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

Completed (inferred)Not a drug-phase studyRelapsing and progressiveISRCTN25692173

What it found

Paper found, not read

A paper reports the results; we have not read it yet. See Papers below.

What it measured

Main 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.

    Fatigue

Other measures (1)

  • 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 response

    Thinking and memoryFatigueMood and sleepQuality of life (reported by participants)

Who could take part

Relapsing and progressive

Show the full criteria

Inclusion criteria

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

Exclusion criteria

Not separately supplied in the registry.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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

Papers

Loading reviews and guidelines…

History

    1. Started

      Jul 2014

    2. Finished

      May 2015

    Assembled by software from public sources.