to receive the full complement of PACE services (medical, rehabilitation, social) including referrals to specialty mental health services, if indicated.
干预措施: Enhanced Usual Care (Behavioral)
结局指标
主要结局
PHQ-9
时间窗: 3-, 6-, and 12 months
change from initial screening - depressive symptomatology
次要结局
- SCL-20(3-, 6-, and 12 months)
- Performance Oriented Mobility Assessments(3-, 6-, and 12 months)
- Social Problem-Solving Inventory-Revised(3-, 6-, and 12 months)
- PEARLS-Behavioral Activation(3-, 6-, and 12 months)
- Sheehan Disability Scale(3-, 6-, and 12 months)
研究者
Maria P. Aranda
Associate Professor
University of Southern California