Reducing Stress, Anxiety, and Depressive Symptoms Via a Family-centered Preventative Intervention for Immigrants: A Randomized Controlled Feasibility Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 232
- 试验地点
- 2
- 主要终点
- Cohen Perceived Stress Scale to Measure Stress
研究概览
简要总结
Goal: The long-term goal of the proposed research program is to test the effectiveness of a preventative behavioral intervention and to scale it up for use with broader immigrant populations to reduce stress and mental health disorders.
Intervention: This study plan to adapt the World Health Organization developed Problem Management Plus (PMP), an evidence based, multi-component, behavioral intervention including breathing, problem solving, behavioral activation, and social support for immigrants.
Hypothesis: Immigrants in the Problem Management Plus for Immigrants (PMP-I) will have significantly lower levels of stress and anxious/depressive symptoms as compared to immigrants in the talk program with Community Support Service pamphlets (CSS).
Objective: The current study aims to pilot test the feasibility and acceptability of PMP-I among Bhutanese immigrants 18 years and older living in the Massachusetts.
详细描述
Problem Management Plus (PMP) is a low-intensity evidence-based psychological intervention developed by World Health Organization that can be delivered by trained lay people. PMP systematically teaches four strategies: stress management through breathing exercises, problem solving, behavioral activation, and skills to strengthen social support at individual level. The current study plans to adapt PMP to develop the PMP for Immigrants (PMP-I) for a family setting to address immigrant's multiple social and emotional stressors while adjusting into the new multi-cultural environment of the United States. The rationale to adapt PMP is based on our intervention model that demands integration of social and emotional stressors; promising results of PMP; strong evidence of family and community ties in health care process; and growing consensus among community, scientists, and policymakers on the need for family-based care models that are sustainable. PMP-I is a 5-week, peer-led, culturally tailored mental health promotion program that includes psychoeducation, behavioral activation, and problem solving (90 minutes/session/weekly), and breathing exercises and yoga (90 minutes/session/weekly) in a family setting. Participating families will be randomly allocated into two groups (N=116 families (232 participants: two eligible members per family); 58 families per intervention (PMP-I) and control (CSS)) with assessments at baseline, post-intervention, and 3-month post-intervention with trained community facilitators in collaboration with church leaders.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- 是
入选标准
- •Bhutanese adult 18 years or older resettled in Massachusetts
- •Have a score of 14 or below on the Patient Health Questionnaire (PHQ-9)
排除标准
- •Have a PHQ-9 score of 15 or above
- •Clinically diagnosed mental health disorders
- •Taking psychiatric medications for any mental health problems
结局指标
主要结局
Cohen Perceived Stress Scale to Measure Stress
时间窗: Baseline
The 10-item Cohen Perceived Stress Scale will be used to assess perceived stress at baseline, post-intervention, and 12-week post-intervention. The Cohen Perceived Stress Scale uses a 5-point Likert scale (ranging from 0, "never" to 4, "very often") to assess psychological stress experienced during the past four weeks, including the extent to which situations felt unpredictable, uncomfortable, and overwhelming. The total high scores indicate a worse outcome. The score range is between 0 and 40.
Hopkins Symptom Checklist-25 to Measure Anxiety
时间窗: Baseline
The Hopkins Symptom Checklist-25 (HSCL-25) will be used to measure anxiety and depressive symptoms experienced over the past four weeks at baseline, post-intervention, and 12-week post-intervention. It is composed of a 10-item subscale for anxiety and a 15-item subscale for depression, with each item scored on a Likert scale from 1 (not at all) to 4 (extremely). The higher scores indicate high anxiety or depressive symptoms. The scores range for anxiety between 10 and 40 and depressive symptoms between 15 and 60.
Hopkins Symptom Checklist-25 to Measure Depressive Symptoms
时间窗: Baseline
The Hopkins Symptom Checklist-25 (HSCL-25) will be used to measure anxiety and depressive symptoms experienced over the past four weeks at baseline, post-intervention, and 12-week post-intervention. It is composed of a 10-item subscale for anxiety and a 15-item subscale for depression, with each item scored on a Likert scale from 1 (not at all) to 4 (extremely). The higher scores indicate high anxiety or depressive symptoms. The scores range for anxiety between 10 and 40 and depressive symptoms between 15 and 60.
次要结局
- Hair Cortisol Concentrations (pg/mg)(Baseline)
研究者
Kalpana Poudel-Tandukar
Assistant Professor
University of Massachusetts, Amherst