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

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.

Study Overview

• Status: Completed
• Conditions: Functional Motor Disorder
• Intervention / Treatment: Other: Education and self-help internet intervention

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).

• Study Type: Interventional
• Enrollment (Actual): 189
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Groningen, Netherlands, 9700 RB
    • University Medical Center Groningen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: intervention; This arm will receive the education and self-help internet intervention added to usual care	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.
No Intervention: control; This arm will receive usual care only

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective general health Status on the Clinical Global Improvement scale	CGI, self-rated, 7-point scale of general health status	3 months
Subjective general health Status on the Clinical Global Improvement scale	CGI self-rated, 7-point scale of general health status	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life on domains of RAND-36	extra question added to RAND-36 from WHOQuality Of Life scale	3 months
Quality of life on domains of RAND-36	extra question added to RAND-36 from WHO-Quality Of Life scale	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	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	6 months
Referral and other treatments on a questionnaire about referral and other treatments	Questions about future and past referrals to treatment	6 months
Symptom severity on the change in presenting symptoms scale		3 months
Symptom severity on the change in presenting symptoms scale		6 months
Work and social adjustment	Work and Social Adjustment scale	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	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	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	6 months
Psychiatric outcome on the Patient Health Questionnaire		6 months
Fatigue on CIS-fatigue scale		6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	Death and hospitalization during the trial	6 months

Collaborators and Investigators

• Sponsor: University Medical Center Groningen
• Investigators: Principal Investigator: Marina Tijssen, MD, PhD, University Medical Center Groningen, University of Groningen

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Actual): December 1, 2018
• Study Completion (Actual): December 1, 2018

Study Registration Dates

• First Submitted: October 2, 2015
• First Submitted That Met QC Criteria: October 26, 2015
• First Posted (Estimate): October 28, 2015

Study Record Updates

• Last Update Posted (Actual): January 29, 2019
• Last Update Submitted That Met QC Criteria: January 28, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Self-help; Education; e-Health
• Additional Relevant MeSH Terms: Mental Disorders; Motor Disorders
• Other Study ID Numbers: METc/2015/141

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED