TREating FAtigue in Multiple Sclerosis: Cognitive behavioural therapy
| ISRCTN | ISRCTN58583714 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN58583714 |
| Protocol serial number | ZonMw 60-61300-98-024; CCMO NL33451.029.10 |
| Sponsor | VU University Medical Center (Netherlands) |
| Funder | The Netherlands Organization for Health Research and Development Rehabilitation Research Program II, Fonds NutsOhra (ZonMw 60-61300-98-024) |
- Submission date
- 13/07/2011
- Registration date
- 19/07/2011
- Last edited
- 24/01/2019
- 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 Heleen Beckerman
Scientific
Scientific
Dept Rehabilitation Medicine
VU University Medical Center
PO BOX 7057
Amsterdam
1007 MB
Netherlands
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicenter two armed randomized trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | A randomized clinical trial disabling fatigue in multiple sclerosis occurs frequently. How should it be treated? |
| Study acronym | TREFAMS-C |
| Study objectives | What is the effect of Cognitive Behavioural Therapy (CBT) on participation and fatigue in patients with Multiple Sclerosis (MS)? Can this effect be explained by altered cognitions about fatigue? |
| Ethics approval(s) | Medical Ethics Committee of the VU University Medical Center, 5 April 2011 ref: 2010/289 |
| Health condition(s) or problem(s) studied | Multiple Sclerosis |
| Intervention | 1. Cognitive Behavioural Therapy (CBT) with two arms 2. CBT will focus on the fatigue maintaining behaviour and cognitions of the patient 3. CBT consists of 12 individual therapist-supervised 45-minute therapy sessions in a period of 4 months, and an individualized schedule to gradually expand participation 4. The time interval between therapy session will be gradually increased as therapy progresses 5. Control treatment for each RCT of the TREFAMS-ACE research programme consists of currently available standardized written patient information and will be provided in a standardized manner by an MS nurse 6. Patients receive this information package personally in the first week 7. In week 6 and 16, 45-minute appointments with the MS nurse will be scheduled in order to ask questions about the information package 8. This control treatment covers two important aspects that we want to control for: 8.1. Good information about MS related fatigue, and 8.2. Attention of a professional who has experience in MS in order to reassure the patient that his concerns or questions will be taken seriously 9. The MS nurses will receive instructions on how to provide the information without additional therapeutic interventions or specific personal advises |
| Intervention type | Other |
| Primary outcome measure(s) |
1. Fatigue: checklist individual strength (CIS) subscale fatigue |
| Key secondary outcome measure(s) |
1. Medical outcome study short form 36 (SF36) |
| Completion date | 01/04/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 70 Years |
| Sex | All |
| Target sample size at registration | 90 |
| Key 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 |
| Key exclusion criteria | 1. Patients using in the last three months prior to inclusion Amantadine, Modafinil, Ritalin or Pemoline for their fatigue 2. Major depression |
| Date of first enrolment | 15/09/2011 |
| Date of final enrolment | 01/04/2014 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Dept Rehabilitation Medicine
Amsterdam
1007 MB
Netherlands
1007 MB
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | 01/11/2016 | Yes | No | |
| Results article | results | 19/03/2015 | 24/01/2019 | Yes | No |
| Results article | results | 13/02/2018 | 24/01/2019 | Yes | No |
| Results article | results of the effectiveness of cognitive behavioural therapy for the treatment of fatigue in patients with multiple sclerosis. | 01/11/2016 | 24/01/2019 | Yes | No |
| Results article | results of the effectiveness of cognitive behavioural therapy to improve MS-related fatigue and participation. | 01/10/2017 | 24/01/2019 | Yes | No |
| Results article | results of the role of appraisal and coping style in relation with societal participation in fatigued patients with multiple sclerosis. | 01/10/2016 | 24/01/2019 | Yes | No |
| Results article | results of which psychological factors mediate change in fatigue during and after cognitive behavioural therapy. | 01/03/2018 | 24/01/2019 | Yes | No |
| Protocol article | protocol | 12/08/2013 | Yes | No | |
| Other publications | In | 01/11/2016 | 24/01/2019 | Yes | No |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
24/01/2019: Publication references added
