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

Phase 1

Completed

• Conditions: Cancer; Diabetes; Hypertension
• Interventions: Behavioral: Teaching Mindfulness-based Stress Reduction strategies

• Registration Number: NCT01599143
• Lead Sponsor: North York General Hospital

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.

Detailed Description

As above

Study Timeline

• Study Start: 2009-01
• Primary Completion: 2012-03
• Study Completion: 2012-04
• Study First Submitted: 2012-04-30
• Status Verified: 2012-05
• Study First Submitted QC: 2012-05-13
• Last Update Submitted: 2012-05-13
• Study First Posted: 2012-05-15
• Last Update Posted: 2012-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 135

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Mindfulness-based Stress Reduction group	Teaching Mindfulness-based Stress Reduction strategies	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.

Primary Outcome Measures

Name	Time	Method
PSS-10	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).

Secondary Outcome Measures

Name	Time	Method
Toronto Mindfulness Scale (TMS)	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.