Tertulias Social Isolation Women's Groups Study

Depression Clinical Trial

Official title:

TERTULIAS: Addressing Social Isolation to Reduce Depression Among Female Mexican Immigrants

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04254198
• Other study ID #: 19-160
• Secondary ID: 1R01MD014153-01
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 1, 2020
• Est. completion date: August 30, 2025

Study information

• Verified date: June 2024
• Source: University of New Mexico
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

Description:

Specific Aims. The investigators will conduct a randomized controlled trial with 240 FMIs. Intervention participants will attend a weekly peer group session over 12 months. Control group participants will receive a bimonthly check-in call. All will be surveyed using validated instruments and give hair samples gathered at baseline and 12 months. A subset will be interviewed, and group sessions will be documented. Data will be triangulated using different methods with a QUAL⇒QUAN simultaneous data collection and analysis approach to integrate, converge, and elaborate findings in a way that would not be feasible using only one method.

Aim 1. To measure whether a culturally situated peer group intervention will reduce depression and stress associated with the experience of immigration. Question: Does an intervention design that reproduces culturally important interactions, activities, and constructs lost through immigration result in decreased participant depression and stress? Hypothesis: Incorporating peer-to-peer social interaction, food sharing, and storytelling into the design of a nonclinical peer support group intervention will leverage positive aspects of participant culture and create an experiential context that will (a) decrease participant depression scores by at least 6.5 points more on the Center for Epidemiologic Studies Depression Scale (CES-D) as compared to controls (effect size Cohen's d = 0.43), and (b) lower stress scores in participants more than in controls with d ≥ 0.5 as measured by the Perceived Stress Scale (PSS). The investigators will also assess stress using a cutting-edge biological assessment of hair cortisol as a biomarker for chronic stress.

Aim 2. To test whether an intervention using a "women's funds of knowledge" approach results in improved resilience, knowledge and empowerment. Question: Does an intervention design that encourages participants to share knowledge they developed through life experience and that values this knowledge as a form of expertise nurture protective factors (resilience and knowledge/empowerment) to help FMIs adapt to the immigration context and disrupt the mechanisms that produce health disparities? Hypothesis: Incorporating, valuing and validating women's knowledge and experience in the design of a peer support group intervention will improve participant capacity to adapt to the immigrant context and provide participants with empowering knowledge to deal with new situations. Intervention participants will have higher scores at 12 months and have a larger increase over time as compared to controls (d = 0.5) on the Connor-Davidson Resilience Scale-25 (CD-RISC 25). Knowledge and empowerment will be assessed at 12 months and expect to find high scores with the Trauma-Informed Practice (TIP) Scale (which is designed for post-use).

Aim 3. To investigate whether a culturally situated peer group intervention using a women's funds of knowledge approach can give participants' a sense and experience of social and physical connection ("emplacement") that is lost in the process of immigration. Question: Can the proposed peer support group intervention recreate social and physical connections lost through immigration and strengthen participant social networks? Hypothesis: The peer group will create a culturally appropriate context for establishing interpersonal connections between group members and will give participants a sense of belonging within a social and contextual milieu. At study end, (a) experimental participants will have a marked increase in social support scores v.s. the control group using the Medical Outcomes Study Social Support Survey (MOS SSS) (d ≥ 0.5), and (b) stronger, more dense social connections as described by a social network analysis.

Project Outcomes. This intervention with FMIs will test an innovative intervention to reduce social isolation as a mechanism for reducing depression by leveraging positive cultural dynamics and women's funds of knowledge to nurture social connectedness, knowledge, and resiliency factors in the lives of participants in a transformative way. Generalizability. This trial of TERTULIAS will create a replicable, scalable model for culturally appropriate health promotion with FMIs that has implications for health promotion work with other women from recent and first generation immigrant populations.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 252
• Est. completion date: August 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Over age 18

• Female immigrant

• Born in Mexico

• Reports household income under 250% Federal Poverty Level

• Speaks Spanish fluently

Exclusion Criteria:

• prisoners

• individuals unable to consent

• children

Related Conditions & MeSH terms

• Depression
• Social Isolation

Intervention

Behavioral:
• TERTULIAS structured dialogue peer support groups
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)
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

Locations

Country	Name	City	State
United States	Centro Savila	Albuquerque	New Mexico
United States	One Hope Centro De Vida Health Center	Albuquerque	New Mexico

Sponsors (3)

Lead Sponsor	Collaborator
University of New Mexico	National Institute on Minority Health and Health Disparities (NIMHD), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Change in Perceived Stress	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.	Baseline, 12 months
Secondary	Knowledge and Empowerment at 12 Months (Intervention arm only)	Knowledge and empowerment will be assessed at 12 months in the intervention arm only using the six subscales of the 33-item Trauma-Informed Practice (TIP) Scale as well as a total score across the subscales. The subscales are Agency (9 items), Information (5 items), Connection (3 items), Strengths (3 items), Inclusivity (8 items), and Parenting (5 items) with each item ranging from 0 (not at all true) to 3 (very true). Descriptive statistics will be reported (means and 95% CIs). Higher scores indicate higher levels of knowledge and empowerment associated with the intervention.	12 months
Secondary	Changes in Social Network Density and Characteristics (Intervention arm only)	Results from the following social network analyses (SNA) of the Intervention arm will be "mapped" using UCINET SNA software: 1.) Construct participants' social networks using answers to questions modeled after the General Social Survey. Baseline and 12-month networks will be compared and changes in network density and characteristics will be described. 2.) The level of inclusion of other study participants in individual social networks from baseline to 12 months will be assessed. 3.) Using questions about local resources (e.g., the health insurance exchange, health navigation programs, public food/benefit/clothing programs and charities, free legal assistance programs, low-cost ESL/GED programs, domestic violence programs, transportation/utilities assistance programs, etc.), changes in each study participant's awareness of, knowledge about, and likelihood of accessing resources will be assessed.	Baseline, 12 months