Intervention Trial to Reduce Mental Health Disparities in Latina Immigrant Women
ALMA: A Randomized Control Trial of an Intervention to Reduce Mental Health Disparities in Mexican Immigrant Women
研究概览
详细说明
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Washington
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Seattle、Washington、美国、98144
- Casa Latina
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Seattle、Washington、美国、98144
- El Centro de la Raza
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
学习计划
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:非随机化
- 介入模型:并行分配
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:ALMA Intervention Group
Amigas Latinas Motivando el Alma (ALMA).
This group receives the intervention after baseline assessment.
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In a series of 8 weekly sessions, the program uses a group format to teach and encourage women to use coping strategies to reduce depression and anxiety. Over the course of the eight ALMA sessions, 25 women are (1) engaged in activities to identify coping strategies they are currently using and encouraged to continue to use them; (2) introduced to new coping strategies (e.g. mindfulness techniques, increased social ties and social support); and, (3) provided resources for seeking additional help if needed. Due to COVID-19 pandemic, the intervention was changed to online synchronous delivery via Zoom over 6 weekly sessions. |
其他:ALMA Delayed Intervention Control Group
Amigas Latinas Motivando el Alma (ALMA).
This group receives the intervention five months after the baseline assessment (after the post-intervention, and 3 month assessments have been completed).
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In a series of 8 weekly sessions, the program uses a group format to teach and encourage women to use coping strategies to reduce depression and anxiety. Over the course of the eight ALMA sessions, 25 women are (1) engaged in activities to identify coping strategies they are currently using and encouraged to continue to use them; (2) introduced to new coping strategies (e.g. mindfulness techniques, increased social ties and social support); and, (3) provided resources for seeking additional help if needed. Due to COVID-19 pandemic, the intervention was changed to online synchronous delivery via Zoom over 6 weekly sessions. |
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Depressive Symptoms
大体时间:Change measure (baseline, 4 months, 6 months, 9 months)
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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.
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Change measure (baseline, 4 months, 6 months, 9 months)
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Anxiety Symptoms
大体时间:Change measure (baseline, 4 months, 6 months, 9 months)
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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
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Change measure (baseline, 4 months, 6 months, 9 months)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
压力
大体时间:变化测量(基线、4 个月、6 个月、9 个月)
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上个月感知压力的频率。
感知压力量表 (PSS) 是一种经典的压力评估工具。
PSS 的个人分数范围为 0 到 40,分数越高表示感知到的压力越大。
0-13 之间的分数将被视为低压力。
分数范围为 14-26 将被视为中度压力。
27-40 的分数将被视为高感知压力。
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变化测量(基线、4 个月、6 个月、9 个月)
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Recruitment
大体时间:Baseline
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Number of participants that are recruited to participate in the study
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Baseline
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Retention
大体时间:First 9 months after enrollment
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Number of participant that complete study procedures, including intervention sessions and surveys.
Satisfactory retention is defined as 80% of participants complete survey and 75% attending at least half of the intervention sessions.
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First 9 months after enrollment
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Participant Satisfaction
大体时间:4 months, 9 months
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Survey items related to program logistics such as convenience for participants, perception of facilitators, connection with other participants, and perceived efficacy of the intervention.
Response options of 1 - 5, with 5 indicating highest satisfaction
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4 months, 9 months
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合作者和调查者
调查人员
- 首席研究员:India J Ornelas, PhD, MPH、University of Washington
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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