Clinical trial NCT02589886: Self-help and Education on the Internet for Functional Motor Disorders
Official title: Self-Help and Education on the Internet for Functional Motor Disorders, a Randomised Controlled Trial (SHIFT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Functional Motor Disorder
Keywords: Self-help
Education
e-Health
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2015-10-28
Enrollment: 189
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

* Diagnosis of functional motor symptom from a neurologist
* The motor symptom(s) cause(s) distress or impairment in social, occupational or other important areas of functioning.
* Able to read Dutch
* Access to a computer with internet connection on a regular basis

Exclusion Criteria:

* Incapacitated (Not able to provide informed consent)
* Accidental finding of a motor symptom in a patient with other (functional) complaints.
* Known existing visitor of the (previously available, but currently offline) translated version of a website by Dr. Jon Stone

Primary outcomes:
measure: Subjective general health Status on the Clinical Global Improvement scale
timeFrame: 3 months
measure: Subjective general health Status on the Clinical Global Improvement scale
timeFrame: 6 months
Secondary outcomes:
measure: Quality of life on domains of RAND-36
timeFrame: 3 months
measure: Quality of life on domains of RAND-36
timeFrame: 6 months
measure: Illness beliefs on the Illness Perception Questionnaire
timeFrame: 3 months
measure: Illness beliefs on the Illness Perception Questionnaire
timeFrame: 6 months
measure: Referral and other treatments on a questionnaire about referral and other treatments
timeFrame: 6 months
measure: Symptom severity on the change in presenting symptoms scale
timeFrame: 3 months
measure: Symptom severity on the change in presenting symptoms scale
timeFrame: 6 months
measure: Work and social adjustment
timeFrame: 6 months
measure: Cost-effectivity in QALY's calculated by using the PCQ, MCQ and EQ5D
timeFrame: 6 months
measure: Patient satisfaction with general care and the study intervention
timeFrame: 3 months
measure: Patient satisfaction with general care and the study intervention
timeFrame: 6 months
measure: Psychiatric outcome on the Patient Health Questionnaire
timeFrame: 6 months
measure: Fatigue on CIS-fatigue scale
timeFrame: 6 months
Other outcomes:
measure: Adverse events
timeFrame: 6 months
Locations:
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
Study officials:
affiliation: University Medical Center Groningen, University of Groningen
name: Marina Tijssen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sharpe M, Walker J, Williams C, Stone J, Cavanagh J, Murray G, Butcher I, Duncan R, Smith S, Carson A. Guided self-help for functional (psychogenic) symptoms: a randomized controlled efficacy trial. Neurology. 2011 Aug 9;77(6):564-72. doi: 10.1212/WNL.0b013e318228c0c7. Epub 2011 Jul 27.
citation: Lehn A, Gelauff J, Hoeritzauer I, Ludwig L, McWhirter L, Williams S, Gardiner P, Carson A, Stone J. Functional neurological disorders: mechanisms and treatment. J Neurol. 2016 Mar;263(3):611-20. doi: 10.1007/s00415-015-7893-2. Epub 2015 Sep 26.
citation: Stone J, Carson A. Functional neurologic disorders. Continuum (Minneap Minn). 2015 Jun;21(3 Behavioral Neurology and Neuropsychiatry):818-37. doi: 10.1212/01.CON.0000466669.02477.45.
citation: Gelauff JM, Dreissen YE, Tijssen MA, Stone J. Treatment of functional motor disorders. Curr Treat Options Neurol. 2014 Apr;16(4):286. doi: 10.1007/s11940-014-0286-5.
citation: Gelauff JM, Rosmalen JGM, Carson A, Dijk JM, Ekkel M, Nielsen G, Stone J, Tijssen MAJ. Internet-based self-help randomized trial for motor functional neurologic disorder (SHIFT). Neurology. 2020 Sep 29;95(13):e1883-e1896. doi: 10.1212/WNL.0000000000010381. Epub 2020 Jul 20.