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 |
| Secondary identifying numbers | 3200B0-112604 |
- 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
Scientific
Department of Psychosomatic Medicine
University Hospital Basel
Basel
4031
Switzerland
| grossmanp@uhbs.ch |
Study information
| Study design | Single-centre, randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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 study start date | 01/04/2007 |
| Completion date | 30/06/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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
4031
Switzerland
Sponsor information
University Hospital Basel (Switzerland)
University/education
University/education
Department of Psychosomatic Medicine
Hebelstrasse 2
Basel
4031
Switzerland
| grossmanp@uhbs.ch | |
| Website | http://www.dfbs.ch |
"ROR" |
https://ror.org/04k51q396 |
Funders
Funder type
Government
Swiss National Science Foundation (ref: 3200B0-112604) (Switzerland)
Private sector organisation / Trusts, charities, foundations (both public and private)
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Schweizerischer Nationalfonds, Swiss National Science Foundation, Fonds National Suisse de la Recherche Scientifique, Fondo Nazionale Svizzero per la Ricerca Scientifica, Fonds National Suisse, Fondo Nazionale Svizzero, Schweizerische Nationalfonds, SNF, SNSF, FNS
- Location
- Switzerland
St. Johnson Foundation (Switzerland)
No information available
Swiss MS Society (Switzerland)
No information available
Merck Serono (Switzerland)
No information available
Sanofi Aventis (France)
No information available
Biogen Dompe (Switzerland)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| 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 |
Editorial Notes
11/06/2019: Publication reference and total final enrolment added.
