Stress Management to Support Women's Health

Completed · Not applicable

Conditions studied: Hypertension, Stress, Cardiovascular Diseases

In brief

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.

Key facts

Study ID

NCT03223545

Run by

NYU Langone Health

People needed

106

Starts

2018-05-07

Expected to finish

2020-07-17

Last updated by the study team

2020-08-14

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• New York University School of Medicine — New York, New York, United States

Full record on ClinicalTrials.gov

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