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

University of Illinois at Urbana-Champaign

Status: Unknown

Conditions: Uncontrolled Hypertension; Cardiovascular Risk Factor

Treatments: Behavioral: Positive Psychological Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03221114

1K01HL130712-01A1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 126 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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126 participants in 2 patient groups

Positive Psychological Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Positive Psychological Intervention

Wait list control

No Intervention group

Description:

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