Intervention Trial to Reduce Mental Health Disparities in Latina Immigrant Women

Depression Clinical Trial

Official title:

ALMA: A Randomized Control Trial of an Intervention to Reduce Mental Health Disparities in Mexican Immigrant Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03545282
• Other study ID #: STUDY00003331
• Secondary ID: R01MD012230
• Status: Completed
• Phase: N/A
• Start date: September 26, 2018
• Est. completion date: January 1, 2022

Study information

• Verified date: May 2024
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 226
• Est. completion date: January 1, 2022
• Est. primary completion date: December 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety
• Depression
• Stress

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Casa Latina	Seattle	Washington
United States	El Centro de la Raza	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Institute on Minority Health and Health Disparities (NIMHD)

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View 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 Co — View 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/ — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Program Satisfaction	Survey items that ask participant about their level of satisfaction with the program. Response options of 1 - 5, with 5 indicating highest satisfaction (better outcome).	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.
Primary	Depressive Symptoms	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. Higher scores indicate a worse outcome.	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.
Primary	Anxiety Symptoms	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. Higher scores indicate a worse outcome.	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	Stress	Frequency of perceived stress in the last month. The Perceived Stress Scale (PSS) is a classic stress assessment instrument. Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress. Scores ranging from 0-13 would be considered low stress. Scores ranging from 14-26 would be considered moderate stress. Scores ranging from 27-40 would be considered high perceived stress. Higher scores indicate worse outcomes.	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.