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Tertulias Social Isolation Women's Groups Study

Tertulias: Addressing Social Isolation to Reduce Depression Among Women of Mexican Origin

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04254198
Enrollment
241
Registered
2020-02-05
Start date
2020-07-01
Completion date
2024-08-30
Last updated
2025-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression, Social Isolation

Keywords

Immigrant, Women, Peer support group, Community-engaged

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.

Detailed 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.

Interventions

BEHAVIORALTERTULIAS 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.

BEHAVIORALModified 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

Sponsors

National Institutes of Health (NIH)
CollaboratorNIH
National Institute on Minority Health and Health Disparities (NIMHD)
CollaboratorNIH
University of New Mexico
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Randomized Control Trial

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 90 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change in DepressionBaseline, 12 monthsComparison 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.
Change in ResilienceBaseline, 12 monthsComparison 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.
Change in Social SupportBaseline, 12 monthsComparison 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.

Secondary

MeasureTime frameDescription
Change in Perceived StressBaseline, 12 monthsComparison 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
Control
Modified Attention Placebo Control 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
117
TERTULIAS Structured Dialogue Peer Support Groups
Structured Dialogue peer support group 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.
124
Total241

Baseline characteristics

CharacteristicControlTERTULIAS Structured Dialogue Peer Support GroupsTotal
Age, Continuous49.4 years
STANDARD_DEVIATION 10.9
47.6 years
STANDARD_DEVIATION 10.6
48.5 years
STANDARD_DEVIATION 10.8
Depression score (CES-D)16.0 units on a scale
STANDARD_DEVIATION 11.9
16.4 units on a scale
STANDARD_DEVIATION 12
16.2 units on a scale
STANDARD_DEVIATION 11.9
Employed67 Participants77 Participants144 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
117 Participants124 Participants241 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Family or friends living in same location113 Participants120 Participants233 Participants
Marital Status
Married/partnered
75 Participants64 Participants139 Participants
Marital Status
Single/divorced/separated/widowed
42 Participants60 Participants102 Participants
Number of children2.7 children
STANDARD_DEVIATION 1.3
2.7 children
STANDARD_DEVIATION 1.4
2.7 children
STANDARD_DEVIATION 1.3
Overall Health Status
Not well
36 Participants35 Participants71 Participants
Overall Health Status
Well
81 Participants89 Participants170 Participants
Perceived Stress (PSS-14)33.9 units on a scale
STANDARD_DEVIATION 6.6
34.4 units on a scale
STANDARD_DEVIATION 6.5
34.2 units on a scale
STANDARD_DEVIATION 6.5
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
117 Participants124 Participants241 Participants
Region of Enrollment
United States
117 participants124 participants241 participants
Resilience (CD-RISC)82.4 units on a scale
STANDARD_DEVIATION 14.1
80.6 units on a scale
STANDARD_DEVIATION 14.6
81.5 units on a scale
STANDARD_DEVIATION 14.3
Sex: Female, Male
Female
117 Participants124 Participants241 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants
Social Support (MOS-SS)83.7 units on a scale
STANDARD_DEVIATION 15.3
80.3 units on a scale
STANDARD_DEVIATION 17.7
81.9 units on a scale
STANDARD_DEVIATION 16.6
Speaks english52 Participants66 Participants118 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 1170 / 124
other
Total, other adverse events
0 / 1170 / 124
serious
Total, serious adverse events
0 / 1170 / 124

Outcome results

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.

Time frame: Baseline, 12 months

Population: From the Intention-to-Treat (ITT) population, all participants who were randomized and completed the baseline assessment, and who also completed the 12-month follow-up assessment.

ArmMeasureValue (LEAST_SQUARES_MEAN)
ControlChange in Depression-2.01 units on a scale
TERTULIAS structured dialogue peer support groupsChange in Depression-5.10 units on a scale
p-value: 0.047398.3% CI: [-0.0474, 0.509]Mixed Models Analysis
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.

Time frame: Baseline, 12 months

Population: From the Intention-to-Treat (ITT) population, all participants who were randomized and completed the baseline assessment, and who also completed the 12-month follow-up assessment.

ArmMeasureValue (LEAST_SQUARES_MEAN)
ControlChange in Resilience-0.27 units on a scale
TERTULIAS structured dialogue peer support groupsChange in Resilience5.08 units on a scale
p-value: 0.006798.3% CI: [0.0464, 0.72]Mixed Models Analysis
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.

Time frame: Baseline, 12 months

Population: From the Intention-to-Treat (ITT) population, all participants who were randomized and completed the baseline assessment, and who also completed the 12-month follow-up assessment.

ArmMeasureValue (LEAST_SQUARES_MEAN)
ControlChange in Social Support0.45 units on a scale
TERTULIAS structured dialogue peer support groupsChange in Social Support6.56 units on a scale
p-value: 0.000298.3% CI: [-1.215, -0.28]Mixed Models Analysis
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.

Time frame: Baseline, 12 months

Population: From the Intention-to-Treat (ITT) population, all participants who were randomized and completed the baseline assessment, and who also completed the 12-month follow-up assessment.

ArmMeasureValue (LEAST_SQUARES_MEAN)
ControlChange in Perceived Stress-1.36 units on a scale
TERTULIAS structured dialogue peer support groupsChange in Perceived Stress-0.44 units on a scale
p-value: 0.45195% CI: [-3.82, 2]Mixed Models Analysis

Source: ClinicalTrials.gov · Data processed: Feb 16, 2026