Effects of a cognitive-behavioural mindfulness intervention upon quality of life, depression and fatigue among multiple sclerosis (MS) patients

ISRCTN	ISRCTN21643919
DOI	https://doi.org/10.1186/ISRCTN21643919
Protocol serial number	3200B0-112604
Sponsor	University Hospital Basel (Switzerland)
Funders	Swiss National Science Foundation (ref: 3200B0-112604) (Switzerland), St. Johnson Foundation (Switzerland), Swiss MS Society (Switzerland), Merck Serono (Switzerland), Sanofi Aventis (France), Biogen Dompe (Switzerland)

Submission date: 11/03/2008
Registration date: 16/05/2008
Last edited: 11/06/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nervous System Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Paul Grossman
Scientific

Department of Psychosomatic Medicine
University Hospital Basel
Basel
4031
Switzerland

Email	grossmanp@uhbs.ch

Study information

Primary study design	Interventional
Study design	Single-centre, randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Effects of a cognitive-behavioural mindfulness intervention upon quality of life, depression and fatigue among multiple sclerosis (MS) patients
Study objectives	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(s)	Ethics approval received from the Ethics Committee of Basel (EKBB) on the 21st March 2007 (ref: 32/07)
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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.
Completion date	30/06/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	140
Total final enrolment	150
Key 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
Key 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
Date of first enrolment	01/04/2007
Date of final enrolment	30/06/2009

Locations

Countries of recruitment

Germany
Switzerland

Study participating centre

Department of Psychosomatic Medicine

Basel
4031
Switzerland

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	28/09/2010	11/06/2019	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

11/06/2019: Publication reference and total final enrolment added.