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PsychopathologyD-Psy adultesNCT05675215

External Validation by Machine Learning and Reduction of the Input Dimensions of the D-PSY Scale for Dimensional Psychopathology

An observational study of Psychopathology, run by Institut pour la Pratique et l'Innovation en PSYchologie appliquée (Institut Pi-Psy) at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Psychopathology
What is being tested?
Psychopathology screening tests
Type of treatment
Pill or oral medicine
How many people
200 participants
Where
1 siteFrance
Study dates
11 Oct 2022to 31 Mar 2023
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 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Study population: Normal adults with a suspicion of psychopathology

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

François Vialatte, PhD contact

+33 (0)1 69 44 96 60

contact@pi-psy.org

France1 site, 1 recruiting
  • Centre Pi-Psy de Draveil

    Draveil, Essonne, 91210

    François Vialatte, PhD, 0169449660, contact@pi-psy.org

    Aurore Vialatte, PhD

    Recruiting

Other trials in France

About this study

Official title: Validation Externe Par Apprentissage Statistique et réduction Des Dimensions d'entrée de l'échelle D-PSY

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.

Read the detailed description

This is a pilot study, in which 200 participants, aged 18-55 years, taken from the general population, with suspected psychopathology, will participate in screening consultations in which symptoms will be assessed with three different psychometric diagnostic tools. Their symptoms will be assessed using the French version of the SCID-5 (First et al., 2017), and the D-PSY screening procedure, including a self-reported questionnaire and semiological observations. Supplemental questionnaires will also be administered. The order in which these diagnostic tools will be administered will be randomized. Participants will be recruited in France, where the research will take place.

Doctors in the vicinity of the institute will be contacted and the study will be explained to them so that they can suggest eligible patients to participate. Advertising like posters presenting the study will also be put up in health care center and specialized websites. When a person agrees to participate in the study, they will be given an information letter about the protocol. After a delay of reflection, patients who agree to perform this research will be convened for an inclusion visit. After checking the inclusion/exclusion criteria, the letter of information will be completed and signed by the participant and duly countersigned by the investigator.

During this inclusion visit, a history will be taken in which demographic, psychiatric/medical data will be collected. Following this interview, the trained practitioner will complete his or her semiological observations of the patient.

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 SCID-5 interview will be conduct by a practitioner familiar with this interview and with the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5, American Psychiatric Association, 2013) classification and diagnostic criteria. Mental health practitioners administering the interviews will be blinded to the questionnaire scores.

The D-PSY questionnaire will be completed at the institute. A professional will explain how to complete the questionnaire if necessary and remain available in case of technical matters.

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)

This screening questionnaire has been created in order to measure quickly the most common mental health disorders and for the assessment of personality disorders. This new tool has been developed by the research team through a careful analysis of DSM-5 (American Psychiatric Association, 2013, Crocq et al., 2015) and CIM-11 (Mokaddem, et al., 2020) criteria for diagnosing mental health disorders, as well as criteria described in the SCID-5 (First et al., 2017) and the M.I.N.I (Sheehan et al., 1998). These are used respectively for the assessment of the 17 most common mental health disorders and for the assessment of personality disorders (as defined in the DSM-V, American Psychiatric Association, 2013).

After analysing the diagnostic and transdiagnostic criteria of the pathologies, the questions were carried out by focusing on one symptom and with the desire to create a continuum between two extremes of the symptom.

For example, the question "To what extent do you involve your relatives in your important decisions?" refers to autonomy and confidence in one's decisions. The extremes of the visual analogue scale are:

  1. "I am confident in my ability to make good decisions"
  2. "The opinion of my relatives is important to me". If a participant puts a response closer to the extreme (a), this will refer more to a narcissistic personality; whereas if he puts a response closer to the extreme (b), this will refer to a dependent personality.

The questions were developed in this way for all the pathologies present in the M.I.N.I. (Sheehan et al., 1998) and the SCID-5 (First et al., 2017) and some absent from it have been added: autism and specific phobia. Additional questions concerning transdiagnostic criteria were added, such as questions on dissociation and sleep.

The scale was constructed with the objective of reducing social desirability bias and confrontational questions. For this reason, we chose to use only positive terms or phrases that can be seen as positive or socially acceptable in the answers to the questions.

The semiological observations concern the elements identified in the speech of the participant and the observations that the practitioner makes during the interview. In the speech, the practitioner identifies whether the participant addresses somatic disorders (digestive, sensory, cardiac disorders, etc.), if he has psychic disorders (leakage of ideas, dissociation, delusions, etc.), if he addresses elements concerning his sleep (nocturnal awakenings, drowsiness, nightmares, etc.), elements concerning functional impairment (relationship difficulties, stress, etc.), whether he has mood disorders (dysphoria, euphoria, suicidal ideation) and if it addresses life events (positive such as encounters or opportunities or adverse such as bereavement, failure, accident). In terms of observations, the practitioner notes whether there is psychomotor impairment (agitation, inhibition, tics, etc.), a deterioration in dialogue (logorrhea, autistic withdrawal, etc.) and a deterioration in the relationship during the interview (provocation, resistance, seduction, etc.).

The semiological observations will be carried out by the practitioner during the inclusion visit. The latter will have to note the different clinical characteristics that he observes.

The SCID-5 (First, 2014) is a semi-structured interview in which the major DSM-5 diagnoses are assessed. This interview lasts approximately 45 to 90 minutes and will consist of a single interview.

This interview will be conducted by an experienced mental health practitioner familiar with the DSM-5 (American Psychiatric Association, 2013) classification and diagnostic criteria.

Each practitioner will be trained for the delivery of the SCID-5 (First et al., 2017) via the case studies and role plays included in the user guide provided by the authors.

Following this primary assessment phase including SCID 5 (First et al., 2017), the D-PSY questionnaire and the assessment of the semiological observations; other tests will be presented to the participants.

( a ) The French version of the Balanced Inventory of Desirable Responding (BIDR, Paulhus, 1985, 1991; in French: Cournoyer \& Sabourin, 1991) is 40-item self-report measuring deliberate and nondelibarate socially desirable response style.

( b ) The dissociation questionnaire (DIS-Q, Vanderlinden et al., 1993) is a self-report instrument of dissociation symptoms. Four subscales exist: 1) identity confusion; 2) loss of control over behaviour, thoughts and emotion; 3) amnesia; and 4) absorption. We used the French version (Mihaescu et al., 1998).

( c ) The French version of the Brief standard self-rating for phobic patient or "the fear questionnaire" (F.Q., Marks \& Mathews, 1979; in French Cottraux et al, 1987) is a 24-item self-report composed of three parts. The first part measure global phobia including agoraphobia, blood and injury phobia, and social phobia; the second part measure anxiety-depression and the third one the consequences of this behaviour. It yields four scores: main phobia, global phobia, total phobia and anxiety-depression.

( d )The Autism Spectrum quotient (AQ ; Baron-Cohen et al., 2001; in French, translation by Braun \& Kempenaers, 2007) is a diagnostic self-report measuring the expression of Autism-Spectrum traits.

Statistical learning will be used to build a predictive model, separating the data to build an independent test base. The main objective of this investigation is to predict the majority of SCID-5 pathologies (validity test) with a success rate significantly higher than chance.

The secondary objectives of this investigation are:

  • To extract a dimensional structure of pathologies
  • To resolve the social desirability bias present in current questionnaires by using positive terms.
  • To make the questionnaire easy to use (speed, feasibility, constraints)
  • To set up an emotionally non-confronting questionnaire
Conditions
Psychopathology
Being tested
Psychopathology screening tests

What participants receive

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

  • Psychopathology screening testsDiagnostic test

    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).

Study groups in NCT05675215
Study groupRoleWhat they receive
Normal subjects with suspicion of psychopathological disorderAdults 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.
Receives: Diagnostic Test: Psychopathology screening tests

What is being measured

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

  1. Prediction of SCID-5

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

    Measured: 1 year

Secondary outcomes (4)
  1. Dimensional structure of psychopathologies

    Extract a dimensional structure of psychopathologies

    Measured: 2 years

  2. Desirability bias

    Resolve the social desirability bias present in current questionnaires by using positive terms

    Measured: 18 monthes

  3. Ease-of-use

    Allow for ease of use of the questionnaire (speed, feasibility, constraints)

    Measured: 18 monthes

  4. Non-confrontational questionnaire

    Implement an emotionally non-confrontational questionnaire

    Measured: 18 monthes

Timeline

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

  1. First posted9 Jan 2023
  2. Study start11 Oct 2022
  3. Primary completion31 Mar 2023 (estimated)
  4. Study completion31 Mar 2023 (estimated)

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
Other
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05675215
Sponsor's protocol ID
2022-A00076-37
Acronym
D-Psy adultes
Status last verified
Dec 2022
First submitted
29 Dec 2022
Last updated
9 Jan 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: No sharing plan

Questions about this trial

What is this clinical trial studying?

An observational study of Psychopathology, run by Institut pour la Pratique et l'Innovation en PSYchologie appliquée (Institut Pi-Psy) 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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 9 Jan 2023. 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?

Results are not available in the source record.

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

Contact François Vialatte, PhD (+33 (0)1 69 44 96 60, contact@pi-psy.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prediction of SCID-5 (time frame: 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 9 Jan 2023.

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