NCT03749278

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 26, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 13, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 21, 2018

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2022

Completed
Last Updated

May 10, 2023

Status Verified

May 1, 2023

Enrollment Period

3.3 years

First QC Date

November 13, 2018

Last Update Submit

May 8, 2023

Conditions

StressDepressionAnxiety

Keywords

Mental HealthMinority HealthLatina

Outcome Measures

Primary Outcomes (2)

  • Depressive Symptoms

    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.

    Change measure (baseline, 4 months, 6 months, 9 months)

  • Anxiety Symptoms

    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

    Change measure (baseline, 4 months, 6 months, 9 months)

Secondary Outcomes (1)

  • Stress

    Change measure (baseline, 4 months, 6 months, 9 months)

Study Arms (2)

ALMA Intervention Group

EXPERIMENTAL

Latina Friends Motivating the Soul (ALMA). This group receives the intervention after baseline assessment.

Behavioral: Latina Friends Motivating the Soul (ALMA)

ALMA Delayed Intervention Control Group

ACTIVE COMPARATOR

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).

Behavioral: Latina Friends Motivating the Soul (ALMA)

Interventions

Latina Friends Motivating the Soul (ALMA)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

ALMA Delayed Intervention Control GroupALMA Intervention Group

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsMen will not be included in the study. Participation is limited to this population because the research question addressed is relevant only to Latina women and the mental health concerns of this community.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Casa Latina

Seattle, Washington, 98144, United States

Location

El Centro de la Raza

Seattle, Washington, 98144, United States

Location

Related Publications (2)

  • Miranda MM, Rao D, Price C, Gudino J, Perez G, Maurer S, Nelson AK, Perez-Solorio SA, Ornelas IJ. Amigas Latinas Motivando el Alma: Participant Perspectives on an In-Person and Online Implementation of an Intervention to Promote Mental Health in Latina Immigrant Women. Community Ment Health J. 2024 Jul;60(5):908-918. doi: 10.1007/s10597-024-01244-z. Epub 2024 Mar 2.

    PMID: 38430288DERIVED

  • 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.

    PMID: 35723668DERIVED

MeSH Terms

Conditions

DepressionAnxiety DisordersPsychological Well-Being

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental DisordersPersonal Satisfaction

Study Officials

  • India J Ornelas, PhD, MPH

    University of Washington

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The investigator and outcomes assessor will not have knowledge of the intervention assigned to individual participants
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, School of Public Health

Study Record Dates

First Submitted

November 13, 2018

First Posted

November 21, 2018

Study Start

September 26, 2018

Primary Completion

January 1, 2022

Study Completion

May 31, 2022

Last Updated

May 10, 2023

Record last verified: 2023-05

Locations

US(2)