Condition category
Nervous System Diseases
Date applied
08/04/2014
Date assigned
06/06/2014
Last edited
27/04/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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
heesen@uke.de

Trial website

Contact information

Type

Scientific

Primary contact

Prof Christoph Heesen

ORCID ID

Contact details

Martinistr. 52
Hamburg
20246
Germany
-
heesen@uke.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

P1130079

Study information

Scientific title

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

Acronym

ELEVIDA

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

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

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 (MS)

Intervention

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 www.unipark.com) 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

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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)
Exploratory:
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

01/07/2014

Overall trial end date

26/05/2015

Reason abandoned

Eligibility

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

Patient

Age group

Adult

Gender

Both

Target number of participants

204

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

01/07/2014

Recruitment end date

01/11/2014

Locations

Countries of recruitment

Germany

Trial participating centre

Martinistr. 52
Hamburg
20246
Germany

Sponsor information

Organisation

Hertie Foundation (Germany) (Gemeinnützige Hertie Stiftung)

Sponsor details

Grüneburgweg 105
Frankfurt
60323
Germany
-
KochE@ghst.de

Sponsor type

Research organisation

Website

Funders

Funder type

Research organisation

Funder name

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

Alternative name(s)

Hertie Foundation, Hertie-Stiftung

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

Germany

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

Publication citations

Additional files

Editorial Notes

On 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. On 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.