TREating FAtigue in Multiple Sclerosis: Cognitive behavioural therapy

Not Applicable

Completed

• Conditions: Multiple Sclerosis; Nervous System Diseases

• Registration Number: ISRCTN58583714
• Lead Sponsor: VU University Medical Center (Netherlands)

Brief Summary

1. 2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/23938046 2. 2015 results in https://www.ncbi.nlm.nih.gov/pubmed/25789625 (added 24/01/2019) 3. 2016 results of real-time assessment of fatigue in patients with multiple sclerosis. In https://www.ncbi.nlm.nih.gov/pubmed/27233157 (added 24/01/2019) 4. 2016 results of the effectiveness of cognitive behavioural therapy for the treatment of fatigue in patients with multiple sclerosis. In https://www.ncbi.nlm.nih.gov/pubmed/27772557 (added 24/01/2019) 5. 2016 results of the role of appraisal and coping style in relation with societal participation in fatigued patients with multiple sclerosis. In https://www.ncbi.nlm.nih.gov/pubmed/27372714 (added 24/01/2019) 6. 2017 results of the effectiveness of cognitive behavioural therapy to improve MS-related fatigue and participation. In https://www.ncbi.nlm.nih.gov/pubmed/28528567 (added 24/01/2019) 7. 2017 results of which psychological factors mediate change in fatigue during and after cognitive behavioural therapy. In https://www.ncbi.nlm.nih.gov/pubmed/29455894 (added 24/01/2019) 8. 2018 results in https://www.ncbi.nlm.nih.gov/pubmed/29313870 (added 24/01/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-07-19
• Study Completion: 2014-04-01
• Last Update Posted: 11 February 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Ambulatory MS patients fulfulling the following enrollment criteria:
1. Diagnosis of MS according to the criteria of McDonald
2. Able to walk with no more than one unilateral walking aid i.e. able to walk with no more than one unilateral walking aid
3. Suffering from fatigue, defined as a score higher than 35 on the subscale fatigue of the Checklist Individual Strength (CIS)
4. Age between 18-70 years

Exclusion Criteria

1. Patients using in the last three months prior to inclusion Amantadine, Modafinil, Ritalin or Pemoline for their fatigue
2. Major depression

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. Fatigue: checklist individual strength (CIS) subscale fatigue<br> 2. Participation: impact on participation and autonomy (IPA)<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. Medical outcome study short form 36 (SF36)<br> 2. Rehabilitation activities profile (RAP)<br> 3. Fatigue severity scale (FSS)<br> 4. Checklist individual strength (CIS) subscales motivation, concentration, activity<br> 5. Modified fatigue impact scale (MFIS)<br>