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Mindfulness Training for Pregnancy-Related Hypertension

N/A
Recruiting
Led By Margaret H Bublitz
Research Sponsored by Lifespan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Must not have
Current severe depression or psychosis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up before and after the intervention, approximately 3 months
Awards & highlights
No Placebo-Only Group

Summary

This trial will test whether a mindfulness intervention can help prevent hypertensive disorders of pregnancy, which are a leading cause of maternal morbidity and mortality. The intervention will be delivered via phone, and participants will be asked to wear a wrist-worn biosensor.

Who is the study for?
This trial is for English-speaking pregnant women under 20 weeks' gestation, with blood pressure below 140/90, and at moderate to high risk for hypertensive disorders. It's not for those with multiple pregnancies, severe depression or psychosis, or who regularly practice mind-body activities like yoga or meditation.
What is being tested?
The study tests if mindfulness training can prevent hypertension during pregnancy without medication. Participants will either receive an 8-week phone-delivered mindfulness intervention or usual care. The effects on maternal blood pressure and stress-related parameters will be measured using surveys and biosensors.
What are the potential side effects?
Mindfulness training is generally considered safe but may include temporary increases in distress as individuals become more aware of their experiences. Physical side effects are rare but could include mild discomfort from wearing a wrist-worn biosensor.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am currently experiencing severe depression or psychosis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~before and after the intervention, approximately 3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and before and after the intervention, approximately 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
Perceived stress and mood responses to momentary stress
Secondary study objectives
Perceived and received support in response to momentary stress

Awards & Highlights

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

Trial Design

2Treatment groups
Experimental Treatment
Group I: Treatment as usualExperimental Treatment1 Intervention
Prenatal care
Group II: Mindfulness trainingExperimental Treatment1 Intervention
Phone-delivered mindfulness training
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mindfulness training
2005
Completed Phase 3
~1920

Find a Location

Who is running the clinical trial?

LifespanLead Sponsor
40 Previous Clinical Trials
40,922 Total Patients Enrolled
2 Trials studying Hypertension
34 Patients Enrolled for Hypertension
Margaret H BublitzPrincipal InvestigatorThe Miriam Hospital

Media Library

Mindfulness training Clinical Trial Eligibility Overview. Trial Name: NCT04626245 — N/A
Hypertension Research Study Groups: Mindfulness training, Treatment as usual
Hypertension Clinical Trial 2023: Mindfulness training Highlights & Side Effects. Trial Name: NCT04626245 — N/A
Mindfulness training 2023 Treatment Timeline for Medical Study. Trial Name: NCT04626245 — N/A
~56 spots leftby Jun 2026
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