Trial Outcomes & Findings for Designing a Mental Health Model for Latina Women (NCT NCT03901430)

Last Updated: 2023-02-06

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

21 participants

Primary outcome timeframe

6 months

Results posted on

2023-02-06

Participant Flow

During month #2 prior to the start of the intervention, Fuentes recruited 30 participants through the Pathways Program, the Simplemente Salud Clinic and Centro Sávila. In the course of regular meetings with clients who request a range of services, she will identify and invite those who might benefit from the proposed model. We also posted flyers at the Clinics and invited potential participants to call Ms. Fuentes to find out more about the study and intervention.

Participant milestones

Participant milestones
Measure	Group Navigation Model Group navigation model: 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.
Overall Study STARTED	21
Overall Study COMPLETED	21
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Designing a Mental Health Model for Latina Women

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Class n=21 Participants Group navigation model Group navigation model: 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	18 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	21 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	21 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Outcome measures

Outcome measures
Measure	Class n=21 Participants Group navigation model Group navigation model: 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.
Depression	13.3 score on a scale Standard Deviation 5.8

Adverse Events

Class

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Julia Hess

University of New Mexico

Phone: 5052724462

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place