Viewing Study NCT03545282



Ignite Creation Date: 2024-05-06 @ 11:32 AM
Last Modification Date: 2024-10-26 @ 12:46 PM
Study NCT ID: NCT03545282
Status: COMPLETED
Last Update Posted: 2024-05-24
First Post: 2018-05-11

Brief Title: Intervention Trial to Reduce Mental Health Disparities in Latina Immigrant Women
Sponsor: University of Washington
Organization: University of Washington

Study Overview

Official Title: ALMA A Randomized Control Trial of an Intervention to Reduce Mental Health Disparities in Mexican Immigrant Women
Status: COMPLETED
Status Verified Date: 2024-05
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: 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
Detailed Description: 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 womens 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
R01MD012230 NIH None httpsreporternihgovquickSearchR01MD012230