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Trial registered on ANZCTR


Registration number
ACTRN12612001083886
Ethics application status
Approved
Date submitted
9/10/2012
Date registered
9/10/2012
Date last updated
9/10/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomized, controlled trial of mindful meditation in people with Multiple Sclerosis: Effects on mood, inflammation and volume of the hippocampus.
Scientific title
The neuroprotective impact of mindfulness in Multiple Sclerosis(MS)
Secondary ID [1] 280702 0
None
Universal Trial Number (UTN)
U1111-1132-0870
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Sclerosis 286740 0
Condition category
Condition code
Neurological 287040 287040 0 0
Multiple sclerosis
Inflammatory and Immune System 287207 287207 0 0
Autoimmune diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Mindfulness Meditation training will be conducted in groups of approximately 10 patients per group. Participants will be contacted by the trained Mindfulness therapist (Alice Shires) and given information about the group that they have been allocated to. Each group session will be 2 hours and will be conducted on a weekly basis for 8 weeks.

Mindfulness training is a form of attentional training which requires a daily practice of deliberately focusing attention on one’s own experience from moment to moment and in a non-judgmental way. Participants are helped to develop the ability to quickly recognise and inhibit their typical response to emerging thoughts, to prevent distractibility and refocus their attention on the breath.
As participants develop these skills, they are then taught to scan their body systematically and develop an ability to feel both salient and more subtle sensations while purposefully inhibiting habitual, learned reactions. As participants have learned to do with their thoughts, participants develop an increasing ability to accept whatever arises in their body from moment to moment while remaining as non-reactive as possible.
Participants will be taught mindful meditation techniques which are practised in the group session and then particpants are encouraged to continue daily practice between group sessions using guided meditation practice via CDs distributed in the group sessions.
Intervention code [1] 285119 0
Treatment: Other
Comparator / control treatment
The attending to music control condition will control for non-specific effects of: attending a group; therapist attention and rapport; and the act of concentrating on an activity both within session and between sessions. Participants will attend the same number of sessions as the mindfuless group for a matched time period (2 hour sessions weekly over 8 weeks), and will be encouraged to practice attending to music in between sessions by listening to music on CD's distributed in the group sessions . The therapist will guide participants through listening to relaxing music within the sessions.
Control group
Active

Outcomes
Primary outcome [1] 287414 0
Changes in hippocampal volume and connectivity.
Hippocampal Volume: will be measured at baseline 6, 12 months and 24 months follow up.
MRI scans will be digitized and sent to Professor Luder for analysis. The analysis will be based on previous pilot work (see Luders et al., 2009).
Timepoint [1] 287414 0
Baseline to 6, 12 and 24 month follow-up.
Primary outcome [2] 287415 0
Reduced risk of relapse for those with a previous history of depression.
Relapses:
Neurologist reported relapses will be assessed through the medical files. Self-reported relapses will be assessed via monthly email contact.
Timepoint [2] 287415 0
Baseline to 6, 12 and 24 month follow-up.
Secondary outcome [1] 298091 0
Cortisol: We will assess Hypothalamic-pituitary-adrenal (HPA) axis functioning by measuring cortisol on wakening and in the evening. Cortisol exists in free form in saliva. Saliva will be collected using cotton dental rolls.
Timepoint [1] 298091 0
Post-treatment, 6 month follow-up, 12 month follow-up and 2 year follow-up.
Secondary outcome [2] 298092 0
Depression Centre for Epidemiological Studies (Depression) Scale (CES-D) will be used to asess for depression.The CES-D contains four factors that measure depressed affect, positive effect, somatic complaints or retarded activity and interpersonal relationships.
Timepoint [2] 298092 0
Post-treatment, 6 month follow-up, 12 month follow-up and 2 year follow-up.
Secondary outcome [3] 299474 0
Anxiety and stress will be measures by the Depression Anxiety abd Stress scale (DASS)
Timepoint [3] 299474 0
Post-treatment, 6 month follow-up, 12 month follow-up and 2 year follow-up.
Secondary outcome [4] 299475 0
Quality of life (QOL): will be assessed at pre-treatment, post-treatment and each follow-up using the WHOQOL-BREF (The WHOQOL Group; 26-item), the brief version of the WHOQOL-100. The WHOQOL-BREF subscales are highly correlated with the WHOQOL-100 subscales (about r=.9), and they assess four QOL domains: physical health, psychological health, social relationships, and environment.
Timepoint [4] 299475 0
Post-treatment, 6 month follow-up, 12 month follow-up and 2 year follow-up
Secondary outcome [5] 299476 0
Fatigue severity will be assessed at pre-treatment, post-treatment and each follow-up using the Fatigue Severity Scale (FSS) (Krupp et al., 1989), a 9-item self-report scale assessing functional impairments resulting from fatigue over the past week, on 7-point Likert scales.
Timepoint [5] 299476 0
Post-treatment, 6 month follow-up, 12 month follow-up and 2 year follow-up

Eligibility
Key inclusion criteria
Participants will be patients with a confirmed diagnosis from a Consultant Neurologist of MS
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(1) an Expanded Disability Status Scale (EDSS) < 6; (2) current serious psychiatric condition (excluding depressive and anxiety disorders), such as schizophrenia, bipolar disorder or drug and alcohol abuse; (3) evidence of cognitive impairment that would compromise their ability to take part in the study, as assessed by the Mini-Mental State Examination; (4) current MS exacerbation; (5) inability to complete the required questionnaires.

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)
Participants will be invited to take part in their study at the out-patient appointment. Participants will be explained about the study and given the participant information statement that will be approved by the relevant ethics committee. Those participants who consent will be given a series of questionnaires and be asked to either complete them before leaving the hospital or bring them to their next appointment for assessment. All participants will attend an assessment session where they will be assessed for the presence of a history of clinical depression by a research assistant prior to allocation. The participants will also be screened for any other exclusion criteria. Once the participants have completed the baseline assessment, an independent researcher blind to the patient's characteristics will reveal the allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization will be determined according to the www.randomizer.org. and concealed until after the participant has completed the baseline assessment
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
A single-blind, randomized controlled trial.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/12/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
72
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285614 0
Self funded/Unfunded
Name [1] 285614 0
Country [1] 285614 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
University of Sydney
Sydney 2006
NSW Australia
Country
Australia
Secondary sponsor category [1] 284443 0
Charities/Societies/Foundations
Name [1] 284443 0
MS Australia NSW
Address [1] 284443 0
P.O. BOX 210, Lidcombe, NSW 2141
Country [1] 284443 0
Australia
Other collaborator category [1] 276924 0
Individual
Name [1] 276924 0
Dr. Eileen Lueders
Address [1] 276924 0
Laboratory of NeuroImaging,
Department of Neurology,UCLA
School of Medicine, 635 Charles
Young Drive South, Suite 225, Los
Angeles, CA90095-7334, USA.
Country [1] 276924 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287532 0
Western Sydney Local health District
Ethics committee address [1] 287532 0
Ethics committee country [1] 287532 0
Australia
Date submitted for ethics approval [1] 287532 0
Approval date [1] 287532 0
19/04/2012
Ethics approval number [1] 287532 0
HREC2011/12/4.5(3432)AUREDHREC/11/WMEAD/301
Ethics committee name [2] 287612 0
The University of Sydney
Ethics committee address [2] 287612 0
Ethics committee country [2] 287612 0
Australia
Date submitted for ethics approval [2] 287612 0
Approval date [2] 287612 0
11/05/2012
Ethics approval number [2] 287612 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34336 0
Address 34336 0
Country 34336 0
Phone 34336 0
Fax 34336 0
Email 34336 0
Contact person for public queries
Name 17583 0
Alice Shires
Address 17583 0
School of Psychology
University of Sydney
Sydney 2006
NSW
Australia
Country 17583 0
Australia
Phone 17583 0
61 2 93853027
Fax 17583 0
Email 17583 0
a.shires@unsw.edu.au
Contact person for scientific queries
Name 8511 0
Professor Louise Sharpe
Address 8511 0
School of Psychology
University of Sydney
Sydney 2006
NSW
Australia
Country 8511 0
Australia
Phone 8511 0
61 2 93514558
Fax 8511 0
61 2 93517328
Email 8511 0
louise.sharpe@sydney.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.