Self-help and Education on the Internet for Functional Motor Disorders

Functional Motor Disorder Clinical Trial

— SHIFT  

Official title:

Self-Help and Education on the Internet for Functional Motor Disorders, a Randomised Controlled Trial (SHIFT)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02589886
• Other study ID #: METc/2015/141
• Status: Completed
• Phase: N/A
• Start date: October 2015
• Est. completion date: December 2018

Study information

• Verified date: January 2019
• Source: University Medical Center Groningen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 189
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Disease
• Functional Motor Disorder
• Motor Disorders

Intervention

Other:
• Education and self-help internet intervention
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.

Locations

Country	Name	City	State
Netherlands	University Medical Center Groningen	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

References & Publications (4)

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. — View 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. Review. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse events	Death and hospitalization during the trial	6 months
Primary	Subjective general health Status on the Clinical Global Improvement scale	CGI, self-rated, 7-point scale of general health status	3 months
Primary	Subjective general health Status on the Clinical Global Improvement scale	CGI self-rated, 7-point scale of general health status	6 months
Secondary	Quality of life on domains of RAND-36	extra question added to RAND-36 from WHOQuality Of Life scale	3 months
Secondary	Quality of life on domains of RAND-36	extra question added to RAND-36 from WHO-Quality Of Life scale	6 months
Secondary	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	3 months
Secondary	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	6 months
Secondary	Referral and other treatments on a questionnaire about referral and other treatments	Questions about future and past referrals to treatment	6 months
Secondary	Symptom severity on the change in presenting symptoms scale		3 months
Secondary	Symptom severity on the change in presenting symptoms scale		6 months
Secondary	Work and social adjustment	Work and Social Adjustment scale	6 months
Secondary	Cost-effectivity in QALY's calculated by using the PCQ, MCQ and EQ5D	Analysis using: Patient Costs Questionnaire, Medical Costs Questionnaire, and EQ5D	6 months
Secondary	Patient satisfaction with general care and the study intervention	Questions on satisfaction with general care and with the education and selfhelp intervention in particular	3 months
Secondary	Patient satisfaction with general care and the study intervention	Questions on satisfaction with general care and with the education and selfhelp intervention in particular	6 months
Secondary	Psychiatric outcome on the Patient Health Questionnaire		6 months
Secondary	Fatigue on CIS-fatigue scale		6 months