Tertulias Social Isolation Women's Groups Study

NCT04254198 | Completed Results DMC

• 2 other identifiers: 19-1601R01MD014153-01
• Study Type: interventional
• Target: 241
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Social Isolation; Depression

Keywords

Immigrant; Women; Peer support group; Community-engaged

Outcome Measures

Primary Outcomes (3)

• Change in Depression

  Comparison of intervention and control participants of their change in depression scores between baseline and 12 months as measured by the summed scores of the 20-item Center for Epidemiologic Studies Depression Scale (CES-D). Summed scores range from 0 to 100 with higher scores indicating higher levels of depression. Changes will be measured as 12 months - Baseline, so negative change scores indicate decreased depression.

  Baseline, 12 months

• Change in Resilience

  Comparison of intervention and control participants of their change in resilience scores between baseline and 12 months as measured by the summed scores of the 25-item Connor-Davidson Resilience Scale-25 (CD-RISC 25).Summed scores range from 0 to 100 with higher scores indicating higher levels of resilience. Changes will be measured as 12 months - Baseline, so positive change scores indicate increased resilience.

  Baseline, 12 months

• Change in Social Support

  Comparison of intervention and control participants of their change in social support scores between baseline and 12 months as measured by the total scaled scores of the 19-item Medical Outcomes Study Social Support Survey (MOS SSS).Total scaled scores range from 0 to 100 with higher scores indicating higher levels of social support. Changes will be measured as 12 months - Baseline, so positive change scores indicated increased social support.

  Baseline, 12 months

Secondary Outcomes (1)

• Change in Perceived Stress

  Baseline, 12 months

Study Arms (2)

Control

PLACEBO COMPARATOR

Modified Attention Placebo Control

Behavioral: Modified Attention Placebo Control (MAPC)

TERTULIAS structured dialogue peer support groups

EXPERIMENTAL

Structured Dialogue peer support group

Behavioral: TERTULIAS structured dialogue peer support groups

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.

TERTULIAS structured dialogue peer support groups

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

Control

Eligibility Criteria

• Age: 18 Years - 90 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Over age 18
• Female immigrant
• Born in Mexico
• Reports household income under 250% Federal Poverty Level
• Speaks Spanish fluently

You may not qualify if:

• prisoners
• individuals unable to consent
• children

Sponsors & Collaborators

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

Study Sites (2)

Centro Savila

Albuquerque, New Mexico, 87105, United States

Location

One Hope Centro De Vida Health Center

Albuquerque, New Mexico, 87108, United States

Location

Related Publications (1)

• Page-Reeves J, Murray-Krezan C, Regino L, Perez J, Bleecker M, Perez D, Wagner B, Tigert S, Bearer EL, Willging CE. A randomized control trial to test a peer support group approach for reducing social isolation and depression among female Mexican immigrants. BMC Public Health. 2021 Jan 11;21(1):119. doi: 10.1186/s12889-020-09867-z.

  PMID: 33430845 DERIVED

MeSH Terms

Conditions

Social Isolation; Depression

Condition Hierarchy (Ancestors)

Social Behavior; Behavior; Behavioral Symptoms

Results Point of Contact

• Title: Janet Page-Reeves
• Organization: University of New Mexico Health Sciences

JPage-Reeves@salud.unm.edu

505-272-1694

Study Officials

• Janet M Page-Reeves, PhD

  UNM Dept. of Family and Community Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Randomized Control Trial

Study Record Dates

• First Submitted: September 26, 2019
• First Posted: February 5, 2020
• Study Start: July 1, 2020
• Primary Completion: August 30, 2024
• Study Completion: August 30, 2024
• Last Updated: December 1, 2025
• Results First Posted: December 1, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)