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

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.

Study Overview

• Status: Unknown
• Conditions: Cardiovascular Risk Factor; Uncontrolled Hypertension
• Intervention / Treatment: Behavioral: Positive Psychological Intervention

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 126
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60608
      • Recruiting
      • St. Pius V Parish
      • Contact: Jose M Santiago; Phone Number: 312-226-6161

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: Positive Affect Intervention
No Intervention: Wait list control; Receipt after the active treatment group has completed the positive psychological intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
General Well-being Schedule: Change in Baseline Emotional Vitality at 8- and 12-weeks	General Well-being Schedule	Baseline, 8-, and 12-weeks
Life Engagement Test (LET): Change in Baseline Life engagement and Meaning at 8- and 12-weeks	Life Engagement Test	Baseline, 8-, and 12-weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical Activity: Change in Hypertension-related Health Behavior(s)	Physical Activity using Fitbit One	Baseline, 8-, and 12-weeks
Diet: Change in Hypertension-related Health Behavior(s)	Diet using Scored Sodium Questionnaire	Baseline, 8-, and 12-weeks
Change in Heart Rate Variability	Beat-to-beat interval	Baseline, 8-, and 12-weeks
Change in High-sensitivity C-Reactive Protein	mg/L	Baseline, 8-, and 12-weeks

Collaborators and Investigators

• Sponsor: University of Illinois at Urbana-Champaign
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2017
• Primary Completion (Anticipated): September 1, 2020
• Study Completion (Anticipated): July 1, 2021

Study Registration Dates

• First Submitted: June 14, 2017
• First Submitted That Met QC Criteria: July 13, 2017
• First Posted (Actual): July 18, 2017

Study Record Updates

• Last Update Posted (Actual): March 20, 2019
• Last Update Submitted That Met QC Criteria: March 18, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Hispanics/Latinos; Underserved Population
• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: 1K01HL130712-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No