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Functional Motor DisorderSHIFTNCT02589886

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

A study testing Education and self-help internet intervention in people with Functional Motor Disorder, run by University Medical Center Groningen at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Functional Motor Disorder
What is being tested?
Education and self-help internet intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
189 participants
Where
1 siteNetherlands
Study dates
Oct 2015to Dec 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • University Medical Center Groningen

    Groningen, 9700 RB

Other trials in Netherlands

About this study

Official title: 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.

Read the 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).

Being tested
Education and self-help internet intervention
Keywords
Self-help, Education, e-Health

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT02589886
Study groupRoleWhat they receive
interventionActive comparatorThis arm will receive the education and self-help internet intervention added to usual care
Receives: Other: Education and self-help internet intervention
controlNo interventionThis arm will receive usual care only

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Subjective general health Status on the Clinical Global Improvement scale

    CGI, self-rated, 7-point scale of general health status

    Measured: 3 months

  2. Subjective general health Status on the Clinical Global Improvement scale

    CGI self-rated, 7-point scale of general health status

    Measured: 6 months

Secondary outcomes (13)

  1. Quality of life on domains of RAND-36

    extra question added to RAND-36 from WHOQuality Of Life scale

    Measured: 3 months

  2. Quality of life on domains of RAND-36

    extra question added to RAND-36 from WHO-Quality Of Life scale

    Measured: 6 months

  3. 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

    Measured: 3 months

  4. 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

    Measured: 6 months

  5. Referral and other treatments on a questionnaire about referral and other treatments

    Questions about future and past referrals to treatment

    Measured: 6 months

  6. Symptom severity on the change in presenting symptoms scale

    Measured: 3 months

  7. Symptom severity on the change in presenting symptoms scale

    Measured: 6 months

  8. Work and social adjustment

    Work and Social Adjustment scale

    Measured: 6 months

  9. Cost-effectivity in QALY's calculated by using the PCQ, MCQ and EQ5D

    Analysis using: Patient Costs Questionnaire, Medical Costs Questionnaire, and EQ5D

    Measured: 6 months

  10. Patient satisfaction with general care and the study intervention

    Questions on satisfaction with general care and with the education and selfhelp intervention in particular

    Measured: 3 months

  11. Patient satisfaction with general care and the study intervention

    Questions on satisfaction with general care and with the education and selfhelp intervention in particular

    Measured: 6 months

  12. Psychiatric outcome on the Patient Health Questionnaire

    Measured: 6 months

  13. Fatigue on CIS-fatigue scale

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Oct 2015 (estimated)
  2. Study startOct 2015
  3. Primary completionDec 2018
  4. Study completionDec 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
189 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02589886
Sponsor's protocol ID
METc/2015/141
Acronym
SHIFT
Status last verified
Jan 2019
First submitted
2 Oct 2015
Last updated
29 Jan 2019
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

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.

    PubMed 21795652

  • 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.

    PubMed 26410744

  • 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.

    PubMed 26039857

  • 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.

    PubMed 24566832

  • 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.

    PubMed 32690783

Questions about this trial

What is this clinical trial studying?

A study testing Education and self-help internet intervention in people with Functional Motor Disorder, run by University Medical Center Groningen at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Subjective general health Status on the Clinical Global Improvement scale (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02589886, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2019.

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