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

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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

Tracking Information
First Submitted Date  ICMJE June 14, 2017
First Posted Date  ICMJE July 18, 2017
Last Update Posted Date March 20, 2019
Actual Study Start Date  ICMJE October 1, 2017
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 13, 2017)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 13, 2017)
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: July 13, 2017)
  • Physical Activity: Change in Hypertension-related Health Behavior(s) [ Time Frame: Baseline, 8-, and 12-weeks ]
    Physical Activity using Fitbit One
  • Diet: Change in Hypertension-related Health Behavior(s) [ Time Frame: Baseline, 8-, and 12-weeks ]
    Diet using Scored Sodium Questionnaire
  • Change in Heart Rate Variability [ Time Frame: Baseline, 8-, and 12-weeks ]
    Beat-to-beat interval
  • Change in High-sensitivity C-Reactive Protein [ Time Frame: Baseline, 8-, and 12-weeks ]
    mg/L
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Positive Psychology Intervention for Spanish-speaking Hispanic/Latino Adults at Risk for Cardiovascular Disease
Official Title  ICMJE Positive Psychology Intervention for Spanish-speaking Hispanic/Latino Adults at Risk for Cardiovascular Disease
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Uncontrolled Hypertension
  • Cardiovascular Risk Factor
Intervention  ICMJE 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
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Positive Psychological Intervention
  • No Intervention: Wait list control
    Receipt after the active treatment group has completed the positive psychological intervention.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 13, 2017)
126
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2021
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Rosalba Hernandez, PhD 217-300-1049 rherna17@illinois.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03221114
Other Study ID Numbers  ICMJE 1K01HL130712-01A1( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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.
Responsible Party University of Illinois at Urbana-Champaign
Study Sponsor  ICMJE University of Illinois at Urbana-Champaign
Collaborators  ICMJE National Heart, Lung, and Blood Institute (NHLBI)
Investigators  ICMJE Not Provided
PRS Account University of Illinois at Urbana-Champaign
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP