Trial results for a study investigating Depression and Social Isolation were posted on ClinicalTrials.gov on 2025-12-01, indicating that the TERTULIAS intervention group experienced a -5.10 unit change in depression, compared to -2.01 in the control group. The study enrolled 241 participants.
Background
Depression is a common mental health condition, often exacerbated by social isolation. For specific populations, such as female Mexican immigrant participants, culturally and contextually relevant interventions are crucial to address health disparities and improve outcomes. Traditional approaches may not fully account for unique social and cultural factors that contribute to mental health challenges and social isolation within these communities. The TERTULIAS intervention was designed as an innovative peer support group model to address these specific needs, aiming to improve health outcomes by fostering community and reducing isolation.
Trial design
This completed study, designated as Phase NA, enrolled 241 participants to investigate conditions including Social Isolation and Depression. The intervention, "TERTULIAS structured dialogue peer support groups," utilized an innovative, culturally and contextually situated peer support group design. Participants were assigned to either the TERTULIAS intervention group or a control group. The study aimed to document the intervention's impact on health outcomes for female Mexican immigrant participants in Albuquerque, New Mexico.
Key results
The trial reported several key measurements and analyses:
- Change in Depression (units on a scale):
- Control group: Least Squares Mean of -2.01 (98.3% Confidence Interval).
- TERTULIAS structured dialogue peer support groups: Least Squares Mean of -5.10 (98.3% Confidence Interval).
- Change in Resilience (units on a scale):
- Control group: Least Squares Mean of -0.27 (98.3% Confidence Interval).
- TERTULIAS structured dialogue peer support groups: Least Squares Mean of 5.08 (98.3% Confidence Interval).
- Change in Social Support (units on a scale):
- Control group: Least Squares Mean of 0.45 (98.3% Confidence Interval).
- TERTULIAS structured dialogue peer support groups: Least Squares Mean of 6.56 (98.3% Confidence Interval).
- Change in Perceived Stress (units on a scale):
- Control group: Least Squares Mean of -1.36 (95% Confidence Interval).
- TERTULIAS structured dialogue peer support groups: Least Squares Mean of -0.44 (95% Confidence Interval).
Key analyses using Mixed Models Analysis also showed:
- A p-value of 0.0473 for a Slope of 0.231 (98.3% Confidence Interval: -0.0474 to 0.509).
- A p-value of 0.0067 for a Slope of 0.383 (98.3% Confidence Interval: 0.0464 to 0.72).
- A p-value of 0.0002 for a Slope of -0.747 (98.3% Confidence Interval: -1.215 to -0.28).
- A p-value of 0.451 for a Slope of -0.913 (95.0% Confidence Interval: -3.82 to 2.0).
What this means
The results suggest that the TERTULIAS structured dialogue peer support groups had a notable positive impact on several key health outcomes. Participants in the TERTULIAS group experienced a greater reduction in depression symptoms and significant increases in both resilience and social support compared to the control group. The statistically significant p-values from the mixed models analyses further support the effectiveness of this culturally and contextually situated intervention. While the change in perceived stress was less pronounced in the intervention group compared to control, the overall findings indicate that such peer support models can be a valuable tool for improving mental health and social well-being, particularly for the target population of female Mexican immigrants experiencing social isolation and depression.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT04254198, titled "Tertulias Social Isolation Women's Groups Study", were posted on 2025-12-01 on clinicaltrials.gov.