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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
189
The intervention is a newly developed website which consists of information about the mechanism and treatment of functional motor disorders. Furthermore self-help elements like exercises to perform at home and rehabilitation advice are added. The intervention is unguided.
University Medical Center Groningen
Groningen, Netherlands
Subjective general health Status on the Clinical Global Improvement scale
CGI, self-rated, 7-point scale of general health status
Time frame: 3 months
Subjective general health Status on the Clinical Global Improvement scale
CGI self-rated, 7-point scale of general health status
Time frame: 6 months
Quality of life on domains of RAND-36
extra question added to RAND-36 from WHOQuality Of Life scale
Time frame: 3 months
Quality of life on domains of RAND-36
extra question added to RAND-36 from WHO-Quality Of Life scale
Time frame: 6 months
Illness beliefs on the Illness Perception Questionnaire
Questions from the Illness Perception Questionnaire and newly devised questions about beliefs and understanding of functional motor disorders
Time frame: 3 months
Illness beliefs on the Illness Perception Questionnaire
Questions from the Illness Perception Questionnaire and newly devised questions about beliefs and understanding of functional motor disorders
Time frame: 6 months
Referral and other treatments on a questionnaire about referral and other treatments
Questions about future and past referrals to treatment
Time frame: 6 months
Symptom severity on the change in presenting symptoms scale
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Time frame: 3 months
Symptom severity on the change in presenting symptoms scale
Time frame: 6 months
Work and social adjustment
Work and Social Adjustment scale
Time frame: 6 months
Cost-effectivity in QALY's calculated by using the PCQ, MCQ and EQ5D
Analysis using: Patient Costs Questionnaire, Medical Costs Questionnaire, and EQ5D
Time frame: 6 months
Patient satisfaction with general care and the study intervention
Questions on satisfaction with general care and with the education and selfhelp intervention in particular
Time frame: 3 months
Patient satisfaction with general care and the study intervention
Questions on satisfaction with general care and with the education and selfhelp intervention in particular
Time frame: 6 months
Psychiatric outcome on the Patient Health Questionnaire
Time frame: 6 months
Fatigue on CIS-fatigue scale
Time frame: 6 months