Stress Management to Support Women's Health

Hypertension Clinical Trial

Official title:

Stress Management to Support Women's Health

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03223545
• Other study ID #: 17-00725
• Status: Completed
• Phase: N/A
• Start date: May 7, 2018
• Est. completion date: July 17, 2020

Study information

• Verified date: August 2020
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: July 17, 2020
• Est. primary completion date: July 17, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Hypertension
• Stress

Intervention

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.
• 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".

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Perceived stress	Items are rated on a 5-point scale, and higher total scores indicate greater perceived stress.	3 Months
Secondary	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