Designing a Mental Health Model for Latina Women

NCT03901430 | Completed Results

• 2 other identifiers: 18-305U54MD004811
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to implement such an approach conceptualized by a community health worker (CHW) to pilot an innovative, multi-level intervention to address social and structural determinants that negatively influence MEH disparities for Latinas from low-income households. The proposed research integrates CHW navigation with group peer support. Both of these strategies have been shown to be culturally appropriate and effective for improving a variety of health outcomes with this population. Our transdisciplinary, community-engaged team will use a convergent parallel mixed method research design to assess the feasibility of the intervention and its impact on six domains of interest: 1) emotional support, 2) informational support, 3) depression, 4) social isolation, 5) empowerment, and 6) social determinants needs. To prepare for future extramural funding, the investigators will include development of an advocacy plan for multi-level social change impact.

Conditions

Mental Health Wellness 1; Depression

Outcome Measures

Primary Outcomes (1)

• Depression

  Patient Health Questionnaire-9 (PHQ-9) administered to monitor if intervention changes depression score. PHQ-9 total score for the nine items ranges from 0 to 27. Higher scores indicate increased depression. Scores of 5, 10, 15 and 20 represent cutpoints for mild, moderate, moderately severe and severe depression respectively.

  6 months

Study Arms (1)

Class

EXPERIMENTAL

Group navigation model

Behavioral: Group navigation model

Interventions

Group navigation model BEHAVIORAL

In a series of peer group sessions facilitated by Guadalupe Fuentes, a CHW who designed the model, we will create a culturally-appropriate, non-stigmatizing group intervention. The group process will allow participants to explore their own MEH, better understand the ways that mental health influences well-being and everyday dynamics of their lives, and to develop empowering knowledge and action plans through the support of other women.

Class

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• female over 18 Spanish-speaking economically disadvantaged

You may not qualify if:

• male under 18 non-Spanish-speaking non-economically disadvantaged

Sponsors & Collaborators

• University of New Mexico: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

University of New Mexico

Albuquerque, New Mexico, 87131, United States

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Julia Hess
• Organization: University of New Mexico

jmhess@unm.edu

5052724462

Study Officials

• Lisa Cacari Stone, Ph.D.

  University of New Mexico

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Participants are given ID numbers and all data is coded with ID number
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2019
• First Posted: April 3, 2019
• Study Start: July 1, 2018
• Primary Completion: March 18, 2019
• Study Completion: March 18, 2020
• Last Updated: February 6, 2023
• Results First Posted: February 6, 2023

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)