Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000485033
Ethics application status
Not yet submitted
Date submitted
4/06/2010
Date registered
11/06/2010
Date last updated
11/06/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of Mindfulness-Based Stress Reduction on pain and disease activity with people who have Rheumatoid Arthritis: Mechanisms of action
Scientific title
The effect of Mindfulness-Based Stress Reduction on pain and disease activity with people who have Rheumatoid Arthritis: Mechanisms of action
Secondary ID [1] 251949 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rheumatoid Arthritis 257523 0
Condition category
Condition code
Inflammatory and Immune System 257682 257682 0 0
Rheumatoid arthritis
Mental Health 257695 257695 0 0
Depression
Alternative and Complementary Medicine 257696 257696 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Mindfulness-Based Stress Reduction (MBSR) is an 8-week intervention which involves training in mindfulness meditation, a practice of self-regulating attention in a present-moment-oriented, non-judgmental manner, that lowers reactivity to stress triggers. Participants are required to attend a weekly two-hour training session, a one-day retreat (mid-intervention) and complete daily homework in the form of mindfulness exercises. During the course, participants will learn formal mindfulness practices of sitting meditation, walking meditation, and mindful yoga and how to integrate practice into everyday life. Training sessions will be administered in group classes (10 people per group) by the PhD candidate who is trained in teaching MBSR.
Intervention code [1] 256618 0
Treatment: Other
Comparator / control treatment
Participants will be randomly assigned to either the MBSR condition or treatment as usual. Treatment as usual means routine monitoring of participants by their Consultant Rheumatologists and General Practitioners (GPs) including monthly blood samples and regular joint assessments and participants' adherence to usual medication regimes.
Control group
Active

Outcomes
Primary outcome [1] 258587 0
Pain as measured by visual analogue, pain-related acceptance as measured by the Chronic Pain Acceptance Questionnaire (McCracken et al, 2004) and disease activity as assessed by the Disease Activity Score in 28 joints (DAS28-CRP), a composite measure reflecting the number of tender and swollen joints, C-reactive Protein and patients' assessment of general health on a 100-mm visual analogue scale.
Timepoint [1] 258587 0
Baseline, immediately post-intervention, 1, 3, 6 and 12 months follow-up
Secondary outcome [1] 264478 0
Depression/anxiety as measured by the Hospital and Anxiety Scale (Zigmond & Snaith, 2007) and psychological well-being (Ryff & Keyes, 1995).
Timepoint [1] 264478 0
Baseline, immediately post-intervention, 1, 3, 6 and 12 months follow-up

Eligibility
Key inclusion criteria
18 years of age, English fluency, diagnosis of Rheumatoid Arthritis according to criteria of the American College of Rheumatology
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded if they have major psychiatric illness, previous experience of mindfulness meditation, significant experience of any other type of meditation or are unable to attend study sessions. Additional exclusion criteria are active alcohol or drug dependency, concurrent participation in another clinical trial, and scheduled major surgery.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Potential participants will be sent a letter inviting them to take part in the study. The PhD student will contact interested participants by phone to discuss the study and to complete screening. Eligible participants will then give written consent to participate and be enrolled in the study. Allocation of participants to groups will be centrally randomized by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Using a computer program, participants will be assigned to groups on the basis of blocked randomization, to ensure that the number of males and females allocated to groups reflects the relative incidence of Rheumatoid Arthritis in each gender (approximately 3:1 female to male ratio within the general population).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/08/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 2683 0
New Zealand
State/province [1] 2683 0

Funding & Sponsors
Funding source category [1] 257107 0
University
Name [1] 257107 0
University of Auckland
Country [1] 257107 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
Faculty of Medical & Health Sciences
Park Road
Grafton
Auckland 1001
Country
New Zealand
Secondary sponsor category [1] 256369 0
None
Name [1] 256369 0
Address [1] 256369 0
Country [1] 256369 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 259148 0
Northern X Ethics Committee
Ethics committee address [1] 259148 0
Private Bag 92-522, Wellesley St
Auckland 1010
Ethics committee country [1] 259148 0
New Zealand
Date submitted for ethics approval [1] 259148 0
15/06/2010
Approval date [1] 259148 0
Ethics approval number [1] 259148 0

Summary
Brief summary
This study will evaluate the effectiveness of a mind-body intervention called Mindfulness-Based Stress Reduction to improve the psychological and physical well-being of individuals who have Rheumatoid Arthritis. The study will also explore how the intervention works i.e. the processes of change that occur during mindfulness training which may explain any significant improvements in outcome following the intervention. Participants will be randomly assigned to MBSR or treatment as usual and will be assessed at several time-points on a range of psychological, physical and clinical health outcomes.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31262 0
Address 31262 0
Country 31262 0
Phone 31262 0
Fax 31262 0
Email 31262 0
Contact person for public queries
Name 14509 0
Francesca Fogarty
Address 14509 0
c/o School of Psychological Medicine
Faculty of Medical and Health Sciences
University of Auckland
Private Bag 92019
Auckland 1001
New Zealand
Country 14509 0
New Zealand
Phone 14509 0
0064 21 752 117
Fax 14509 0
+64 9 373 7641
Email 14509 0
[email protected]
Contact person for scientific queries
Name 5437 0
Francesca Fogarty
Address 5437 0
c/o School of Psychological Medicine
Faculty of Medical and Health Sciences
University of Auckland
Private Bag 92019
Auckland 1001
New Zealand
Country 5437 0
New Zealand
Phone 5437 0
0064 21 752 117
Fax 5437 0
Email 5437 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.