Behavioural Treatment of Hypertension

September 16, 2011 updated by: University of British Columbia
The objective of the study is to determine whether psychological therapy (self-help or individualized intense stress management) is different than a single drug treatment in terms of their effectiveness for lowering blood pressure.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • British Columbia
      • Vancouver, British Columbia, Canada, V6T 2B5
        • UBC Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • must be at least 19 years of age
  • subjects can be male or female
  • subjects must have an average resting blood pressure of >140 systolic pressure an/ or >90 diastolic pressure off anti-hypertensive medication

Exclusion Criteria:

  • must not be on more than 2 blood pressure lowering drugs
  • must not have known or suspected of having secondary hypertension on initial examination
  • must not be pregnant or anticipating pregnancy during study period
  • must not have history of allergy, hypersensitivity or intolerance to diuretics
  • must not have medical condition that may result in an unacceptable risk of complications due to uncontrolled hypertension during time period of study
  • must not have average resting BP readings that exceed 190 systolic, or 115 diastolic, or have two consecutive readings of 180 systolic or 110 diastolic

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Day time ambulatory BP
Time Frame: See description
See description

Secondary Outcome Measures

Outcome Measure
Time Frame
24 hour ambulatory BP, and office resting BP
Time Frame: See description
See description

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Wolfgang Linden, PhD, University of British Columbia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2001

Primary Completion (Actual)

June 1, 2006

Study Completion (Actual)

June 1, 2006

Study Registration Dates

First Submitted

October 31, 2005

First Submitted That Met QC Criteria

November 1, 2005

First Posted (Estimate)

November 2, 2005

Study Record Updates

Last Update Posted (Estimate)

September 19, 2011

Last Update Submitted That Met QC Criteria

September 16, 2011

Last Verified

September 1, 2011

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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