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Intervention Trial to Reduce Mental Health Disparities in Latina Immigrant Women

29 de abril de 2022 actualizado 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.

Descripción general del estudio

Estado

Terminado

Descripción detallada

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 estudio

Intervencionista

Inscripción (Actual)

226

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • Washington
      • Seattle, Washington, Estados Unidos, 98144
        • Casa Latina
      • Seattle, Washington, Estados Unidos, 98144
        • El Centro de la Raza

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Femenino

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Prevención
  • Asignación: No aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
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.

Otro: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Depressive Symptoms
Periodo de tiempo: 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
Periodo de tiempo: 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
Change measure (baseline, 4 months, 6 months, 9 months)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Estrés
Periodo de tiempo: Medida de cambio (línea base, 4 meses, 6 meses, 9 meses)
Frecuencia de estrés percibido en el último mes. La Escala de estrés percibido (PSS) es un instrumento clásico de evaluación del estrés. Las puntuaciones individuales en el PSS pueden oscilar entre 0 y 40, y las puntuaciones más altas indican un mayor estrés percibido. Las puntuaciones que oscilan entre 0 y 13 se considerarían de estrés bajo. Las puntuaciones que oscilan entre 14 y 26 se considerarían estrés moderado. Las puntuaciones que oscilan entre 27 y 40 se considerarían estrés percibido alto.
Medida de cambio (línea base, 4 meses, 6 meses, 9 meses)

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Recruitment
Periodo de tiempo: Baseline
Number of participants that are recruited to participate in the study
Baseline
Retention
Periodo de tiempo: 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.
First 9 months after enrollment
Participant Satisfaction
Periodo de tiempo: 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
4 months, 9 months

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: India J Ornelas, PhD, MPH, University of Washington

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

7 de marzo de 2018

Finalización primaria (Actual)

15 de diciembre de 2021

Finalización del estudio (Actual)

1 de enero de 2022

Fechas de registro del estudio

Enviado por primera vez

11 de mayo de 2018

Primero enviado que cumplió con los criterios de control de calidad

22 de mayo de 2018

Publicado por primera vez (Actual)

4 de junio de 2018

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

5 de mayo de 2022

Última actualización enviada que cumplió con los criterios de control de calidad

29 de abril de 2022

Última verificación

1 de abril de 2022

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • STUDY00003331
  • R01MD012230 (Subvención/contrato del NIH de EE. UU.)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

No

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Ensayos clínicos sobre Amigas Latinas Motivando el Alma (ALMA)

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