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

Hypertension Clinical Trial

— mbsr  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01599143
• Other study ID #: NYGH REB # 09-0041
• Status: Completed
• Phase: Phase 1
• First received: April 30, 2012
• Last updated: May 13, 2012
• Start date: January 2009
• Est. completion date: April 2012

Study information

• Verified date: May 2012
• Source: North York General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Description:

As above

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: April 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Cancer
• Diabetes
• Hypertension

Intervention

Behavioral:
• Teaching Mindfulness-based Stress Reduction strategies
Daily meditation, Hatha yoga,and cognitive restructuring

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
North York General Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Toronto Mindfulness Scale (TMS)	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	No