Clinical trial NCT03545282: Intervention Trial to Reduce Mental Health Disparities in Latina Immigrant Women
Official title: ALMA: A Randomized Control Trial of an Intervention to Reduce Mental Health Disparities in Mexican Immigrant Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Depression
Anxiety
Keywords: Mental Health
Minority Health
Latina
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2018-06-04
Enrollment: 226
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Depressive Symptoms
timeFrame: Baseline, 2 months after baseline (post-intervention for intervention group), 4 months after baseline, and 6 months after baseline. Outcomes reported at baseline, 2 and 4 months after baseline for both intervention and control groups.
measure: Anxiety Symptoms
timeFrame: Baseline, 2 months after baseline (post-intervention for intervention group), 4 months after baseline, and 6 months after baseline. Outcomes reported at baseline, 2 and 4 months after baseline for both intervention and control groups.
Secondary outcomes:
measure: Stress
timeFrame: Baseline, 2 months after baseline (post-intervention for intervention group), 4 months after baseline, and 6 months after baseline. Outcomes reported at baseline, 2 and 4 months after baseline for both intervention and control groups.
Other outcomes:
measure: Program Satisfaction
timeFrame: Assessed in the intervention group at post-intervention follow-up, 2 months after baseline. In the control group, it was assessed post-intervention, 6 months after baseline.
Locations:
city: Seattle
country: United States
facility: Casa Latina
state: Washington
city: Seattle
country: United States
facility: El Centro de la Raza
state: Washington
Study officials:
affiliation: University of Washington
name: India J Ornelas, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.