ALMA: A Randomized Control Trial of an Intervention to Reduce Mental Health Disparities in Mexican Immigrant Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 226
- 试验地点
- 4
- 主要终点
- Depressive Symptoms
研究概览
简要总结
Latina immigrant women are particularly vulnerable to depression and anxiety due to the social and economic stressors they face, including high levels of poverty, low levels of education, family obligations, exposure to violence, and limited access to community resources. ALMA aims to prevent and reduce depression and anxiety among Latina immigrant women. Women attend 8 weekly sessions in a group format to teach and encourage women to use coping strategies to reduce depression and anxiety. The intervention aims to increase participants' social ties and the social support they receive from other Latina immigrant women. The program also helps decrease the stigma associated with mental health and connects women to mental health services when needed.
详细描述
The proposed study aims to test the efficacy of the Amigas Latinas Motivando el Alma (ALMA) intervention in a randomized control trial. ALMA is an 8-week program offered in a group format to teach women new coping strategies and enhance their social ties and social support to prevent and reduce their depression and anxiety. Aim 1 of the proposed study is to refine the ALMA intervention and study procedures, using information learned from focus groups and cognitive interviews with Mexican immigrant women. Aim 2 is to determine the efficacy of the ALMA intervention to reduce depressive and anxiety symptoms using a randomized control study design. We will recruit women from community-based organizations serving Latino immigrants to participate in the program, which will be offered in community settings. We will assess process outcomes of recruitment, retention, fidelity, and participant satisfaction through observations and in-depth interviews with participants. We will assess the efficacy of the intervention by comparing changes in women's depressive and anxiety symptoms in the intervention and attention control groups at four time points (pre-intervention, post-intervention, 6 months, 9 months). Aim 3 is to assess the potential impact of the intervention on both individual (stigma, stress, coping strategies) and interpersonal (social support, social ties) factors, and whether the impact of the intervention is mediated by these factors. The research team includes investigators in psychology, medicine, social work and public health, as well as community-based organizations serving Latina immigrants. The study uses rigorous methods to test an innovative program that integrates both culturally relevant and evidenced-based strategies to address significant mental health disparities in a high-risk and underserved population. Findings will help inform future research and practice. Given the growth of the Latino population, identifying interventions that reduce mental health disparities among Mexican immigrant women can have a significant public health impact.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
The investigators and outcomes assessor will not have knowledge of the interventions assigned to individual participants.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •To be eligible for study participation, participants must be at least 18 years of age, female, speak Spanish, must self-identify as Latina, and have been born outside of the United States.
排除标准
- •Participant screened for high levels of depressive symptoms (as indicated by a score of 20 or higher on the PHQ-9) which indicates severe symptoms. Participants with scores above 20 were referred to the licensed mental health counselor on the study team. If these women are not already receiving mental health treatment, they will be referred to mental health providers offering low-cost services in Spanish. The counselor will discuss participation in the program with the potential participants and make the final determination about their ability to participate based on the care they are currently receiving and the severity of their symptoms.
结局指标
主要结局
Depressive Symptoms
时间窗: Baseline, 2 months after baseline (post-intervention for intervention group), 4 months after baseline, and 6 months after baseline. Outcomes reported at baseline, 2 and 4 months after baseline for both intervention and control groups.
Frequency of depressive symptoms as measured by the Patient Health Questionnaire 9 in the last two weeks. The PHQ-9 is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression. Scores range from 0 to 27. In general, a total of 10 or above is suggestive of the presence of depression. Depression Severity: 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe. Higher scores indicate a worse outcome.
Anxiety Symptoms
时间窗: Baseline, 2 months after baseline (post-intervention for intervention group), 4 months after baseline, and 6 months after baseline. Outcomes reported at baseline, 2 and 4 months after baseline for both intervention and control groups.
Frequency of anxiety symptoms as measured by the General Anxiety Disorders 7 in the last two weeks. Generalized Anxiety Disorder 7 (GAD-7) is a self-reported questionnaire for screening and severity measuring of generalized anxiety disorder (GAD). Scores range from 0 to 21. Scores ≥10. Anxiety Severity: 1-4 minimal symptoms, 5-9 mild symptoms, 10-14 moderate symptoms, 15-21 severe symptoms. Higher scores indicate a worse outcome.
次要结局
- Stress(Baseline, 2 months after baseline (post-intervention for intervention group), 4 months after baseline, and 6 months after baseline. Outcomes reported at baseline, 2 and 4 months after baseline for both intervention and control groups.)
研究者
India Ornelas
Associate Professor, School of Public Health
University of Washington