Recruiting

Positive Psychological Intervention

Sponsor:

University of Illinois at Urbana-Champaign

Code:

NCT03892057

Conditions

Uncontrolled Hypertension

Cardiovascular Risk Factor

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Internet-based 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 proof-of-concept study and pilot randomized clinical trial seeks to implement and evaluate a novel internet-based 5-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

NCT03892057

Start date

Apr 12, 2019

Status verified date

Jul, 2019

Completion date

Jun, 2021

Anticipated

Primary completion date

Jan, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Hispanics/Latinos recruited from UI Health Pilsen Family Health Center Lower West
  • Aged ≥18
  • Fluent in English or Spanish with ≥8th grade education
  • Elevated sitting blood pressure (≥140/90)
  • Ability to read and understand the informed consent
  • Ability to access internet from home or in public setting (note, tablet PCs will be made available to all enrolled participants at no charge), and
  • Self-reported comfort in with handling of a table computer and website navigation.

Exclusion Criteria:

  • Cognitive impairment denoting dementia (assessed using the Short Portable Status Questionnaire-See Appendix E)
  • Severely reduced life expectancy (e.g., self-reported diagnosis of metastatic cancer, congestive heart failure, or end-stage kidney disease)
  • Self-reported diagnosis of sickle cell disease
  • Skin damage or rash in the upper arm region where ambulatory blood pressure monitor is to be placed
  • Currently enrolled in psychotherapy, and
  • Self-reported history or current diagnosis of bipolar disorder, dissociative disorder, psychosis, or substance abuse; or have severe depression.

Study Design

Enrollment

70 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Internet-based Positive Psychological Intervention

The investigator's culturally-tailored internet-based 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: Attention Control Group

Participants will complete computerized surveys to document the frequency of positive and negative emotions experienced in daily life. The attention control group will be given the option to access our positive psychological intervention and associated content via the web at the conclusion of the 12-week data collection phase.

Interventions

Internet-based Positive Psychological Intervention

The investigator's culturally-tailored internet-based 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, e.g., mindfulness/meditation. The current 5-week Internet-based intervention will be delivered via a secure website which participants will access at home (or in a public setting with Wi-Fi) using an assigned username and password. The on-line program includes didactic material and "home practice" with participants logging into the website 3-4 times per week for 15 to 20 minute sessions. In addition to weekly on-line instruction, participants are assigned homework as a means of incorporating skills learned into their day-to-day activities.

Primary outcome measure

  • Change from Baseline Ambulatory Blood Pressure at 5- and 12-weeks [ Time Frame: Baseline, 5-, and 12-weeks ]

Central Contacts and Locations

Central contacts

Rosalba Hernandez, PhD

217-300-1049rherna17@illinois.edu

Locations

UI Health Pilsen Family Health Center Lower West

Recruiting

Chicago, Illinois, United States, 60608

More Information

Sponsor

University of Illinois at Urbana-Champaign

Last update posted

Jul 5, 2019

Last verified

Jul, 2019

Keywords

  • Hispanics/Latinos
  • Underserved Population
  • Internet-based

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 2019-07-05.