Condition category
Nervous System Diseases
Date applied
11/03/2008
Date assigned
16/05/2008
Last edited
11/08/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

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 measures

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

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

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

http://www.dfbs.ch

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, SNF

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes