- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01599143
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
Status
Completed
Conditions
Intervention / Treatment
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:
|
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.
Sponsor
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
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NYGH REB # 09-0041
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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