Internet-based Positive Psychological Intervention for Hispanic/Latino Adult With Hypertension in a Primary Care Setting

University of Illinois at Urbana-Champaign

Status: Unknown

Conditions: Uncontrolled Hypertension; Cardiovascular Risk Factor

Treatments: Behavioral: Internet-based Positive Psychological Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT03892057

08776

Details and patient eligibility

About

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.

Full description

The study features piloting of a randomized trial to determine whether an internet-based 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 internet-based 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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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70 participants in 2 patient groups

Internet-based Positive Psychological Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Internet-based Positive Psychological Intervention

Attention Control Group

No Intervention group

Description:

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.