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

Not Applicable

Completed

• Conditions: Multiple sclerosis; Nervous System Diseases

• Registration Number: ISRCTN21643919
• Lead Sponsor: niversity Hospital Basel (Switzerland)

Brief Summary

2010 results in: https://www.ncbi.nlm.nih.gov/pubmed/20876468 (added 11/06/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-05-16
• Study Completion: 2009-06-30
• Last Update Posted: 1 July 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 150

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. Quality of life: Hamburg Quality of Life Questionnaire in Multiple Sclerosis and Profile Quality of Life in Chronic Disorder<br> 2. Modified Fatigue Impact Scale<br> 3. Center for Epidemiological Studies Depression Scale<br><br> Timepoints of assessment: pre-Intervention, post-intervention and 6-month post-intervention.<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. Multiple Sclerosis Inventory of Cognition<br> 2. Personal Goal Attainment Scale<br> 3. Visual Analogue Quality of Life Scale<br> 4. Spielberger Trait Anxiety Scale<br> 5. Expanded Disability Status Scale<br> 6. 25-foot walk test<br><br> Timepoints of assessment: pre-Intervention, post-intervention and 6-month post-intervention.<br>