Stress Management to Support Women's Health

Not Applicable

Completed

• Conditions: Cardiovascular Diseases; Stress; Hypertension
• Interventions: Behavioral: MBCT-T; Behavioral: Usual Care

• Registration Number: NCT03223545
• Lead Sponsor: NYU Langone Health

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2017-07-18
• Study First Submitted QC: 2017-07-18
• Study First Posted: 2017-07-21
• Study Start: 2018-05-07
• Primary Completion: 2020-07-17
• Study Completion: 2020-07-17
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-13
• Last Update Posted: 2020-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 106

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mindfulness-based cognitive therapy delivered by telephone	MBCT-T	-
Usual Care (UC)	Usual Care	-

Primary Outcome Measures

Name	Time	Method
Blood pressure	3 Months	The mean of three BP readings taken by a trained RA with an automated and validated BP monitor (Microlife WatchBP Office) will be recorded at each visit. Participants will be seated comfortably for 5 minutes with feet flat on the ground prior to measurements. The device will take three readings at 2-minute intervals.

Secondary Outcome Measures

Name	Time	Method
Perceived stress	3 Months	Items are rated on a 5-point scale, and higher total scores indicate greater perceived stress.
Measure of Depressive Symptoms using the PHQ-8	3 Months	The PHQ-8 is a validated measure of depressive symptoms during the prior two weeks based on DSM-IV diagnostic criteria for major depression. The PHQ-8 will be completed at screening; patients with scores ≥10, suggestive of clinically significant depressive symptoms, will be excluded and provided with treatment referrals.

Trial Locations

Locations (1)

New York University School of Medicine; 🇺🇸 New York, New York, United States