NCT05675215

Brief Summary

There have been debates about whether psychiatric disorders should be classified according to categories (categorical model) or according to a continuum between normal and pathological functioning (dimensional model). While the former is the main one used to facilitate reliability, it has several limitations. We will use machine learning to develop a predictive model, bridging the gap between the dimensional and categorical approaches. Psychometric measures obtained from a questionnaire will be collected. Then, a supervised descriptor selection approach will be applied to predict categorical outcomes from dimensional inputs. The resulting prediction will be based on nonlinear modeling based on universal approximators. We developed this input questionnaire with four main objectives: 1) to briefly scan most of the categories generally described in the international nosography; 2) to use a continuous scale following a dimensional approach; 3) to use positively oriented sentences to decrease social desirability bias; 4) to be less confronting for the patient. The questionnaire is built on dimensions, whereas psychiatric diagnoses are built on categories. We will model the transition from one to the other. This approach will allow us to verify the hypotheses of diagnostic categories construction in psychopathology, integrated in the RDoC approach; and later on to standardize the psychometric measures used in cognitive-behavioral therapy treatments. 200 adults will undergo a standard clinical interview (SCID-5, First et al., 2017), and the psychological screening self-report questionnaire (D-Psy) and additional questionnaires measuring social desirability dissociation, phobia and autism.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 11, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 29, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 9, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2023

Completed
Last Updated

January 9, 2023

Status Verified

December 1, 2022

Enrollment Period

6 months

First QC Date

December 29, 2022

Last Update Submit

December 29, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Prediction of SCID-5

    Predict the majority of SCID-5 pathologies (validity test) with a success rate significantly higher than chance.

    1 year

Secondary Outcomes (4)

  • Dimensional structure of psychopathologies

    2 years

  • Desirability bias

    18 monthes

  • Ease-of-use

    18 monthes

  • Non-confrontational questionnaire

    18 monthes

Study Arms (1)

Normal subjects with suspicion of psychopathological disorder

Adults over 18 years old who are fluent in French (oral and written). Participant with neurological or organic mental disorder (not induced by substances) including dementia, organic amnesic syndrome, delirium, other mental, personality or behavioural disorders due to brain damage, dysfunction or to physical disease.

Diagnostic Test: Psychopathology screening tests

Interventions

The assessment phase includes the SCID-5 (First et al., 2017), the D-PSY questionnaire and standardized questionnaires. The D-PSY questionnaire and the SCID-5 (First et al., 2017) will be counterbalanced in terms of the order of administration, with half of the participants taking the SCID-5 (First et al., 2017) first and then the D-PSY questionnaire and the others standardized; the other half will take the D-PSY first and then the SCID-5 (First et al., 2017) and the other questionnaires. The other standardised questionnaires will be randomised for order of administration. These standardised questionnaires measure social desirability (Balanced Inventory of Desirable Responding, BIDR, Paulhus, 1985, 1991; in French: Cournoyer \& Sabourin, 1991), dissociation (DIS-Q, Vanderlinden et al., 1993), phobia (the Fear Questionnaire, F.Q., Marks \& Mathews, 1979; in French Cottraux et al., 1987) and autism (AQ, Baron-Cohen et al., 2001; in French, translation by Braun \& Kempenaers, 2007).

Normal subjects with suspicion of psychopathological disorder

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Normal adults with a suspicion of psychopathology

You may qualify if:

  • Adults over 18 years old and less than 65 years old who are fluent in French (oral and written), with suspicions of psychopathology.
  • Protected adults and pregnant women cannot participate.

You may not qualify if:

  • Participant with neurological or organic mental disorder (not induced by substances) including dementia, organic amnesic syndrome, delirium;
  • other mental, personality or behavioural disorders due to brain damage, dysfunction or to physical disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Pi-Psy de Draveil

Draveil, Essonne, 91210, France

RECRUITING

Study Officials

  • Aurore Vialatte, PhD

    Institut pour la Pratique et l'Innovation en PSYchologie appliquée (Institut Pi-Psy)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

François Vialatte, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 29, 2022

First Posted

January 9, 2023

Study Start

October 11, 2022

Primary Completion

March 31, 2023

Study Completion

March 31, 2023

Last Updated

January 9, 2023

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

No sharing plan

Locations