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Mindfulness Based Cognitive Therapy for subjective fatigue in patients with multiple sclerosis: a prospective cohort study on effectiveness and feasibility.

Mindfulness Based Cognitive Therapy for subjective fatigue in patients with multiple sclerosis: a prospective cohort study on effectiveness and feasibility. - Mind-MS-study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON37684
Enrollment
50
Registered
2012-06-04
Start date
2012-07-01
Completion date
Unknown
Last updated
2024-04-29

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

Conditions

MS Multiple sclerosis

Interventions

The MBCT protocol we will use is described by Segal et al. (2004) and is a group intervention. We made some adaptations for fatigue, because Segal*s protocol was developed for patients with recurren

Sponsors

Orbis Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Age 18-60 years; clinical definite MS diagnosis according to the Mac Donald classification criteria; severe fatigue symptoms (a score * 35 on the subscale subjective fatigue of the Checklist Individual Strenght-20); motivation for the training and daily practicing at home for 45 minutes; fluent in Dutch.

Exclusion criteria

Exclusion criteria: Primary progressive MS; MS relapse or corticosteroid use within the past 6 weeks; Other neurological disorders than MS; Somatic co-morbidity related with fatigue (e.g. diabetes mellitus, inflammatory bowel disease, chronic fatigue syndrome); a current clinical depressive episode according the DSM-IV criteria; other severe psychiatric disorders (psychosis, social phobia, delirium, dementia, alcohol or substance abuse); previous mindfulness training.

Design outcomes

Primary

MeasureTime frame
Fatigue will be measured with the fatigue severity subscale of the Checklist Individual Strenght-20 (CIS-20).This subscale consists of 8 items, each scored on a 7-point Likert scale with scores ranging from 8 to 56. A score of 35 or higher on the subscale indicates severe fatigue.

Secondary

MeasureTime frame
Symptoms of anxiety and depression will be measured with the Hospital Anxiety and Depression Scale (HADS). The HADS is specially designed to screen anxiety and depression in physically ill patients and does not include somatic symptoms. Both subscales consist of 7 items, with scores ranging from 0-21. Separate scores of 8 or higher or joint scores of 12 or higher are interpreted as high scores, indicating more intensity of anxiety or depression. Catastrophizing about fatigue will be measured with the Fatigue Catastrophizing Scale (FCS), which is an adapted version of the Pain Catastrophizing Scale (PCS). The PCS is a 13-item questionnaire that measures the frequency of catastrophizing thoughts reported by patients about the pain they experience. Psychometric properties of the PCS appeared adequate (Van Damme, 2000; Crombez, 1998). Bol et al. (2010) adapted the PCS by replacing the word *pain* by the word *fatigue* in all items. Scoring alternatives range from *strongly disagree* to *strongly agree*. Three MS-related items were added by Bol et al. (2010) (*When I am tired, this is a signal there is something wrong in my brain*, *When I am tired, this is a warning for physical decline*, *When I am tired, this is a sign that my MS is getting worse*). The FCS consists of 16 items, with scores ranging from 0-64 and with higher scores indicating higher intensity Sleeping problems will be measured with the subscale sleep of the Dutch version of the Symptom Checklist-90 (SCL-90, Arrindell & Ettema, 1986), a frequently used questionnaire for several psychological complaints. The subscale consists of three items, with scores ranging from 3 to 15. Higher scores indicate lower quality of sleep. As a measure of perceived life satisfaction, we will use the Life Satisfaction questionnaire (LiSat-9). It consists of one question about satisfaction with life as a whole and eight questions about satisfaction within the following life domains; self-care abili

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)