Positive Psychology Intervention for Spanish-speaking Hispanic/Latino Adults at Risk for Cardiovascular Disease

Cardiovascular Risk Factor Clinical Trial

Official title:

Positive Psychology Intervention for Spanish-speaking Hispanic/Latino Adults at Risk for Cardiovascular Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03221114
• Other study ID #: 1K01HL130712-01A1
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2017
• Est. completion date: July 2021

Study information

• Verified date: March 2019
• Source: University of Illinois at Urbana-Champaign
• Contact: Rosalba Hernandez, PhD
• Phone: 217-300-1049
• Email: rherna17[@]illinois.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The largest epidemiologic study of Hispanic/Latino participants thus far, i.e., the Hispanic Community Health Study/Study of Latinos (HCHS/SOL) documented that 80% of men and 71% of women have at least one major cardiovascular disease (CVD) risk factor. The American Heart Association emphasizes that current CVD prevention efforts are sparse and ineffectual in minority populations and acknowledges the need for new and more effective disease prevention strategies. This observational study and pilot cluster-randomized clinical trial seeks to implement and evaluate a novel 8-week Positive Psychology (PP) Intervention (compared to an attention control condition) in Hispanic/Latino adults with uncontrolled hypertension, i.e., elevated 24-hour ambulatory blood pressure, with primary interest in testing efficacy for clinically meaningful improvements in cardiovascular function.

Description:

The study features piloting of a cluster-randomized trial to determine whether a positive psychology (PP) intervention is associated with greater improvements in blood pressure compared to an attention control condition. The pilot trial additionally evaluates the efficacy of the PP intervention with respect to psychological well-being, hypertension-related health behaviors, autonomic cardiac control, and high-sensitivity C-reactive protein. Serum blood assays will facilitate exploration of mechanistic indicators linking psychological well-being to cardiac functioning.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 126
• Est. completion date: July 2021
• Est. primary completion date: September 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Cardiovascular Risk Factor
• Hypertension
• Uncontrolled Hypertension

Intervention

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.

Locations

Country	Name	City	State
United States	St. Pius V Parish	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Illinois at Urbana-Champaign	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Physical Activity: Change in Hypertension-related Health Behavior(s)	Physical Activity using Fitbit One	Baseline, 8-, and 12-weeks
Other	Diet: Change in Hypertension-related Health Behavior(s)	Diet using Scored Sodium Questionnaire	Baseline, 8-, and 12-weeks
Other	Change in Heart Rate Variability	Beat-to-beat interval	Baseline, 8-, and 12-weeks
Other	Change in High-sensitivity C-Reactive Protein	mg/L	Baseline, 8-, and 12-weeks
Primary	Change from Baseline Ambulatory Blood Pressure at 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.	Baseline, 8-, and 12-weeks
Secondary	Center for Epidemiological Studies Depression Scale (CESD): Change from Baseline Depressive Symptoms at 8- and 12-weeks	Center for Epidemiological Studies Depression-Scale	Baseline, 8-, and 12-weeks
Secondary	Life Orientation Test-Revised (LOT-R): Change from Baseline Dispositional Optimism at 8- and 12-weeks	Life Orientation Test-Revised	Baseline, 8-, and 12-weeks
Secondary	General Well-being Schedule: Change in Baseline Emotional Vitality at 8- and 12-weeks	General Well-being Schedule	Baseline, 8-, and 12-weeks
Secondary	Life Engagement Test (LET): Change in Baseline Life engagement and Meaning at 8- and 12-weeks	Life Engagement Test	Baseline, 8-, and 12-weeks