- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06691295
Exploring Transdiagnostic Psychological Processes in Functional Neurological Disorder (Process-TNF)
Functional neurological disorder (FND) is a little-known borderline disorder between psychiatry and neurology, which is benefiting from renewed research. Characterized by neurological symptoms in the absence of lesion damage corresponding to the symptom, the disorder is thought to be due to functional impairment of the central nervous system (DSM5 American Psychiatric Association, 2013). Symptoms are non-congruent, discordant and inconsistent with current anatomical knowledge. Several phenotypes are listed and may be associated: among the most frequent are motor and sensory disorders and dissociative crises or seizures.
Common (Carson & Lehn, 2016) and disabling (Gendre et al., 2019), the neurobiological and psychological mechanisms involved in NFT are becoming better understood, yet its etiology remains enigmatic (Hallett et al., 2022). Recent theoretical models consider neuropsychological constructs as central to the development and maintenance of the disorder, influenced by emotional processes (Drane et al., 2020).
With a reputation for being difficult to treat, FND is a clinical challenge, and cognitive-behavioural therapy (CBT), although advocated, shows limits of efficacy mainly due to the complexity of clinical pictures and the heterogeneity of profiles (Gutkin et al., 2021). The CBTs described for FND are not specific to the disorder, and do not appear to be developed around a general theoretical framework defining the psychological mechanisms of the disorder (Richardson et al., 2020).
Thus, there would be an interest in identifying characteristics in these patients that could guide therapeutic choices and implement a better therapeutic response (Gutkin et al., 2021). These findings, coupled with the growing interest in this complex disorder, confirm the need to deepen our knowledge of the psychological mechanisms involved in the disorder, with a view to developing and testing a specialized and flexible clinic (Aybek et al., 2020).
Given the complexity of the disorder, a transdiagnostic approach is suggested (Saxena & Perez, 2021). The transdiagnostic processual approach (Harvey et al., 2004) proposes an innovative conceptualization of mental health problems. This model sees the human biological system as leading to psychological disorder through the disruption of initially normal psychological processes (Kinderman, 2005). These processes refer to psychological mechanisms on which the clinician can act, via validated therapeutic strategies. Transdiagnostic treatments apply the same underlying treatment principles to all mental disorders, without tailoring the protocol to specific diagnoses (Menon et al., 2017).
Considering the psychological mechanisms described as being altered in the disorder, etiological hypotheses, and literature data concerning transdiagnostic psychological processes, we raise the question of the involvement of such processes in FND. The aim of this study is to explore these processes in an FND population, with a view to refining our understanding of the psychological profile of these patients and guiding treatment.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Bron, France, 69500
- Hôpital Pierre Wertheimer
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria * :
- Subjects diagnosed with FND by a neurologist ("Conversion disorder (disorder with functional neurological symptomatology" in DSM5)) from neurological report
- Subject presenting one of the main phenotypes, i.e. 1. sensitivo-motor, 2. seizure / malaise (CNEP) as indicated by neurological report
- Prior to any psychological, psychiatric or rehabilitative treatment for this TNF
- Subject able to receive information and not to object to the use of his/her data for research purposes
Exclusion Criteria * :
- Subjects with symptoms corresponding to a pure pain or cognitive phenotype - patient's medical record
- Subject with cognitive disorders - Moca score < 18
- Subjects with diagnosed psychiatric comorbidities according to psychiatric CR + HADS scores A > 11 and D > 11
- Subjects with neurological comorbidities - according to neurologist's CR
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Patients with functional neurological disorders.
This study focuses on adult subjects with newly diagnosed functional neurological disorders (less than 5 years old) and prior to therapeutic management.
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This study aims to explore transdiagnostic psychological processes (PP) via the administration of self-reported scales and questionnaires, in a population of newly diagnosed FND patients, prior to any therapeutic management. The main objective is to describe the psychometric properties (scores on tools measuring psychological processes) of NFT patients (presenting the main phenotypes; sensitivo-motor; and seizures and discomfort). |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Uncertainty Intolerance Scale - II
Time Frame: Data collected from May to July 2024 at the time of patient integration into the specialized FND care pathway.
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Scores on the Uncertainty Intolerance Scale - II to assess intolerance of uncertainty.
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Data collected from May to July 2024 at the time of patient integration into the specialized FND care pathway.
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Metacognitive Belief Questionnaire - MCQ-30
Time Frame: Data collected from May to July 2024 at the time of patient integration into the specialized FND care pathway.
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Scores on the Metacognitive Belief Questionnaire - MCQ-30 to assess metacognitive beliefs.
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Data collected from May to July 2024 at the time of patient integration into the specialized FND care pathway.
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Ruminations Scale - Mini-CERTS
Time Frame: Data collected from May to July 2024 at the time of patient integration into the specialized FND care pathway.
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Scores on the Ruminations Scale - Mini-CERTS to assess ruminative thinking patterns.
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Data collected from May to July 2024 at the time of patient integration into the specialized FND care pathway.
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Experiential Avoidance Questionnaire - MEAQ-short
Time Frame: Data collected from May to July 2024 at the time of patient integration into the specialized FND care pathway.
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Scores on the Experiential Avoidance Questionnaire - MEAQ-short to assess experiential avoidance.
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Data collected from May to July 2024 at the time of patient integration into the specialized FND care pathway.
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Personalized Psychological Flexibility Index - PPFI
Time Frame: Data collected from May to July 2024 at the time of patient integration into the specialized FND care pathway.
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Scores on the Personalized Psychological Flexibility Index - PPFI to assess psychological flexibility.
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Data collected from May to July 2024 at the time of patient integration into the specialized FND care pathway.
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Emotional Regulation Scale - DERS-F
Time Frame: Data collected from May to July 2024 at the time of patient integration into the specialized FND care pathway.
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Scores on the Emotional Regulation Scale - DERS-F to assess emotional regulation.
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Data collected from May to July 2024 at the time of patient integration into the specialized FND care pathway.
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Somatoform Dissociation Questionnaire - SDQ-20
Time Frame: Data collected from May to July 2024 at the time of patient integration into the specialized FND care pathway.
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Scores on the Somatoform Dissociation Questionnaire - SDQ-20 to assess somatoform dissociation.
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Data collected from May to July 2024 at the time of patient integration into the specialized FND care pathway.
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Short Form Health Survey - SF-36
Time Frame: Data collected from May to July 2024 at the time of patient integration into the specialized FND care pathway.
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Scores on the Short Form Health Survey - SF-36 to assess general health and quality of life.
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Data collected from May to July 2024 at the time of patient integration into the specialized FND care pathway.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: BOUAMMARI Annablle, Neurologie inflammatoire Hôpital P. Wertheimer/GHE
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 23-5173
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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