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Stress/Emotion Management for High Blood Pressure (OUR-Project Trial)

N/A
Waitlist Available
Led By Kathy D Wright, PhD, RN
Research Sponsored by Ohio State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Female sex
Be older than 18 years old
Must not have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 3 months
Awards & highlights
No Placebo-Only Group

Summary

This trial will test a synchronous web-based version of Enhanced Co-Created Health Education InterventioN (eCo-CHIN) to help Black women with hypertension manage stress and emotional well-being in a social-distancing society.

Who is the study for?
This trial is for Black/African American women who have high blood pressure, can speak English, and have access to a smartphone or computer with internet. It's not for those with resistant hypertension (blood pressure too high despite using three different meds including a diuretic) or without internet access.
What is being tested?
The study tests an online stress and emotion management program called eCo-CHIN, designed specifically for Black women managing hypertension during the Covid-19 pandemic. It includes sessions on resilience and self-care in times of social distancing.
What are the potential side effects?
Since this intervention involves stress management techniques rather than medication, there are no direct medical side effects. However, participants may experience emotional discomfort while discussing personal experiences related to stress.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am female.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My high blood pressure isn't controlled despite taking three different blood pressure medicines, including a water pill.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change from baseline at 3 months blood pressure.
Change from baseline at 3 months waist circumference.
Change from baseline at 3 months weight.
+2 more
Secondary study objectives
Change from baseline dietary approaches to stop hypertension knowledge at 3 months.
Change from baseline emotional regulation at 3 months.
Change from baseline resilience at 3 months.
+2 more
Other study objectives
Explore the feasibility of collecting cognitive performance data (processing speed, attention, and executive function) via teleconference.

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Stress and emotion Management for Black/African AmericExperimental Treatment1 Intervention
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.

Find a Location

Who is running the clinical trial?

Ohio State UniversityLead Sponsor
866 Previous Clinical Trials
655,127 Total Patients Enrolled
Kathy D Wright, PhD, RNPrincipal InvestigatorAssistant Professor

Media Library

Stress and emotion management Clinical Trial Eligibility Overview. Trial Name: NCT04526145 — N/A
Stress Research Study Groups: Stress and emotion Management for Black/African Americ
Stress Clinical Trial 2023: Stress and emotion management Highlights & Side Effects. Trial Name: NCT04526145 — N/A
Stress and emotion management 2023 Treatment Timeline for Medical Study. Trial Name: NCT04526145 — N/A
~0 spots leftby Nov 2024