NCT02589886

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
189

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

October 2, 2015

Completed
26 days until next milestone

First Posted

Study publicly available on registry

October 28, 2015

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

January 29, 2019

Status Verified

January 1, 2019

Enrollment Period

3.2 years

First QC Date

October 2, 2015

Last Update Submit

January 28, 2019

Conditions

Functional Motor Disorder

Keywords

Self-helpEducatione-Health

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (13)

  • Quality of life on domains of RAND-36

    3 months

  • Quality of life on domains of RAND-36

    6 months

  • Illness beliefs on the Illness Perception Questionnaire

    3 months

  • Illness beliefs on the Illness Perception Questionnaire

    6 months

  • Referral and other treatments on a questionnaire about referral and other treatments

    6 months

  • +8 more secondary outcomes

Other Outcomes (1)

  • Adverse events

    6 months

Study Arms (2)

intervention

ACTIVE COMPARATOR

This arm will receive the education and self-help internet intervention added to usual care

Other: Education and self-help internet intervention

control

NO INTERVENTION

This arm will receive usual care only

Interventions

Education and self-help internet interventionOTHER

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.

intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Groningen

Groningen, 9700 RB, Netherlands

Location

Related Publications (5)

  • 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.

    PMID: 21795652BACKGROUND

  • 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.

    PMID: 26410744BACKGROUND

  • 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.

    PMID: 26039857BACKGROUND

  • 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.

    PMID: 24566832BACKGROUND

  • 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.

    PMID: 32690783DERIVED

MeSH Terms

Interventions

Educational Status

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Marina Tijssen, MD, PhD

    University Medical Center Groningen, University of Groningen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. de Koning-Tijssen

Study Record Dates

First Submitted

October 2, 2015

First Posted

October 28, 2015

Study Start

October 1, 2015

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

January 29, 2019

Record last verified: 2019-01

Locations

NL(1)