Condition category
Nervous System Diseases
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status

Plain English Summary

Background and study aims
We intend to study the effectiveness of a psychotherapy-based online program to treat tiredness (fatigue) (ELEVIDA). It is based on a conceptualized model of fatigue and consists of eight modules. The programme will last for 8 weeks. The major aim is to reduce fatigue symptoms in patients with multiple sclerosis.

Who can participate?
Patients with multiple sclerosis who have access to internet

What does the study involve?
Patients will be randomly allocated to two groups: one group will receive the training right away and the other group (wait-list) will receive the training after the study is completed. The study involves psychological and nervous-response-related assessment before and after the training programme, and includes participation in a modern web-based intervention to treat fatigue over 8 weeks. The programme is developed in line with internationally accepted psychological therapy concepts.

What are the possible benefits and risks of participating?
The benefits would be a reduction of fatigue symptoms and to find ways to cope better with fatigue impairment. Risks are not expected.

Where is the study run from?
The study runs via the internet and is managed in University Medical Centre Eppendorf, Hamburg, Germany

When is the study starting and how long is it expected to run for?
The study starts in July 2014 and runs until May 2016

Who is funding the study?
Hertie Foundation (Gemeinnützige Hertie Stiftung) (Germany)

Who is the main contact?
Prof Christoph Heesen

Trial website

Contact information



Primary contact

Prof Christoph Heesen


Contact details

Martinistr. 52

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

Effectiveness of a fatigue management programme for patients with Multiple Sclerosis (MS)



Study hypothesis

The study follows 3 major aims:
1. To show effectiveness of an online program to treat fatigue in MS with a cognitive behavioural therapy (CBT) approach based on the concept of Van Kessel (2009).
2. To show that improvement of fatigue will also improve cognitive performance (attention) as well as anxiety and depression.
3. To show that Magnetic Resonance Imaging (MRI) connectivity measures (i.e. DTI and resting state fMRI) will change by the intervention.

We will further try to explore predictors and mediating factors of the intervention by the following hypotheses:
1. The intervention will change avoidance behavior and cognitive variables of illness perception (e.g.. symptom focussing).
2. Personality traits are predictive for treatment success.

Ethics approval

Ethics Committee of the Hamburg Chamber of Physicians, July 2014, PV 4772

Study design

Randomised controlled trial

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

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


Multiple Sclerosis (MS)


A pure online randomised-wait-list-control study with a subgroup undergoing clinical examination and MRI. Screening of suitable patients will be performed by checking fatigue scores in the Hamburg Quality of Life in MS fatigue subscale (HAQUAMS, Gold 2001) in the database of the UMC. Patients scoring >= 2 will be contacted. Patients have to apply for the study via a web-based tool provided by the University of Hamburg (see which we also applied in the depression study.
Patients fulfilling inclusion criteria based on data-input on the website will be randomised to the intervention group (IG) and the wait-list control group (CG).
1. IG participants will get a personal access code to the training tool.
2. Participants in the waiting list group will get information about their option to enter the FATIMA programme after the study. They will also get a brief explanation about the need for control groups in randomized controlled trials.

Intervention type



Not Applicable

Drug names

Primary outcome measure

Fatigue as measured by the Chalder Fatigue Scale (Cella & Chalder et al., 2010). Pre-post training comparisons immediately after the training and 3 months later will be calculated.

Secondary outcome measures

1. Fatigue: FSMC (Penner et al., 2009)
2. Anxiety and depression: Hospital Anxiety and Depression Scale (HADS, Zigmond & Snaith, 1983)
3. Quality of life: Hamburg Quality of Life Questionnaire in MS (HAQUAMS, Gold et al., 2001)
4. Cognitive self assessment: Multiple Sclerosis Neuropsychological Screening Questionnaire (MSNQ, Benedict et al., 2003)
5. Cognitive and behavioural responses to symptoms questionnaire (Skerett & Moss-Morris, 2006)
6. Brief Illness Perception Questionnaire (Broadbent et al., 2006)
7. Coping Self Efficacy Scale (CSES, Chesney et al., 2006)
8. Activity of daily life: Frenchay Activity Index (Turnbull et al., 2000)
9. Personality: Revised NEO Personality Inventory (Costa & McCrae,1992)

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

1. Definite MS according to McDonald criteria (Polman et al., 2010), relapsing-remitting (RR), primary and secondary-progressive (SP) MS course
2. Ability to answer read texts and to answer questionnaires via the internet
3. Fatigue-Scale-Motor-Cognition (FSMC) total fatigue score >= 43
4. Internet equipment at home (PC with internet access)
5. Interest to attend (agreement)

Participant type


Age group




Target number of participants


Participant exclusion criteria

1. Unclear diagnosis
2. Neuromyelitis optica
3. Major psychiatric disease (f.e. psychotic disease, but we will allow depressive disorders)

Recruitment start date


Recruitment end date



Countries of recruitment


Trial participating centre

Martinistr. 52

Sponsor information


Hertie Foundation (Germany) (Gemeinnützige Hertie Stiftung)

Sponsor details

Grüneburgweg 105

Sponsor type

Research organisation



Funder type

Research organisation

Funder name

Hertie Foundation (Germany) (Gemeinnützige Hertie Stiftung) Ref: P1130079

Alternative name(s)


Funding Body Type

private sector organisation

Funding Body Subtype

Trusts, charities, foundations (both public and private)



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

Basic results (scientific)

Publication list

2018 results in:

Publication citations

Additional files

Editorial Notes

21/03/2018: Publication reference added. 27/04/2016: The following changes were made to the trial record: 1. Ethics approval information added. 2. The overall trial end date was changed from 31/05/2016 to 26/05/2015. 26/06/2014: The following changes were made to the trial record: 1. The target number of participants was changed from 140 to 204. 2. The overall trial start date was changed from 01/06/2014 to 01/07/2014.