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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03221114
Recruitment Status : Recruiting
First Posted : July 18, 2017
Last Update Posted : March 20, 2019
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
University of Illinois at Urbana-Champaign

Study Description
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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.

Condition or disease Intervention/treatment Phase
Uncontrolled Hypertension Cardiovascular Risk Factor Behavioral: Positive Psychological Intervention Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Cluster-randomized control trial
Masking: Single (Outcomes Assessor)
Masking Description: Outcome assessors will be blind to intervention assignment and will only collect clinical data at baseline, 8-, and 12-weeks.
Primary Purpose: Treatment
Official Title: Positive Psychology Intervention for Spanish-speaking Hispanic/Latino Adults at Risk for Cardiovascular Disease
Actual Study Start Date : October 1, 2017
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: Positive Affect Intervention
No Intervention: Wait list control
Receipt after the active treatment group has completed the positive psychological intervention.


Outcome Measures
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Primary Outcome Measures :
  1. Change from Baseline Ambulatory Blood Pressure at 8- and 12-weeks [ Time Frame: Baseline, 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.


Secondary Outcome Measures :
  1. Center for Epidemiological Studies Depression Scale (CESD): Change from Baseline Depressive Symptoms at 8- and 12-weeks [ Time Frame: Baseline, 8-, and 12-weeks ]
    Center for Epidemiological Studies Depression-Scale

  2. Life Orientation Test-Revised (LOT-R): Change from Baseline Dispositional Optimism at 8- and 12-weeks [ Time Frame: Baseline, 8-, and 12-weeks ]
    Life Orientation Test-Revised

  3. General Well-being Schedule: Change in Baseline Emotional Vitality at 8- and 12-weeks [ Time Frame: Baseline, 8-, and 12-weeks ]
    General Well-being Schedule

  4. Life Engagement Test (LET): Change in Baseline Life engagement and Meaning at 8- and 12-weeks [ Time Frame: Baseline, 8-, and 12-weeks ]
    Life Engagement Test


Other Outcome Measures:
  1. Physical Activity: Change in Hypertension-related Health Behavior(s) [ Time Frame: Baseline, 8-, and 12-weeks ]
    Physical Activity using Fitbit One

  2. Diet: Change in Hypertension-related Health Behavior(s) [ Time Frame: Baseline, 8-, and 12-weeks ]
    Diet using Scored Sodium Questionnaire

  3. Change in Heart Rate Variability [ Time Frame: Baseline, 8-, and 12-weeks ]
    Beat-to-beat interval

  4. Change in High-sensitivity C-Reactive Protein [ Time Frame: Baseline, 8-, and 12-weeks ]
    mg/L


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03221114


Contacts
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Contact: Rosalba Hernandez, PhD 217-300-1049 rherna17@illinois.edu

Locations
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United States, Illinois
St. Pius V Parish Recruiting
Chicago, Illinois, United States, 60608
Contact: Jose M Santiago    312-226-6161      
Sponsors and Collaborators
University of Illinois at Urbana-Champaign
National Heart, Lung, and Blood Institute (NHLBI)
More Information
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Responsible Party: University of Illinois at Urbana-Champaign
ClinicalTrials.gov Identifier: NCT03221114    
Other Study ID Numbers: 1K01HL130712-01A1 ( U.S. NIH Grant/Contract )
First Posted: July 18, 2017    Key Record Dates
Last Update Posted: March 20, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Illinois at Urbana-Champaign:
Hispanics/Latinos
Underserved Population
Additional relevant MeSH terms:
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Cardiovascular Diseases