Contact information
Type
Scientific
Primary contact
Dr Paul Grossman
ORCID ID
Contact details
Department of Psychosomatic Medicine
University Hospital Basel
Basel
4031
Switzerland
-
grossmanp@uhbs.ch
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
3200B0-112604
Study information
Scientific title
Effects of a cognitive-behavioural mindfulness intervention upon quality of life, depression and fatigue among multiple sclerosis (MS) patients
Acronym
Study hypothesis
In comparison to conventional optimal medical management, multiple sclerosis (MS) patients assigned to a mindfulness-based stress-reduction (MBSR) intervention will manifest greater improvements in quality of life and reductions in depression and fatigue.
Ethics approval
Ethics approval received from the Ethics Committee of Basel (EKBB) on the 21st March 2007 (ref: 32/07)
Study design
Single-centre, randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet.
Condition
Multiple sclerosis
Intervention
Intervention:
Mindfulness-based stress reduction. 8-week group (10 - 15 participants) intervention, 2.5 hours per week with one additional whole-day session and optimal conventional medical care.
Control:
Optimal conventional medical care alone.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
1. Quality of life: Hamburg Quality of Life Questionnaire in Multiple Sclerosis and Profile Quality of Life in Chronic Disorder
2. Modified Fatigue Impact Scale
3. Center for Epidemiological Studies Depression Scale
Timepoints of assessment: pre-Intervention, post-intervention and 6-month post-intervention.
Secondary outcome measures
1. Multiple Sclerosis Inventory of Cognition
2. Personal Goal Attainment Scale
3. Visual Analogue Quality of Life Scale
4. Spielberger Trait Anxiety Scale
5. Expanded Disability Status Scale
6. 25-foot walk test
Timepoints of assessment: pre-Intervention, post-intervention and 6-month post-intervention.
Overall trial start date
01/04/2007
Overall trial end date
30/06/2009
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Both males and females, aged 18 - 70 years
2. Verified diagnosis of MS with an expanded disability status scale score of less than or equal to 6.0 (from no disability to moderately severe disability MS) and no more than one step increase within the last year. We include patients with the followng types of disease:
2.1. Relapsing-remitting MS and no more than two exacerbations within the last year, with at least three months since start of last relapse; or
2.2. Secondary progressive disease
3. Patients who have not initiated or changed treatment with a disease-modifying drug within the past three months
4. Patients who have not been treated with corticosteroids within the previous 30 days
5. Time since onset of disease will be evaluated and considered in statistical analyses but will not form a criterion for enrolment into the study
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
140
Total final enrolment
150
Participant exclusion criteria
1. Serious psychological disorders other than depression and anxiety syndromes, such as psychotic disorders, bipolar disorders, borderline personality disorders or active substance abuse disorders
2. Evidence of dementia as indicated by testing below the fifth percentile in at least three of six dimensions of neuropsychological functioning (i.e. attention and concentration, processing speed, executive function, verbal memory, and verbal processing)
3. Suicidality
4. Other life-threatening or severely disabling physical disorders
5. Current MS exacerbation
6. Other disorders of the central nervous system (CNS) besides MS
7. Symptomatic medication has been altered within the past three months
8. Pregnancy
9. Inability to understand written and spoken German
Recruitment start date
01/04/2007
Recruitment end date
30/06/2009
Locations
Countries of recruitment
Germany, Switzerland
Trial participating centre
Department of Psychosomatic Medicine
Basel
4031
Switzerland
Sponsor information
Organisation
University Hospital Basel (Switzerland)
Sponsor details
Department of Psychosomatic Medicine
Hebelstrasse 2
Basel
4031
Switzerland
-
grossmanp@uhbs.ch
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
Swiss National Science Foundation (ref: 3200B0-112604) (Switzerland)
Alternative name(s)
Swiss National Science Foundation, Fonds National Suisse de la Recherche Scientifique, Fondo Nazionale Svizzero per la Ricerca Scientifica, Fonds National Suisse, Fondo Nazionale Svizzero, Schweizerischer Nationalfonds, SNSF, FNS, SNF
Funding Body Type
private sector organisation
Funding Body Subtype
Trusts, charities, foundations (both publically funded and privately funded)
Location
Switzerland
Funder name
St. Johnson Foundation (Switzerland)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Swiss MS Society (Switzerland)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Merck Serono (Switzerland)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Sanofi Aventis (France)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Biogen Dompe (Switzerland)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2010 results in: https://www.ncbi.nlm.nih.gov/pubmed/20876468 (added 11/06/2019)