Positive Psychology Intervention for Spanish-speaking Hispanic/Latino Adults at Risk for Cardiovascular Disease
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03221114 |
Recruitment Status : Unknown
Verified March 2019 by University of Illinois at Urbana-Champaign.
Recruitment status was: Recruiting
First Posted : July 18, 2017
Last Update Posted : March 20, 2019
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Uncontrolled Hypertension Cardiovascular Risk Factor | Behavioral: Positive Psychological Intervention | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 126 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Cluster-randomized control trial |
Masking: | Single (Outcomes Assessor) |
Masking Description: | Outcome assessors will be blind to intervention assignment and will only collect clinical data at baseline, 8-, and 12-weeks. |
Primary Purpose: | Treatment |
Official Title: | Positive Psychology Intervention for Spanish-speaking Hispanic/Latino Adults at Risk for Cardiovascular Disease |
Actual Study Start Date : | October 1, 2017 |
Estimated Primary Completion Date : | September 2020 |
Estimated Study Completion Date : | July 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: Positive Psychological Intervention
Our culturally-tailored Positive Psychology (PP) Intervention is a non-pharmacotherapy approach aimed at increasing positive emotional experiences by teaching individuals to engage in intentional activities known to increase psychological and emotional well-being through targeting of constructs such as optimism, gratitude, mindfulness/relaxation, and resilience.
|
Behavioral: Positive Psychological Intervention
Our culturally-tailored Positive Psychology Intervention is a non-pharmacotherapy approach aimed at increasing positive emotional experiences by teaching individuals to engage in intentional activities known to increase psychological and emotional well-being through targeting of constructs such as optimism, gratitude, mindfulness/relaxation, and resilience.
Other Name: Positive Affect Intervention |
No Intervention: Wait list control
Receipt after the active treatment group has completed the positive psychological intervention.
|
- Change from Baseline Ambulatory Blood Pressure at 8- and 12-weeks [ Time Frame: Baseline, 8-, and 12-weeks ]The device, Vitavue, consists of a wireless microcontroller that connects to a desktop computer running proprietary software when operated in real time connected mode. Alternatively, it can be operated in standalone unconnected mode by logging acquired data to an internal memory storage device. The device contains a number of sensors including ECG single channel amplifier, Multispectral Photodiode to record photo pulse plethysmograms, temperature sensor to measure skin temperature, and an accelerometer to record the level of activity.
- Center for Epidemiological Studies Depression Scale (CESD): Change from Baseline Depressive Symptoms at 8- and 12-weeks [ Time Frame: Baseline, 8-, and 12-weeks ]Center for Epidemiological Studies Depression-Scale
- Life Orientation Test-Revised (LOT-R): Change from Baseline Dispositional Optimism at 8- and 12-weeks [ Time Frame: Baseline, 8-, and 12-weeks ]Life Orientation Test-Revised
- General Well-being Schedule: Change in Baseline Emotional Vitality at 8- and 12-weeks [ Time Frame: Baseline, 8-, and 12-weeks ]General Well-being Schedule
- Life Engagement Test (LET): Change in Baseline Life engagement and Meaning at 8- and 12-weeks [ Time Frame: Baseline, 8-, and 12-weeks ]Life Engagement Test
- Physical Activity: Change in Hypertension-related Health Behavior(s) [ Time Frame: Baseline, 8-, and 12-weeks ]Physical Activity using Fitbit One
- Diet: Change in Hypertension-related Health Behavior(s) [ Time Frame: Baseline, 8-, and 12-weeks ]Diet using Scored Sodium Questionnaire
- Change in Heart Rate Variability [ Time Frame: Baseline, 8-, and 12-weeks ]Beat-to-beat interval
- Change in High-sensitivity C-Reactive Protein [ Time Frame: Baseline, 8-, and 12-weeks ]mg/L

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Hispanics/Latinos recruited from Catholic church sites in Chicago-land area
- aged ≥18
- fluent in English or Spanish with ≥8th grade education
- elevated 24-hour ambulatory blood pressure levels (systolic BP> 140 mmHg and >90 mmHg for diastolic BP).
Exclusion Criteria:
- Unavailable for study period; have cognitive impairment denoting dementia
- have severely reduced life expectancy
- are currently enrolled in psychotherapy or take prescribed antidepressants
- history or current diagnosis of bipolar disorder, dissociative disorder, psychosis, or substance abuse
- have severe depression.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03221114
Contact: Rosalba Hernandez, PhD | 217-300-1049 | rherna17@illinois.edu |
United States, Illinois | |
St. Pius V Parish | Recruiting |
Chicago, Illinois, United States, 60608 | |
Contact: Jose M Santiago 312-226-6161 |
Responsible Party: | University of Illinois at Urbana-Champaign |
ClinicalTrials.gov Identifier: | NCT03221114 |
Other Study ID Numbers: |
1K01HL130712-01A1 ( U.S. NIH Grant/Contract ) |
First Posted: | July 18, 2017 Key Record Dates |
Last Update Posted: | March 20, 2019 |
Last Verified: | March 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | We will make the data available to users only under a data-sharing agreement that provides for: (1) a commitment to use data only for research purposes and not to identify any individual participant; (2) a commitment to secure the data using appropriate technology; and (3) a commitment to destroy or return data after analyses are completed. If additional outputs result from this research that would be appropriate to share with a wider audience, we will work with the Research Data Service at the University Library to determine appropriate venues for archiving and sharing. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Hispanics/Latinos Underserved Population |
Cardiovascular Diseases |