OUR Stress/ Emotion Management for Black/African American Women With Hypertension

NCT ID: NCT04526145

Last Updated: 2025-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-01
• Study Completion Date: 2024-12-31

Brief Summary

Covid-19 is an additional stressor Black women have to deal with that may interfere with hypertension self-care management. Social connectedness is a source of resilience for Black women to promote mental and physical health. Unfortunately, in the face of the Covid-19 pandemic, social distancing is a challenge further isolating Black women from their networks. How is social connectedness to manage stress and emotional well-being in a social-distancing society for Black women with hypertension? The research team proposed a synchronous web-based version of Enhanced Co-Created Health Education InterventioN (eCo-CHIN) that build the success and best practices derived from the original intervention. A Covid-19 session will be included as a way of helping Black women to maintain resilience and self-care during stressful times. The eCo-CHIN intervention is innovative and timely because the research team are using a synchronous platform preparing Black women on how to deal with Covid-19 while taking care of self. The primary investigator for this pilot study (Dr. Wright) is a Black Early Stage Investigator and former KL2 (career development) awardee. The interdisciplinary research team has the expertise and resources to deliver this Enhanced Co-CHIN intervention.

Detailed Description

The rationale for the study is that the adherence to healthy self-care behaviors reduces poor nutrition, altered sleep, sedentary behavior, psychosocial stress, and emotional dysregulation, thereby reducing negative impacts on the brain, since all these factors contribute to neural inflammation and increased BP. Health-promoting self-care behaviors have the known short-term effect of enhanced cognitive function (processing speed, attention, and executive function) through the use of The Repeatable Neuropsychiatric Battery (RBANS) which is also an innovative component of OUR Project. Thirty middle-aged Black women (45-65 years old) with a self-reported diagnosis of hypertension will be enrolled. The development of this group-delivered intervention will be an iterative process, and the research team will use this pilot data to submit an R21 for a 12-week intervention through the National Institutes on Aging.

Conditions

Stress, Psychological

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Stress and emotion Management for Black/African Americ

Four weekly sessions delivered in a group format via Zoom teleconference. The following topics are listed in the workbook: Planning Your Information Diet; My Spheres of Influence Worksheet; Practical Wisdom for Tolerating Uncertainty; Reducing Anxiety With Thought Challenging; Reducing Anxiety Through Distraction Activities; Starting a Planning Practice; Starting a Daily Gratitude Practice; Starting a Daily Breathing Practice; Improving the Quality of Your Social Connections; Developing a Regular Exercise Routine; and Creating Your Stress-Resilience Action Plan. Each session will begin with a 15-30 minute check in on what went well, challenges, and Coronavirus Anxiety workbook. The Coronavirus Anxiety Workbook topics are complementary and the sessions will tie together the themes of comprehensive stress and emotional management through blood pressure knowledge/self-monitoring, diet, interpersonal communication skills building, and sleep hygiene.

Group Type: EXPERIMENTAL

Stress and emotion management

Intervention Type: BEHAVIORAL

Group intervention led by a nurse and dietitian to address stress, emotion management and healthy lifestyle for African American women with hypertension. The weekly sessions will include:how to manage stress during Covid-19, taking blood pressure, interpersonal relationships skills, mindful awareness, restful sleep, physical activity, and healthy eating.

Interventions

Stress and emotion management

Group intervention led by a nurse and dietitian to address stress, emotion management and healthy lifestyle for African American women with hypertension. The weekly sessions will include:how to manage stress during Covid-19, taking blood pressure, interpersonal relationships skills, mindful awareness, restful sleep, physical activity, and healthy eating.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• English speaking,
• self-identification as Black/African America
• diagnosis of hypertension (treated with medications and or lifestyle management)
• female sex
• access to a smart phone or a computer capable of connecting to the Internet

Exclusion Criteria

• no access to computer with internet Smart phone
• diagnosis of resistant hypertension defined as blood pressure that remains above goal despite concurrent use of three antihypertensive agents of different classes, one of which should be a diuretic/water pill.

• Minimum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Ohio State University

OTHER

Sponsor Role: lead

Responsible Party

Kathy D. Wright

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kathy D Wright, PhD, RN

Role: PRINCIPAL_INVESTIGATOR

Assistant Professor

Locations

The Ohio State University

Columbus, Ohio, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

2020B0182

Identifier Type: -

Identifier Source: org_study_id