Intervention Trial to Reduce Mental Health Disparities in Latina Immigrant Women

NCT ID: NCT03545282

Last Updated: 2024-05-24

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

226 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-26

Study Completion Date

2022-01-01

Brief Summary

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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

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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.

Conditions

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Stress Depression Anxiety

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
The investigators and outcomes assessor will not have knowledge of the interventions assigned to individual participants.

Study Groups

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ALMA Intervention Group

Amigas Latinas Motivando el Alma (ALMA). This group receives the intervention after baseline assessment.

Group Type EXPERIMENTAL

Amigas Latinas Motivando el Alma (ALMA)

Intervention Type BEHAVIORAL

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.

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).

Group Type OTHER

Amigas Latinas Motivando el Alma (ALMA)

Intervention Type BEHAVIORAL

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.

Interventions

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Amigas Latinas Motivando el Alma (ALMA)

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role collaborator

University of Washington

OTHER

Sponsor Role lead

Responsible Party

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India Ornelas

Associate Professor, School of Public Health

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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India J Ornelas, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

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Casa Latina

Seattle, Washington, United States

Site Status

El Centro de la Raza

Seattle, Washington, United States

Site Status

Countries

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United States

References

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Abarca GJ, Tornberg-Belanger SN, Ryan D, Price C, Rao D, Ornelas IJ. Understanding the Relationship Between Social Stressors, Trauma, and Somatic Symptoms Among Latina Immigrant Women. J Racial Ethn Health Disparities. 2023 Feb;10(1):387-394. doi: 10.1007/s40615-022-01230-9. Epub 2022 Mar 7.

Reference Type BACKGROUND
PMID: 35257311 (View on PubMed)

Ornelas IJ, Tornberg-Belanger S, Balkus JE, Bravo P, Perez Solorio SA, Perez GE, Tran AN. Coping With COVID-19: The Impact of the Pandemic on Latina Immigrant Women's Mental Health and Well-being. Health Educ Behav. 2021 Dec;48(6):733-738. doi: 10.1177/10901981211050638. Epub 2021 Oct 21.

Reference Type BACKGROUND
PMID: 34672827 (View on PubMed)

Ryan D, Tornberg-Belanger SN, Perez G, Maurer S, Price C, Rao D, Chan KCG, Ornelas IJ. Stress, social support and their relationship to depression and anxiety among Latina immigrant women. J Psychosom Res. 2021 Oct;149:110588. doi: 10.1016/j.jpsychores.2021.110588. Epub 2021 Jul 30.

Reference Type BACKGROUND
PMID: 34371256 (View on PubMed)

Ornelas IJ, Rao D, Price C, Chan G, Tran A, Aisenberg G, Perez G, Maurer S, Nelson AK. Promoting mental health in Latina immigrant women: Results from the Amigas Latinas Motivando el Alma intervention trial. Soc Sci Med. 2023 Mar;321:115776. doi: 10.1016/j.socscimed.2023.115776. Epub 2023 Feb 16.

Reference Type RESULT
PMID: 36809698 (View on PubMed)

Ornelas IJ, Perez G, Maurer S, Gonzalez S, Childs V, Price C, Nelson AK, Perez Solorio SA, Tran A, Rao D. Amigas Latinas Motivando el Alma: In-Person and Online Delivery of an Intervention to Promote Mental Health Among Latina Immigrant Women. J Integr Complement Med. 2022 Oct;28(10):821-829. doi: 10.1089/jicm.2022.0491. Epub 2022 Jun 20.

Reference Type RESULT
PMID: 35723668 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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R01MD012230

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00003331

Identifier Type: -

Identifier Source: org_study_id

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