Stress Management to Support Women's Health



Status:Recruiting
Conditions:High Blood Pressure (Hypertension), Peripheral Vascular Disease
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:6/9/2018
Start Date:May 7, 2018
End Date:July 2019
Contact:Mallory Rutigliano
Email:Mallory.Rutigliano@nyumc.org
Phone:646 501 2619

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The purpose of this study is to evaluate a mindfulness-based cognitive therapy intervention
delivered over the phone (MBCT-T) for women with prehypertension. MBCT-T is an evidence-based
program that teaches meditation practices and cognitive strategies to reduce stress and
negative emotions. It targets psychosocial risk factors that disproportionately affect women,
including rumination (i.e., negative thinking) and low social support. Investigators plan to
translate the established MBCT-T program into Spanish, conduct focus groups to inform
cultural adaptations that may be needed for Latina women, and run a pilot randomized
controlled trial to test the feasibility, acceptability and effects of MBCT-T on blood
pressure and perceived stress in diverse women with prehypertension.

Chronic stress is associated with the development of hypertension and cardiovascular disease.
Reducing stress may be a useful prevention strategy for people at elevated risk of
hypertension, including those with prehypertension. Women report different types of stress
than men and may need tailored stress management programs.

Inclusion Criteria:

- Female

- English- or Spanish-speaking

- A current patient of NYU/Bellevue Hospital Center (BHC) for the NYU study site or San
Ysidro Health Center (SYHC) for the UCSD study site

- BP measurement in prehypertensive range (SBP 120-139 mmHg or DBP 80-89 mmHg) recorded
in EHR within past 6 months AND BP in prehypertensive range at screening

- Willing to provide informed consent and comply with all aspects of the protocol

- Willing to be audio-taped

Exclusion Criteria:

- Current use of antihypertensive medication

- Clinically significant depressive symptoms (PHQ-8 ≥10)

- Significant cognitive impairment, in the EHR or apparent during screening

- History of current diagnosis of schizophrenia or other psychotic disorders

- Current participation in another clinical trial
We found this trial at
1
site
550 1st Ave
New York, New York 10016
(212) 263-7300
Principal Investigator: Tanya Spruill, MD
Phone: 646-501-2619
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