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

NCT ID: NCT03892057

Last Updated: 2019-07-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-12
• Study Completion Date: 2021-06-30

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.

Detailed 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.

Conditions

Uncontrolled Hypertension; Cardiovascular Risk Factor

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Internet-based Positive Psychological Intervention

Intervention Type: BEHAVIORAL

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Positive Affect Intervention

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rosenfeld Heart Foundation Grant

UNKNOWN

Sponsor Role: collaborator

University of Illinois at Urbana-Champaign

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rosalba Hernandez, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Illinois at Urbana-Champaign

Locations

UI Health Pilsen Family Health Center Lower West

Chicago, Illinois, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Rosalba Hernandez, PhD

Role: CONTACT

rherna17@illinois.edu

217-300-1049

Facility Contacts

Maura Stefko-Woznika, MD

Role: primary

References

Hernandez R, Cohn M, Hernandez A, Daviglus M, Martinez L, Martinez A, Martinez I, Durazo-Arvizu R, Moskowitz J. A Web-Based Positive Psychological Intervention to Improve Blood Pressure Control in Spanish-Speaking Hispanic/Latino Adults With Uncontrolled Hypertension: Protocol and Design for the inverted exclamation markAlegrate! Randomized Controlled Trial. JMIR Res Protoc. 2020 Aug 4;9(8):e17721. doi: 10.2196/17721.

Reference Type: DERIVED

PMID: 32749224 (View on PubMed)

Other Identifiers

08776

Identifier Type: -

Identifier Source: org_study_id