Stress Management to Support Women's Health

• ClinicalTrials.gov Identifier: NCT03223545
• Recruitment Status: Completed
• First Posted: July 21, 2017
• Last Update Posted: August 14, 2020
• Sponsor: NYU Langone Health
• Information provided by (Responsible Party): NYU Langone Health

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Hypertension; Stress; Cardiovascular Diseases	Behavioral: MBCT-T; Behavioral: Usual Care	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 106 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Stress Management to Support Women's Health
• Actual Study Start Date: May 7, 2018
• Actual Primary Completion Date: July 17, 2020
• Actual Study Completion Date: July 17, 2020

Arms and Interventions

Arm	Intervention/treatment
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.
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".

Outcome Measures

Primary Outcome Measures :

1. Blood pressure [ Time Frame: 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 :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Based on the study aims, the sample will be 100% female.
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, New York

New York University School of Medicine

New York, New York, United States, 10016

Sponsors and Collaborators

NYU Langone Health

Investigators

• Principal Investigator: Tanya Spruill, MD; NYU Langone Health

More Information

• Responsible Party: NYU Langone Health
• ClinicalTrials.gov Identifier: NCT03223545
• Other Study ID Numbers: 17-00725
• First Posted: July 21, 2017
• Last Update Posted: August 14, 2020
• Last Verified: August 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by NYU Langone Health:

mindfulness-based cognitive therapy; Meditation

Additional relevant MeSH terms:

Cardiovascular Diseases