Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000217202
Ethics application status
Approved
Date submitted
24/04/2009
Date registered
29/04/2009
Date last updated
5/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Clinical Effectiveness of using Mindfulness-Based Cognitive Therapy to Improve Coping and Quality of Life in People with Spinal Cord Injury.
Scientific title
Clinical Effectiveness of using Mindfulness-Based Cognitive Therapy to Improve Coping and Quality of Life in People with Spinal Cord Injury.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Spinal Cord Injury 4658 0
Condition category
Condition code
Mental Health 4964 4964 0 0
Depression
Injuries and Accidents 4995 4995 0 0
Fractures

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Mindfulness-Based Cognitive Therapy (MBCT).
Mindfulness is a technique or "mode of being" that is about accepting and being content in the present moment with a non-judgemental and curious attitude. The MBCT group program involves attending 8-weekly group therapy sessions (2 hour duration). Groups will consist of a maximum of 10 participants at any one time. The group program is modified and adapted from Jon Kabat-Zinn's Mindfulness Based Stress Reduction (MBSR) work.
Intervention code [1] 4424 0
Treatment: Other
Comparator / control treatment
Waitlist Controls will not be required to change their daily routines over a 10 week period. At the end of this 10 week period they will be offered the opportunity to participate in the MBCT group program that will be exactly the same as that received by the participants in the MBCT group program condition.
Control group
Active

Outcomes
Primary outcome [1] 5813 0
Improvement in four quality of life (QoL)domains (health and functioning, social and economic, psychological and spiritual and family) as measured by the "Spinal Cord Version of QoL" questionnaire.
Timepoint [1] 5813 0
One week prior to commencement of MBCT group program (initial interview), Week 8 (final group session) and 3-months followup.
Secondary outcome [1] 241815 0
Improvements in Mindfulness Skills utilized by the participants which will be measured by the "Mindfulness Attention Awareness Scale (MAAS)" questionnaire.
Timepoint [1] 241815 0
One week prior to commencement of MBCT group program (initial interview), Week 8 (final group session) and 3-months followup.

Eligibility
Key inclusion criteria
30 Spinal Cord Injured individuals with a duration of spinal cord injury greater than 6 months.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Spinal Cord injured individuals will be excluded from the study if they suffer from delusional or psychotic thinking, have a significant cognitive deficit, or have concurrent head injury, are currently considered high risk of suicide, are suffering from extreme anxiety, or suffering from Post Traumatic Stress Disorder.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
24/05/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4845 0
University
Name [1] 4845 0
Neurotrauma Research Program Grant -
Western Australian Institute for Medical Research (WAIMR)
Country [1] 4845 0
Australia
Primary sponsor type
University
Name
WA Institue of Medical Research (WAIMR)
Address
University of Western Australia
B Block, Sir Charles Gairdner Hospital Nedlands WA 6009
Country
Australia
Secondary sponsor category [1] 4382 0
None
Name [1] 4382 0
Address [1] 4382 0
Country [1] 4382 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6901 0
Royal Perth Hospital Human Research Ethics Committee
Ethics committee address [1] 6901 0
Ethics committee country [1] 6901 0
Australia
Date submitted for ethics approval [1] 6901 0
Approval date [1] 6901 0
Ethics approval number [1] 6901 0
EC 2008/209
Ethics committee name [2] 6902 0
Curtin University of Technology Human Research Ethics Committee
Ethics committee address [2] 6902 0
Ethics committee country [2] 6902 0
Australia
Date submitted for ethics approval [2] 6902 0
Approval date [2] 6902 0
Ethics approval number [2] 6902 0
HR 23/2009

Summary
Brief summary
This research project aims to evaluate prospectively the effectiveness of an 8-week Mindfulness-Based Cognitive Therapy (MBCT) group program implemented for individuals with a Spinal Cord Injury.
The study hypothesis is that the implementation of an 8-week MBCT group program for Spinal Cord Injured individuals will facilitate improvements in psychosocial and behavioural functional outcomes post group program and these improvements in therapeutic outcomes will be maintained up to 3 months after completion of the MBCT group program.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29529 0
Address 29529 0
Country 29529 0
Phone 29529 0
Fax 29529 0
Email 29529 0
Contact person for public queries
Name 12776 0
Dr Michelle Byrnes
Address 12776 0
School of Psychology
Curtin University of Technology
GPO Box U1987
WA 6845
Country 12776 0
Australia
Phone 12776 0
+61 8 9266 2366
Fax 12776 0
Email 12776 0
M.Byrnes@curtin.edu.au
Contact person for scientific queries
Name 3704 0
Dr Michelle Byrnes
Address 3704 0
School of Psychology
Curtin University of Technology
GPO Box U1987
WA 6845
Country 3704 0
Australia
Phone 3704 0
+61 8 9266 2366
Fax 3704 0
Email 3704 0
M.Byrnes@curtin.edu.au

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.