Stress Management to Support Women's Health

NYU Langone Health

Status: Completed

Conditions: Hypertension; Cardiovascular Diseases; Stress

Treatments: Behavioral: Usual Care; Behavioral: MBCT-T

Study type: Interventional

Funder types: Other

Identifiers

NCT03223545

17-00725

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 106 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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106 participants in 2 patient groups, including a placebo group

Mindfulness-based cognitive therapy delivered by telephone

Experimental group

Treatment:

Behavioral: MBCT-T

Usual Care (UC)

Placebo Comparator group

Treatment:

Behavioral: Usual Care