Online therapy programme for fatigue in multiple sclerosis
| ISRCTN | ISRCTN25692173 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN25692173 |
| Protocol serial number | P1130079 |
| Sponsor | Hertie Foundation (Germany) (Gemeinnützige Hertie Stiftung) |
| Funder | Hertie Foundation (Germany) (Gemeinnützige Hertie Stiftung) Ref: P1130079 |
- Submission date
- 08/04/2014
- Registration date
- 06/06/2014
- Last edited
- 21/03/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Plain English summary of protocol
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
Contact information
Scientific
Martinistr. 52
Hamburg
20246
Germany
| heesen@uke.de |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Effectiveness of a fatigue management programme for patients with Multiple Sclerosis (MS) |
| Study acronym | ELEVIDA |
| Study objectives | 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(s) | Ethics Committee of the Hamburg Chamber of Physicians, July 2014, PV 4772 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
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. |
| Key secondary outcome measure(s) |
1. Fatigue: FSMC (Penner et al., 2009) |
| Completion date | 26/05/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 204 |
| Key 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) |
| Key exclusion criteria | 1. Unclear diagnosis 2. Neuromyelitis optica 3. Major psychiatric disease (f.e. psychotic disease, but we will allow depressive disorders) |
| Date of first enrolment | 01/07/2014 |
| Date of final enrolment | 01/11/2014 |
Locations
Countries of recruitment
- Germany
Study participating centre
20246
Germany
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 | 01/09/2018 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
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.
