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Trial record 27 of 229 for:    Recruiting, Not yet recruiting, Available Studies | "Mental Health"

Randomized Trial to Reduce Mental Health Disparities in Latina Immigrant Women

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ClinicalTrials.gov Identifier: NCT03545282
Recruitment Status : Recruiting
First Posted : June 4, 2018
Last Update Posted : June 5, 2018
Sponsor:
Collaborator:
National Institute on Minority Health and Health Disparities (NIMHD)
Information provided by (Responsible Party):
India Ornelas, 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.

Condition or disease Intervention/treatment Phase
Stress Depression Anxiety Behavioral: Amigas Latinas Motivando el Alma (ALMA) Not Applicable

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, 3 months, 6 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: The investigators and outcomes assessor will not have knowledge of the interventions assigned to individual participants.
Primary Purpose: Prevention
Official Title: ALMA: A Randomized Control Trial of an Intervention to Reduce Mental Health Disparities in Mexican Immigrant Women
Actual Study Start Date : March 7, 2018
Estimated Primary Completion Date : October 1, 2021
Estimated Study Completion Date : May 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ALMA Intervention Group
Amigas Latinas Motivando el Alma (ALMA). This group receives the intervention after baseline assessment.
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.

ALMA Delayed Intervention Control Group
Amigas Latinas Motivando el Alma (ALMA). This group receives the intervention five months after the baseline assessment (after the post-intervention, and 3 month assessments have been completed).
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.




Primary Outcome Measures :
  1. Depressive Symptoms [ Time Frame: Change measure (baseline, 4 months, 6 months, 9 months) ]
    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.

  2. Anxiety Symptoms [ Time Frame: Change measure (baseline, 4 months, 6 months, 9 months) ]
    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


Secondary Outcome Measures :
  1. Stress [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Men 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.
Accepts Healthy Volunteers:   Yes
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:

  • Participants with the following conditions: substance abuse or dependence, suicidal ideation or tendencies, psychosis, seizure disorders, or dementia. Expression or history of these conditions will excluded participation in the intervention and lead to a referral to an appropriate mental health agency/provider.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03545282


Contacts
Contact: Georgina E Perez, MSW, LICSW 206-543-9932 geperez@uw.edu

Locations
United States, Washington
Casa Latina Recruiting
Seattle, Washington, United States, 98144
Contact: Marcos Martinez    206-686-2620    marcos@casa-latina.org   
El Centro de la Raza Recruiting
Seattle, Washington, United States, 98144
Contact: Estela Ortega    206-957-4613    eortega@elcentrodelaraza.org   
Sponsors and Collaborators
University of Washington
National Institute on Minority Health and Health Disparities (NIMHD)
Investigators
Principal Investigator: India J Ornelas, PhD, MPH University of Washington

Responsible Party: India Ornelas, Associate Professor, School of Public Health, University of Washington
ClinicalTrials.gov Identifier: NCT03545282     History of Changes
Other Study ID Numbers: STUDY00003331
R01MD012230 ( U.S. NIH Grant/Contract )
First Posted: June 4, 2018    Key Record Dates
Last Update Posted: June 5, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by India Ornelas, University of Washington:
Mental Health
Minority Health
Latina