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

NCT03221114 | Unknown

• 1 other identifier: 1K01HL130712-01A1
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Uncontrolled Hypertension; Cardiovascular Risk Factor

Keywords

Hispanics/Latinos; Underserved Population

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Center for Epidemiological Studies Depression Scale (CESD): Change from Baseline Depressive Symptoms at 8- and 12-weeks

  Baseline, 8-, and 12-weeks

• Life Orientation Test-Revised (LOT-R): Change from Baseline Dispositional Optimism at 8- and 12-weeks

  Baseline, 8-, and 12-weeks

• General Well-being Schedule: Change in Baseline Emotional Vitality at 8- and 12-weeks

  Baseline, 8-, and 12-weeks

• Life Engagement Test (LET): Change in Baseline Life engagement and Meaning at 8- and 12-weeks

  Baseline, 8-, and 12-weeks

Other Outcomes (4)

• Physical Activity: Change in Hypertension-related Health Behavior(s)

  Baseline, 8-, and 12-weeks

• Diet: Change in Hypertension-related Health Behavior(s)

  Baseline, 8-, and 12-weeks

• Change in Heart Rate Variability

  Baseline, 8-, and 12-weeks

Study Arms (2)

Positive Psychological Intervention

EXPERIMENTAL

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

Wait list control

NO INTERVENTION

Receipt after the active treatment group has completed the positive psychological intervention.

Interventions

Positive Psychological Intervention BEHAVIORAL

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.

Also known as: Positive Affect Intervention

Positive Psychological Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

St. Pius V Parish

Chicago, Illinois, 60608, United States

RECRUITING

Central Study Contacts

Rosalba Hernandez, PhD

CONTACT

217-300-1049; rherna17@illinois.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors will be blind to intervention assignment and will only collect clinical data at baseline, 8-, and 12-weeks.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cluster-randomized control trial

Study Record Dates

• First Submitted: June 14, 2017
• First Posted: July 18, 2017
• Study Start: October 1, 2017
• Primary Completion: September 1, 2020
• Study Completion: July 1, 2021
• Last Updated: March 20, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will share

Locations

US (1)