Functional Motor Disorder Clinical Trial
Official title:
Self-Help and Education on the Internet for Functional Motor Disorders, a Randomised Controlled Trial (SHIFT)
A randomised trial to the effect of a newly developed education and self help intervention for patients with a functional motor disorder on general health, quality of life, illness perception, symptom severity and other secondary outcome measures.
Patients will be referred to the study from all neurology centers in the Netherlands that are
found willing to participate. After informed consent is acquired, patients will be randomised
into one of these two groups: usual care only or the education and self help intervention
added to usual care. At baseline, after 3 months and after 6 months patients will fill out
questionnaires at home online or on paper.
Patients will not be blinded for the intervention. The researcher is blinded during analysis
of the data. During the study contact between the researcher and the participants will be
restricted to research related topics. All contact between participants and the researcher
will be documented.
To increase generalisability and applicability in clinical practice after the trial the
investigators have chosen to add the intervention to usual care and to keep exclusion
criteria to a minimum.
Our education and self help internet intervention is an especially designed website with an
educational approach. The content of the intervention is written by a team of international
experts and consists of education about the mechanism of functional motor disorders and it's
treatment and of self help advice and exercises. During the trial the website will only be
accessible with a log-in. The education and self help internet intervention is
self-explanatory and unguided.
The medical ethical committee of the University Medical Center Groningen has taken our
research under review and has decided this study does not fall under the scope of the Medical
Research Involving Human Subjects Act (WMO-Wet Mensgebonden Onderzoek).
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