Tertulias Social Isolation Women's Groups Study

Part of paid clinical trials in Albuquerque, New Mexico.

Sponsor
University of New Mexico
Study ID
NCT04254198
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 90 Years
Healthy Volunteers
Accepted

Interventions

  • TERTULIAS structured dialogue peer support groups — BEHAVIORAL
    TERTULIAS will involve structured dialogue groups using the model developed and tested by the investigators through their preliminary research. Each group will have 10 women and will meet weekly for two hours over a 12-month period. Group meetings will be conducted in Spanish, led by a team of two FMI facilitators. Facilitation will use the structured dialogue approach. In the last two months of each cohort, participants will be invited to write their own stories or recipes, or produce poetry or art representing their experience to share with the group. These contributions will be gathered and reproduced in "booklet" form and each participant will receive a copy.
  • Modified Attention Placebo Control (MAPC) — BEHAVIORAL
    MAPC participants will receive a phone call every other month from the project coordinator to document that their contact information is up to date, to remind them that they are in the study and to tell them that the study is continuing. Survey data and hair samples will be gathered from them at baseline and 12 months

Study Details

This study will use a multi-level, community-engaged approach to implement "TERTULIAS" ("conversational gatherings" in Spanish). The intervention uses an innovative, culturally and contextually situated peer support group design that was developed by the investigators to improve health outcomes and reduce health disparities for female mexican immigrant (FMI) participants in Albuquerque, New Mexico. The study will use a rigorous, transdisciplinary, QUAL⇒QUANT, mixed-method research design. The investigators will document results of the intervention on the primary hypotheses of a decrease in depression, and increases in resilience and social support, as well as on the secondary hypotheses of decreased stress (including the use of innovative testing of hair cortisol as a biomarker for chronic stress), and an increase in social connectedness and positive assessment of knowledge and empowerment gained through the TERTULIAS intervention.

Key Dates

Start date
Jul 1, 2020
Status verified
Sep 2025
Primary completion
Aug 30, 2024
Completion
Aug 30, 2024

Study Design

Enrollment
241 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Control
    Modified Attention Placebo Control
  • Experimental: TERTULIAS structured dialogue peer support groups
    Structured Dialogue peer support group

Primary Outcome Measure

Change in Depression [ Time Frame: Baseline, 12 months ]

Locations (2)

FacilityCityStateZIPSite coordinators
Centro SavilaAlbuquerqueNew Mexico87105-
One Hope Centro De Vida Health CenterAlbuquerqueNew Mexico87108-

Find similar trials in Albuquerque, NM

By condition
Depression
By specialty
PsychiatryMental healthBehavioral health
By research site
Centro Savila· Albuquerque, NMOne Hope Centro De Vida Health Center· Albuquerque, NM

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