AzTrials
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Functional Movement DisorderSCHEMAFNCT03717376

Movement Disorders and Early Maladaptive Schemas

An observational study of Functional Movement Disorder and Parkinson Disease, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

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

Functional neurological disorders (FND) are neurological symptoms that cannot be explained by a lesion or related to an identified dysfunction of the central nervous system. FND are under-diagnosed, although common and highly disabling. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Self-questionnaire YSQ-S3 (Young Schema Questionnaire)
How many people
80 participants
Where
1 siteFrance
Study dates
12 Feb 2019to 12 Feb 2020
Phase
Observational
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

Study population: Patients followed-up at Pitié-Salpêtrière hospital with functional movement disorder, parkinson's disease or distonic disorders.

Who may be able to join

  • Age ≥ 18 years-old
  • Being diagnosed with Parkinson's Disease (United Kingdom Parkinson's Disease Society Brain Bank (UKPDSBB) criteria) or with Functional Movement Disorder (Gupta \& Lang criteria) or with Dystonia (criteria from Obeso et al. Mov Dis 2013)
  • Being previously included in the research protocol untitled " Retentissement des mouvements anormaux "
  • Patient informed and having given their non-opposition
  • Written and oral comprehension of French

Who cannot join

  • Pregnancy
  • Guardianship or Tutelage measure
  • Psychosis
  • Other neurological disorder (i.e.: brain tumor, ...)

Trial locations and contacts

1 site in 1 country.

France1 site
  • APHP - Pitié-Salpêtrière hospital

    Paris, 75013

Other trials in France

About this study

Official title: Specificity of Early Maladaptive Schemas in Functional Movement Disorders

Functional neurological disorders (FND) are neurological symptoms that cannot be explained by a lesion or related to an identified dysfunction of the central nervous system. FND are under-diagnosed, although common and highly disabling. Childhood trauma events are found in 30% to 80% of FND patients, and are more common in people with functional neurological disorder than in healthy controls and patient controls. Overall, risks factors, perpetuating factors and maintaining factors have been described in FND, although none of the studies have analysed the prevalence of Early Maladaptive Schemas (EMS) in these patients. EMS, as measured with the Young Schema Questionnaire (YSQ), are proposed to underlie a variety of mental health problems, in particular Personality Disorders. We hypothesize that some of these early maladaptive schemas may participate in the psychopathology and severity of FND.

The main outcome of this study is to assess the prevalence of early maladaptive schemas in patients presenting with Functional Movement Disorders in comparison to patients presenting with Parkinson's Disease or Organic Dystonia. The secondary outcomes are to further analyse the underlying relation of these early maladaptive schemas and (i) the severity of the motor symptoms, (ii) anxiety and/or depression, (iii) the occurrence of childhood trauma events in our participants.

Read the detailed description

Functional neurological disorders (FND) are neurological symptoms that cannot be explained by a lesion or related to an identified dysfunction of the central nervous system. FND are under-diagnosed, although common and highly disabling. Functional Movement Disorders are a sub-category of FND, affecting the voluntary motor command. Childhood trauma events are found in 30% to 80% of FND patients, and are more common in people with functional neurological disorder than in healthy controls and patient controls. Overall, risks factors, perpetuating factors and maintaining factors have been described in FND, and some team research as Brown R. and al. have attempted to include it in psychopathological models such as the Integrative Conceptual Model in 2004. Nonetheless, none of the studies have analysed the prevalence of Early Maladaptive Schemas (EMS) in these patients. EMS, as measured with the Young Schema Questionnaire (YSQ), are proposed to underlie a variety of mental health problems, in particular Personality Disorders. Jeffrey Young has developed this concept in the 90's, through the so called "Schema Therapy". EMS are proposed as the core and main target for treatment of personality disorders and long-standing characterological problems. The current definition of an EMS is "a broad, pervasive theme or pattern, comprised of memories, emotions, cognitions, and bodily sensations, regarding oneself and one's relationships with others, developed during childhood or adolescence, elaborated throughout one's lifetime and dysfunctional to a significant degree". It has been studied in various conditions such as obesity, personality disorders, post-traumatic stress disorder, or obsessive-compulsive disorder, finding some EMS specificity in patients presenting with these conditions. In our study, we hypothesize that some of these early maladaptive schemas may participate in the psychopathology and severity of FND.

The main outcome of this study is to assess the prevalence of early maladaptive schemas in patients presenting with Functional Movement Disorders in comparison to patients presenting with Parkinson's Disease or Organic Dystonia. The secondary outcomes are to further analyse the underlying relation of these early maladaptive schemas and (i) the severity of the motor symptoms, (ii) anxiety and/or depression, (iii) the occurrence of childhood trauma events in our participants.

In order to reach these objectives, we aim to include 77 patients from which 30 patients with Functional Movement Disorder, 28 patients with Parkinson's disease, 19 patients with organic dystonia.

All eligible participants who have accepted to participate in the study will fill the YSQ-S3 (Short Form, French Version, validated and reliable instrument in clinical and research settings).The YSQ-S3 is a self-questionnaire which uses a Likert-type ranking, whereby 1 means "completely untrue of me" and 6 means "describes me perfectly". Similarly, questions range from life experiences to present feelings about certain situations. It consists of 90 self-report items, measuring all of the 18 EMS, aiming to describe one's functioning schemas over the past year.

Being tested
Self-questionnaire YSQ-S3 (Young Schema Questionnaire)
Keywords
Functional Movement Disorder, Functional Neurological Disorder, Early Maladaptive Scheme, Parkinson, Dystonia
Medical subject headings
Conversion Disorder, Parkinson Disease, Dystonic Disorders, Dystonia

What participants receive

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

  • Self-questionnaire YSQ-S3 (Young Schema Questionnaire)Other

    All participants will fill the YSQ-S3 at home and send it back to the main investigator.

What is being measured

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

  1. Assessment of the prevalence of early maladaptive schemas in patients with Functional Movement Disorders versus patients with Parkinson's Disease or Dystonic Disorders

    Score ≥16 in each schema on the Young Schema Questionnaire-S3 (YSQ-S3) is considered as pathological

    Measured: Through study completion, an average of 1 year

Secondary outcomes (3)
  1. Correlation between the YSQ-S3 scores and the severity of motor symptoms (score from the Unified Parkinson's Disease Rating Scale (UPDRS) part 3)

    Clinical Severity score on UPDRS part 3 ranges from 0 (none) to 108 (severe)

    Measured: Through study completion, an average of 1 year

  2. Correlation between the YSQ-S3 scores and anxiety/depression symptoms (screened with the Hospital Anxiety and Depression Scale (HADS) together with the Mini International Neuropsychiatric Interview (MINI))

    Presence of anxiety if HADS-Anxiety ≥10; Presence of depression if HADS-Depression ≥10

    Measured: Through study completion, an average of 1 year

  3. Correlation between the YSQ-S3 scores and self-reported childhood traumatic events (assessed with the Composite International Diagnosis Interview (CIDI) questionnaire)

    Assessment of the different types of childhood trauma events

    Measured: Through study completion, an average of 1 year

Timeline

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

  1. First posted24 Oct 2018
  2. Study start12 Feb 2019
  3. Primary completion12 Feb 2019
  4. Study completion12 Feb 2020

Resources

More details

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

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03717376
Sponsor's protocol ID
NI18039J
Acronym
SCHEMAF
Status last verified
Feb 2021
First submitted
15 Oct 2018
Last updated
31 Jan 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Functional Movement Disorder and Parkinson Disease, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

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 5 inclusion and 4 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 31 Jan 2022. 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 France. 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?

Assessment of the prevalence of early maladaptive schemas in patients with Functional Movement Disorders versus patients with Parkinson's Disease or Dystonic Disorders (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 31 Jan 2022.

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