Clinical trial NCT03221114: Positive Psychology Intervention for Spanish-speaking Hispanic/Latino Adults at Risk for Cardiovascular Disease
Official title: Positive Psychology Intervention for Spanish-speaking Hispanic/Latino Adults at Risk for Cardiovascular Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Uncontrolled Hypertension
Cardiovascular Risk Factor
Keywords: Hispanics/Latinos
Underserved Population
Lead sponsor: University of Illinois at Urbana-Champaign
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2017-07-18
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster-randomized control trial
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from Baseline Ambulatory Blood Pressure at 8- and 12-weeks
timeFrame: Baseline, 8-, and 12-weeks
Secondary outcomes:
measure: Center for Epidemiological Studies Depression Scale (CESD): Change from Baseline Depressive Symptoms at 8- and 12-weeks
timeFrame: Baseline, 8-, and 12-weeks
measure: Life Orientation Test-Revised (LOT-R): Change from Baseline Dispositional Optimism at 8- and 12-weeks
timeFrame: Baseline, 8-, and 12-weeks
measure: General Well-being Schedule: Change in Baseline Emotional Vitality at 8- and 12-weeks
timeFrame: Baseline, 8-, and 12-weeks
measure: Life Engagement Test (LET): Change in Baseline Life engagement and Meaning at 8- and 12-weeks
timeFrame: Baseline, 8-, and 12-weeks
Other outcomes:
measure: Physical Activity: Change in Hypertension-related Health Behavior(s)
timeFrame: Baseline, 8-, and 12-weeks
measure: Diet: Change in Hypertension-related Health Behavior(s)
timeFrame: Baseline, 8-, and 12-weeks
measure: Change in Heart Rate Variability
timeFrame: Baseline, 8-, and 12-weeks
measure: Change in High-sensitivity C-Reactive Protein
timeFrame: Baseline, 8-, and 12-weeks
Locations:
city: Chicago
country: United States
facility: St. Pius V Parish
state: Illinois
Study officials:
References: