NCT03223545

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P50-P75 for not_applicable hypertension

Timeline
Completed

Started May 2018

Typical duration for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 18, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 21, 2017

Completed
10 months until next milestone

Study Start

First participant enrolled

May 7, 2018

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 17, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 17, 2020

Completed
Last Updated

August 14, 2020

Status Verified

August 1, 2020

Enrollment Period

2.2 years

First QC Date

July 18, 2017

Last Update Submit

August 13, 2020

Conditions

HypertensionStressCardiovascular Diseases

Keywords

mindfulness-based cognitive therapyMeditation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Perceived stress

    3 Months

  • Measure of Depressive Symptoms using the PHQ-8

    3 Months

Study Arms (2)

Mindfulness-based cognitive therapy delivered by telephone

EXPERIMENTAL
Behavioral: MBCT-T

Usual Care (UC)

PLACEBO COMPARATOR
Behavioral: Usual Care

Interventions

MBCT-TBEHAVIORAL

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.

Mindfulness-based cognitive therapy delivered by telephone
Usual CareBEHAVIORAL

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".

Usual Care (UC)

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsBased on the study aims, the sample will be 100% female.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

HypertensionCardiovascular Diseases

Condition Hierarchy (Ancestors)

Vascular Diseases

Study Officials

  • Tanya Spruill, MD

    NYU Langone Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 18, 2017

First Posted

July 21, 2017

Study Start

May 7, 2018

Primary Completion

July 17, 2020

Study Completion

July 17, 2020

Last Updated

August 14, 2020

Record last verified: 2020-08

Locations

US(1)