Clinical trial NCT04254198: Tertulias Social Isolation Women's Groups Study
Official title: TERTULIAS: Addressing Social Isolation to Reduce Depression Among Female Mexican Immigrants
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Social Isolation
Depression
Keywords: Immigrant
Women
Peer support group
Community-engaged
Lead sponsor: University of New Mexico
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2020-02-05
Enrollment: 252
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Control Trial
Primary purpose: TREATMENT

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Depression
timeFrame: Baseline, 12 months
measure: Change in Resilience
timeFrame: Baseline, 12 months
measure: Change in Social Support
timeFrame: Baseline, 12 months
Secondary outcomes:
measure: Change in Perceived Stress
timeFrame: Baseline, 12 months
measure: Knowledge and Empowerment at 12 Months (Intervention arm only)
timeFrame: 12 months
measure: Changes in Social Network Density and Characteristics (Intervention arm only)
timeFrame: Baseline, 12 months
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: Centro Savila
state: New Mexico
city: Albuquerque
country: United States
facility: One Hope Centro De Vida Health Center
state: New Mexico
Study officials:
affiliation: UNM Dept. of Family and Community Medicine
name: Janet M Page-Reeves, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.