Skip to content

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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN21643919
Enrollment
140
Registered
2008-05-16
Start date
2007-04-01
Completion date
Unknown
Last updated
2019-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple sclerosis Nervous System Diseases Multiple sclerosis

Interventions

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 me

Sponsors

University Hospital Basel (Switzerland)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Germany, Switzerland

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026