Clinical Trial Details
— Status: Withdrawn
Administrative data
NCT number |
NCT03749278 |
Other study ID # |
STUDY00005476 |
Secondary ID |
R01MD012230 |
Status |
Withdrawn |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
September 26, 2018 |
Est. completion date |
May 31, 2022 |
Study information
Verified date |
May 2023 |
Source |
University of Washington |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
Description:
The proposed study aims to test the efficacy of the Latina Friends Motivating the Soul (ALMA)
intervention in a delayed intervention 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 2 is to determine the
efficacy of the ALMA intervention to reduce depressive and anxiety symptoms using a delayed
intervention control study design. The investigators will recruit women from community-based
organizations serving Latino immigrants to participate in the program, which will be offered
in community settings. The investigators will assess process outcomes of recruitment,
retention, fidelity, and participant satisfaction through observations and in-depth
interviews with participants. The investigators 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 (baseline, 3-month follow-up, 6-month follow-up,
and 9-month follow-up). 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.