Identifying Therapeutic Factors in an 8-Week (30 Hour) Mindfulness-Based Stress Reduction (MBSR) Program (mbsr)

May 13, 2012 updated by: Dr. Katalin Margittai, North York General Hospital
Since it's introduction in 1979 at the University of Massachusetts Medical Center by Dr. Jon Kabat-Zinn, Mindfulness-Based Stress Reduction (MBSR) has become a respected adjunct to conventional treatment for patients suffering from many diverse chronic ailments. Three decades of research have documented it's benefits, but few papers have focused on identifying which particular aspect of MBSR directly correlates with it's degree of therapeutic efficacy. This study will use 7 well validated questionnaires to compare participants responses prior to, and following completion of an eight-week MBSR program at the North York General Hospital, as well as follow-up results at 1 month and 1 year post completion of the MBSR group.

Study Overview

Detailed Description

As above

Study Type

Interventional

Enrollment (Actual)

135

Phase

  • Phase 1

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • over 18 years old
  • suffer from a chronic health problem
  • referred by their physician

Exclusion Criteria:

  • acute illness (physical or psychiatric)
  • suicidal
  • problem use of alcohol or other substances
  • inability to do one hour of daily homework
  • inability to attend all 8 sessions

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: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mindfulness-based Stress Reduction group
All eligible participants attend a 3-hour weekly session, for 8 consecutive weeks, to learn meditation and simple Hatha Yoga techniques, and incorporate them into their daily lives.
Daily meditation, Hatha yoga,and cognitive restructuring
Other Names:
  • MBSR

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PSS-10
Time Frame: baseline, 8 weeks and follow-ups at 1 month and 1 year
Patients' Stress Scores on the PSS-10 are used to assess self-reported perceptions of stress at baseline, at 8 weeks when the intervention ends, and again at one month and one year follow-up (to see if any change is sustained).
baseline, 8 weeks and follow-ups at 1 month and 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Toronto Mindfulness Scale (TMS)
Time Frame: Baseline, 8 weeks and follow up at 1 month and 1 year
Measure of patients' self-reported capacity for detached curiosity / decentering (aspects of mindfulness), prior to intervention, at the end of the intervention (8 weeks), and at short-term (one month)and long-term (one year) follow-up.
Baseline, 8 weeks and follow up at 1 month and 1 year

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Katalin J Margittai, MD, North York General Hospital

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

January 1, 2009

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

April 1, 2012

Study Registration Dates

First Submitted

April 30, 2012

First Submitted That Met QC Criteria

May 13, 2012

First Posted (Estimate)

May 15, 2012

Study Record Updates

Last Update Posted (Estimate)

May 15, 2012

Last Update Submitted That Met QC Criteria

May 13, 2012

Last Verified

May 1, 2012

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.

Clinical Trials on Hypertension

Clinical Trials on Teaching Mindfulness-based Stress Reduction strategies

3
Subscribe