Stress Management to Support Women's Health

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases; Hypertension; Stress
• Intervention / Treatment: Behavioral: MBCT-T; Behavioral: Usual Care

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 Type: Interventional
• Enrollment (Actual): 106
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • New York University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Usual Care (UC)	Behavioral: Usual Care; Treatment guidelines recommend counseling patients with prehypertension on the importance of lifestyle modification to reduce BP. Because of variability in counseling across primary care practices, the study team will provide all participants with NHLBI print educational materials to ensure exposure to lifestyle recommendations: "Your Guide to Lowering Blood Pressure"; and "Facts about the DASH Eating Plan".
Experimental: Mindfulness-based cognitive therapy delivered by telephone	Behavioral: MBCT-T; This 8-week program combines mindfulness training with cognitive therapy and is delivered to small groups of patients by telephone using a conference line. Each weekly session is 1 hour long and is comprised of a check-in period, teaching on the week's topic, group discussion, a skill-building exercise, and a home-based practice assignment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood pressure	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.	3 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perceived stress	Items are rated on a 5-point scale, and higher total scores indicate greater perceived stress.	3 Months
Measure of Depressive Symptoms using the PHQ-8	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.	3 Months

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Tanya Spruill, MD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): May 7, 2018
• Primary Completion (Actual): July 17, 2020
• Study Completion (Actual): July 17, 2020

Study Registration Dates

• First Submitted: July 18, 2017
• First Submitted That Met QC Criteria: July 18, 2017
• First Posted (Actual): July 21, 2017

Study Record Updates

• Last Update Posted (Actual): August 14, 2020
• Last Update Submitted That Met QC Criteria: August 13, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: Meditation; mindfulness-based cognitive therapy
• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: 17-00725

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No