Latina Friends Motivating the Soul (ALMA)

Not Applicable

Withdrawn

• Conditions: Stress; Depression; Anxiety
• Interventions: Behavioral: Latina Friends Motivating the Soul (ALMA)

• Registration Number: NCT03749278
• Lead Sponsor: University of Washington

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 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.

Study Timeline

• Study Start: 2018-09-26
• Study First Submitted: 2018-11-13
• Study First Submitted QC: 2018-11-19
• Study First Posted: 2018-11-21
• Primary Completion: 2022-01-01
• Study Completion: 2022-05-31
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-08
• Last Update Posted: 2023-05-10

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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

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Exclusion Criteria

• The investigators will screen for and exclude women who currently have high levels of depressive symptoms (as indicated by a score of 20 or higher on the PHQ-9). If women excluded from the study are not already receiving mental health treatment, the will be referred to mental health providers offering low-cost services in Spanish.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ALMA Delayed Intervention Control Group	Latina Friends Motivating the Soul (ALMA)	Latina Friends Motivating the Soul (ALMA). This group receives the intervention six months after the baseline assessment (after the post-intervention, and 3 month assessments have been completed).
ALMA Intervention Group	Latina Friends Motivating the Soul (ALMA)	Latina Friends Motivating the Soul (ALMA). This group receives the intervention after baseline assessment.

Primary Outcome Measures

Name	Time	Method
Depressive Symptoms	Change measure (baseline, 4 months, 6 months, 9 months)	Frequency of depressive symptoms as measured by the Patient Health Questionnaire 9 (PHQ-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.
Anxiety Symptoms	Change measure (baseline, 4 months, 6 months, 9 months)	Frequency of anxiety symptoms as measured by the General Anxiety Disorders 7 (GAD_\&) 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

Secondary Outcome Measures

Name	Time	Method
Stress	Change measure (baseline, 4 months, 6 months, 9 months)	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.

Trial Locations

Locations (2)

El Centro de la Raza; 🇺🇸 Seattle, Washington, United States

Casa Latina; 🇺🇸 Seattle, Washington, United States