NCT04254198

Tertulias Social Isolation Women's Groups Study

Completed NA Results posted Last updated 1 December 2025

What this trial tests

NA trial testing TERTULIAS structured dialogue peer support groups in Social Isolation in 241 participants. Completed in 30 August 2024.

Timeline

1 July 2020

Primary endpoint
30 August 2024

30 August 2024

Quick facts

Lead sponsor	University of New Mexico
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	241
Start date	1 July 2020
Primary completion	30 August 2024
Estimated completion	30 August 2024
Sites	2 locations across United States

Drugs / interventions tested

• TERTULIAS structured dialogue peer support groups
• Modified Attention Placebo Control (MAPC)

Conditions studied

• Social Isolation — all drugs for Social Isolation →
• Depression — all drugs for Depression →

Sponsor

University of New Mexico

Who can join

Adults 18 to 90, female only, with Social Isolation or Depression. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Depression Primary · Baseline, 12 months

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.

Group	Value	95% CI
Control	-2.01	-4.70 – 0.69
TERTULIAS structured dialogue peer support groups	-5.10	-7.85 – -2.35

Change in Resilience Primary · Baseline, 12 months

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.

Group	Value	95% CI
Control	-0.27	-3.68 – 3.15
TERTULIAS structured dialogue peer support groups	5.08	1.68 – 8.48

Change in Social Support Primary · Baseline, 12 months

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.

Group	Value	95% CI
Control	0.45	-3.47 – 4.37
TERTULIAS structured dialogue peer support groups	6.56	2.34 – 10.77

Change in Perceived Stress Secondary · Baseline, 12 months

Comparison of intervention and control participants of their change in social support scores between baseline and 12 months as measured by the summed scores of the 14-item Perceived Stress Scale (PSS-14). Summed scores range from 0 to 56 with higher scores indicating higher levels of stress. Changes will be measured as 12 months - Baseline, so negative change scores indicate decreased perceived stress.

Group	Value	95% CI
Control	-1.36	-3.04 – 0.33
TERTULIAS structured dialogue peer support groups	-0.44	-2.13 – 1.24

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. A randomized control trial to test a peer support group approach for reducing social isolation and depression among female Mexican immigrants.
   Page-Reeves J, Murray-Krezan C, Regino L, Perez J, et al · · 2021 · cited 16× · PMID 33430845 · DOI 10.1186/s12889-020-09867-z