Intervention Trial to Reduce Mental Health Disparities in Latina Immigrant Women
29 de abril de 2022 atualizado por: India Ornelas, University of Washington
ALMA: A Randomized Control Trial of an Intervention to Reduce Mental Health Disparities in Mexican Immigrant Women
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.
Visão geral do estudo
Status
Concluído
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Intervencional
Inscrição (Real)
226
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
-
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Washington
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Seattle, Washington, Estados Unidos, 98144
- Casa Latina
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Seattle, Washington, Estados Unidos, 98144
- El Centro de la Raza
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-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Fêmea
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: ALMA Intervention Group
Amigas Latinas Motivando el Alma (ALMA).
This group receives the intervention after baseline assessment.
|
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. |
|
Outro: 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).
|
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. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Depressive Symptoms
Prazo: Change measure (baseline, 4 months, 6 months, 9 months)
|
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.
|
Change measure (baseline, 4 months, 6 months, 9 months)
|
|
Anxiety Symptoms
Prazo: Change measure (baseline, 4 months, 6 months, 9 months)
|
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)
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Estresse
Prazo: Medida de mudança (linha de base, 4 meses, 6 meses, 9 meses)
|
Frequência de estresse percebido no último mês.
A Perceived Stress Scale (PSS) é um instrumento clássico de avaliação do estresse.
As pontuações individuais no PSS podem variar de 0 a 40, com pontuações mais altas indicando maior estresse percebido.
Pontuações variando de 0 a 13 seriam consideradas de baixo estresse.
Pontuações variando de 14 a 26 seriam consideradas estresse moderado.
Pontuações variando de 27 a 40 seriam consideradas estresse percebido alto.
|
Medida de mudança (linha de base, 4 meses, 6 meses, 9 meses)
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Recruitment
Prazo: Baseline
|
Number of participants that are recruited to participate in the study
|
Baseline
|
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Retention
Prazo: First 9 months after enrollment
|
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
Prazo: 4 months, 9 months
|
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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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: India J Ornelas, PhD, MPH, University of Washington
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
7 de março de 2018
Conclusão Primária (Real)
15 de dezembro de 2021
Conclusão do estudo (Real)
1 de janeiro de 2022
Datas de inscrição no estudo
Enviado pela primeira vez
11 de maio de 2018
Enviado pela primeira vez que atendeu aos critérios de CQ
22 de maio de 2018
Primeira postagem (Real)
4 de junho de 2018
Atualizações de registro de estudo
Última Atualização Postada (Real)
5 de maio de 2022
Última atualização enviada que atendeu aos critérios de controle de qualidade
29 de abril de 2022
Última verificação
1 de abril de 2022
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- STUDY00003331
- R01MD012230 (Concessão/Contrato do NIH dos EUA)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Não
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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