Trial Outcomes & Findings for Tertulias Social Isolation Women's Groups Study (NCT NCT04254198)
NCT ID: NCT04254198
Last Updated: 2025-11-28
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
241 participants
Primary outcome timeframe
Baseline, 12 months
Results posted on
2025-11-28
Participant Flow
Participant milestones
| Measure |
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
|
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 females of Mexican origin 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.
|
|---|---|---|
|
Overall Study
STARTED
|
117
|
124
|
|
Overall Study
COMPLETED
|
111
|
106
|
|
Overall Study
NOT COMPLETED
|
6
|
18
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Tertulias Social Isolation Women's Groups Study
Baseline characteristics by cohort
| Measure |
Control
n=117 Participants
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
|
TERTULIAS Structured Dialogue Peer Support Groups
n=124 Participants
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.
|
Total
n=241 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49.4 years
STANDARD_DEVIATION 10.9 • n=9 Participants
|
47.6 years
STANDARD_DEVIATION 10.6 • n=6 Participants
|
48.5 years
STANDARD_DEVIATION 10.8 • n=9 Participants
|
|
Sex: Female, Male
Female
|
117 Participants
n=9 Participants
|
124 Participants
n=6 Participants
|
241 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
117 Participants
n=9 Participants
|
124 Participants
n=6 Participants
|
241 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
117 Participants
n=9 Participants
|
124 Participants
n=6 Participants
|
241 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Region of Enrollment
United States
|
117 participants
n=9 Participants
|
124 participants
n=6 Participants
|
241 participants
n=9 Participants
|
|
Marital Status
Married/partnered
|
75 Participants
n=9 Participants
|
64 Participants
n=6 Participants
|
139 Participants
n=9 Participants
|
|
Marital Status
Single/divorced/separated/widowed
|
42 Participants
n=9 Participants
|
60 Participants
n=6 Participants
|
102 Participants
n=9 Participants
|
|
Number of children
|
2.7 children
STANDARD_DEVIATION 1.3 • n=9 Participants
|
2.7 children
STANDARD_DEVIATION 1.4 • n=6 Participants
|
2.7 children
STANDARD_DEVIATION 1.3 • n=9 Participants
|
|
Family or friends living in same location
|
113 Participants
n=9 Participants
|
120 Participants
n=6 Participants
|
233 Participants
n=9 Participants
|
|
Speaks english
|
52 Participants
n=9 Participants
|
66 Participants
n=6 Participants
|
118 Participants
n=9 Participants
|
|
Employed
|
67 Participants
n=9 Participants
|
77 Participants
n=6 Participants
|
144 Participants
n=9 Participants
|
|
Overall Health Status
Well
|
81 Participants
n=9 Participants
|
89 Participants
n=6 Participants
|
170 Participants
n=9 Participants
|
|
Overall Health Status
Not well
|
36 Participants
n=9 Participants
|
35 Participants
n=6 Participants
|
71 Participants
n=9 Participants
|
|
Depression score (CES-D)
|
16.0 units on a scale
STANDARD_DEVIATION 11.9 • n=9 Participants
|
16.4 units on a scale
STANDARD_DEVIATION 12.0 • n=6 Participants
|
16.2 units on a scale
STANDARD_DEVIATION 11.9 • n=9 Participants
|
|
Resilience (CD-RISC)
|
82.4 units on a scale
STANDARD_DEVIATION 14.1 • n=9 Participants
|
80.6 units on a scale
STANDARD_DEVIATION 14.6 • n=6 Participants
|
81.5 units on a scale
STANDARD_DEVIATION 14.3 • n=9 Participants
|
|
Social Support (MOS-SS)
|
83.7 units on a scale
STANDARD_DEVIATION 15.3 • n=9 Participants
|
80.3 units on a scale
STANDARD_DEVIATION 17.7 • n=6 Participants
|
81.9 units on a scale
STANDARD_DEVIATION 16.6 • n=9 Participants
|
|
Perceived Stress (PSS-14)
|
33.9 units on a scale
STANDARD_DEVIATION 6.6 • n=9 Participants
|
34.4 units on a scale
STANDARD_DEVIATION 6.5 • n=6 Participants
|
34.2 units on a scale
STANDARD_DEVIATION 6.5 • n=9 Participants
|
PRIMARY outcome
Timeframe: Baseline, 12 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Control
n=111 Participants
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
|
TERTULIAS structured dialogue peer support groups
n=106 Participants
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.
|
|---|---|---|
|
Change in Depression
|
-2.01 units on a scale
Interval -4.7 to 0.69
|
-5.10 units on a scale
Interval -7.85 to -2.35
|
PRIMARY outcome
Timeframe: Baseline, 12 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Control
n=111 Participants
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
|
TERTULIAS structured dialogue peer support groups
n=106 Participants
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.
|
|---|---|---|
|
Change in Resilience
|
-0.27 units on a scale
Interval -3.68 to 3.15
|
5.08 units on a scale
Interval 1.68 to 8.48
|
PRIMARY outcome
Timeframe: Baseline, 12 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Control
n=111 Participants
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
|
TERTULIAS structured dialogue peer support groups
n=106 Participants
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.
|
|---|---|---|
|
Change in Social Support
|
0.45 units on a scale
Interval -3.47 to 4.37
|
6.56 units on a scale
Interval 2.34 to 10.77
|
SECONDARY outcome
Timeframe: Baseline, 12 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Control
n=111 Participants
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
|
TERTULIAS structured dialogue peer support groups
n=106 Participants
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.
|
|---|---|---|
|
Change in Perceived Stress
|
-1.36 units on a scale
Interval -3.04 to 0.33
|
-0.44 units on a scale
Interval -2.13 to 1.24
|
Adverse Events
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
TERTULIAS structured dialogue peer support groups
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Janet Page-Reeves
University of New Mexico Health Sciences
Phone: 505-272-1694
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place