Movement Disorders and Early Maladaptive Schemas (SCHEMAF)

January 28, 2022 updated by: Assistance Publique - Hôpitaux de Paris

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.

Study Overview

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.

Study Type

Observational

Enrollment (Actual)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Paris, France, 75013
        • APHP - Pitié-Salpêtrière Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  1. Age ≥ 18 years-old
  2. 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)
  3. Being previously included in the research protocol untitled " Retentissement des mouvements anormaux "
  4. Patient informed and having given their non-opposition
  5. Written and oral comprehension of French

Exclusion Criteria:

  1. Pregnancy
  2. Guardianship or Tutelage measure
  3. Psychosis
  4. Other neurological disorder (i.e.: brain tumor, ...)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Score ≥16 in each schema on the Young Schema Questionnaire-S3 (YSQ-S3) is considered as pathological
Through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between the YSQ-S3 scores and the severity of motor symptoms (score from the Unified Parkinson's Disease Rating Scale (UPDRS) part 3)
Time Frame: Through study completion, an average of 1 year
Clinical Severity score on UPDRS part 3 ranges from 0 (none) to 108 (severe)
Through study completion, an average of 1 year
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))
Time Frame: Through study completion, an average of 1 year
Presence of anxiety if HADS-Anxiety ≥10; Presence of depression if HADS-Depression ≥10
Through study completion, an average of 1 year
Correlation between the YSQ-S3 scores and self-reported childhood traumatic events (assessed with the Composite International Diagnosis Interview (CIDI) questionnaire)
Time Frame: Through study completion, an average of 1 year
Assessment of the different types of childhood trauma events
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Richard LEVY, MD. PhD, Assistance Publique Hoptiaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 12, 2019

Primary Completion (Actual)

February 12, 2019

Study Completion (Actual)

February 12, 2020

Study Registration Dates

First Submitted

October 15, 2018

First Submitted That Met QC Criteria

October 22, 2018

First Posted (Actual)

October 24, 2018

Study Record Updates

Last Update Posted (Actual)

January 31, 2022

Last Update Submitted That Met QC Criteria

January 28, 2022

Last Verified

February 1, 2021

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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