NCT01599143

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
135

participants targeted

Target at P75+ for phase_1 cancer

Timeline
Completed

Started Jan 2009

Typical duration for phase_1 cancer

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

April 30, 2012

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 15, 2012

Completed
Last Updated

May 15, 2012

Status Verified

May 1, 2012

Enrollment Period

3.2 years

First QC Date

April 30, 2012

Last Update Submit

May 13, 2012

Conditions

Keywords

MindfulnessPain Disorder (Chronic physical or mental health complaints:Fibromyalgia; Migraines; Back Pain; etc)Anxiety Disorder/Anxiety State

Outcome Measures

Primary Outcomes (1)

  • PSS-10

    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 Outcomes (1)

  • Toronto Mindfulness Scale (TMS)

    Baseline, 8 weeks and follow up at 1 month and 1 year

Study Arms (1)

Mindfulness-based Stress Reduction group

EXPERIMENTAL

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.

Behavioral: Teaching Mindfulness-based Stress Reduction strategies

Interventions

Daily meditation, Hatha yoga,and cognitive restructuring

Also known as: MBSR
Mindfulness-based Stress Reduction group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

NeoplasmsDiabetes MellitusHypertensionSomatoform DisordersFibromyalgiaMigraine DisordersBack PainAnxiety Disorders

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesVascular DiseasesCardiovascular DiseasesMental DisordersMuscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System DiseasesHeadache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Katalin J Margittai, MD

    North York General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Psychiatry, University of Toronto

Study Record Dates

First Submitted

April 30, 2012

First Posted

May 15, 2012

Study Start

January 1, 2009

Primary Completion

March 1, 2012

Study Completion

April 1, 2012

Last Updated

May 15, 2012

Record last verified: 2012-05