Condition category
Nervous System Diseases
Date applied
13/07/2011
Date assigned
19/07/2011
Last edited
15/08/2013
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Heleen Beckerman

ORCID ID

Contact details

Dept Rehabilitation Medicine
VU University Medical Center
PO BOX 7057
Amsterdam
1007 MB
Netherlands

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

ZonMw 60-61300-98-024; CCMO NL33451.029.10

Study information

Scientific title

A randomized clinical trial disabling fatigue in multiple sclerosis occurs frequently. How should it be treated?

Acronym

TREFAMS-C

Study hypothesis

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

Medical Ethics Committee of the VU University Medical Center, 5 April 2011 ref: 2010/289

Study design

Multicenter two armed randomized trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

1. Fatigue: checklist individual strength (CIS) subscale fatigue
2. Participation: impact on participation and autonomy (IPA)

Secondary outcome measures

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

Overall trial start date

15/09/2011

Overall trial end date

01/04/2014

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

90

Participant exclusion criteria

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

Recruitment start date

15/09/2011

Recruitment end date

01/04/2014

Locations

Countries of recruitment

Netherlands

Trial participating centre

Dept Rehabilitation Medicine
Amsterdam
1007 MB
Netherlands

Sponsor information

Organisation

VU University Medical Center (Netherlands)

Sponsor details

Dept Rehabilitation Medicine
PO Box 7057
Amsterdam
1007 MB
Netherlands

Sponsor type

University/education

Website

http://www.vumc.com/patientcare/

Funders

Funder type

Research organisation

Funder name

The Netherlands Organization for Health Research and Development Rehabilitation Research Program II, Fonds NutsOhra (ZonMw 60-61300-98-024)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/23938046

Publication citations

  1. Protocol

    Beckerman H, Blikman LJ, Heine M, Malekzadeh A, Teunissen CE, Bussmann JB, Kwakkel G, van Meeteren J, de Groot V, , The effectiveness of aerobic training, cognitive behavioural therapy, and energy conservation management in treating MS-related fatigue: the design of the TREFAMS-ACE programme., Trials, 2013, 14, 250, doi: 10.1186/1745-6215-14-250.

Additional files

Editorial Notes