Recruiting

Positive Psychology

Sponsor:

University of Illinois at Urbana-Champaign

Code:

NCT03221114

Conditions

Uncontrolled Hypertension

Cardiovascular Risk Factor

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Positive Psychological Intervention

Study Details

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

Study ID

NCT03221114

Start date

Oct 1, 2017

Status verified date

Mar, 2019

Completion date

Jul, 2021

Anticipated

Primary completion date

Sep, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

126 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

no intervention: Wait list control

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

Interventions

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.

Primary outcome measure

  • Change from Baseline Ambulatory Blood Pressure at 8- and 12-weeks [ Time Frame: Baseline, 8-, and 12-weeks ]

Central Contacts and Locations

Central contacts

Locations

St. Pius V Parish

Recruiting

Chicago, Illinois, United States, 60608

Contacts

Jose M Santiago

312-226-6161

More Information

Sponsor

University of Illinois at Urbana-Champaign

Last update posted

Mar 20, 2019

Last verified

Mar, 2019

Keywords

  • Hispanics/Latinos
  • Underserved Population

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Illinois at Urbana-Champaign on 2019-03-20.