Clinical trial NCT04481217: Cognitive Factors Mediating the Relationship Between Childhood Trauma and Auditory Hallucinations in Schizophrenia
Official title: The Mediating Role of Dissociative Symptoms and Early Maladaptive Schemas in the Relationship Between Childhood Trauma and Auditory Hallucinations in Schizophrenia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Schizophrenia
Keywords: schizophrenia
auditory verbal hallucinations
early maladaptive schemas
dissociative symptoms
childhood traumas
mediation modeling
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2020-07-22
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: BACKGROUND It is demonstrated that strong associations between trauma suffered in childhood and having schizophrenia, and more specifically to experience acoustic-verbal hallucinations (AVH). A second generation of research is currently examining the cognitive and affective processes likely to play a mediating role in this association. These mediators appear to include early maladaptive personality patterns and dissociative experiences. Although these factors have most often been explored separately, recent research indicates that they could be associated, and thus contribute to AVH. More specifically, another study has shown that the association between childhood trauma and predisposition to AVH is not direct but depends on cognitive factors including the impact of violence suffered during childhood on early maladaptive schemas and dissociation. However, this study was carried out on a non-clinical sample of subjects with a predisposition to AVH.

OBJECTIVES: testing a structural model of AVH, childhood trauma, early maladaptive schemas and dissociative symptoms in large multicentric sample of inpatients diagnosed with schizophrenia and AVH (n=350). Secondary objectives are (i) test in the model the role of all the early patterns described by Jeffrey Young instead of targeting only the schemes that are part of the model tested in previous study as the one by Bortolon and colleagues, (ii) compare the quality of the adjustment of the confirmatory model to the quality of the adjustment of the exploratory model.

METHODS: one single visit in which subjects will receive self-reported questionnaires (Childhood trauma questionnaire, The Young schema questionnaire short form, Dissociative experiences scale, Launay-Slade hallucination scale and Cardiff Anomalous Perceptions Scale.

ANALYSES: Structural equation model performed additional analysis using Partial Least Squares Structural Equation Modelling. The primary endpoint corresponds to significant associations between the variables. The quality of the model will be assessed using a fit quality measure. The secondary endpoints are significant associations between the different variables (p \<0.05) and the model quality assessed with a quality measure of the fit.

MAIN HYPOTHESIS: the association between childhood trauma and predisposition to AVH is not direct, but depends on the impact of violence suffered during childhood on early maladaptive schemas and dissociative symptoms in patients with schizophrenia.

Detailed description: BACKGROUND A first generation of research has demonstrated strong associations between trauma suffered in childhood (physical, psychological and sexual violence) and having schizophrenia, and more specifically to experience "hearing voices" (acoustic-verbal hallucinations, AVH).

A second generation of research is currently examining the cognitive and affective processes likely to play a mediating role in this association. These mediators appear to include early maladaptive personality patterns and dissociative experiences. Although these factors have most often been explored separately, recent research indicates that they could be associated, and thus contribute to AVH. More specifically, another study has shown that the association between childhood trauma and predisposition to AVH is not direct but depends on cognitive factors including the impact of violence suffered during childhood on early maladaptive schemas (for example, interpersonal functioning centred on "subjugation", "abandonment", "vulnerability") and dissociation. However, this study was carried out on a non-clinical sample of subjects with a predisposition to AVH OBJECTIVES Here, aim is at testing a structural model of AVH, childhood trauma, early maladaptive schemas and dissociative symptoms in large sample of patients diagnosed with schizophrenia and AVH (n=350).

Secondary objectives are (i) to carry out exploratory analyzes which will allow investigators to test in the model the role of all the early patterns described by Jeffrey Young instead of targeting only the schemes that are part of the model tested in previous study as the one by Bortolon and colleagues, (ii) compare the quality of the adjustment of the confirmatory model to the quality of the adjustment of the exploratory model.

METHODS

A cross-sectional, multicenter design (3 centres) will be performed. Patients included will be diagnosed with schizophrenia or schizoaffective disorder, and experience AVH at the time of the inclusion (n= 350). All will be inpatients. The study consists of one single visit in which the subjects will receive all the self-reported questionnaires to be completed:

1. General information sheet (socio-demographic and clinical data)
2. Questionnaire on traumatic childhood experiences: Childhood trauma questionnaire
3. Questionnaire on early maladaptive schemas: The Young schema questionnaire short form
4. Questionnaire about dissociative experiences: Dissociative experiences scale
5. Questionnaire on hallucinations: Launay - Slade hallucination scale and Cardiff Anomalous Perceptions Scale.

All questionnaires have been validated in French. ANALYSES Structural equation model performed additional analysis using Partial Least Squares Structural Equation Modelling (PLS-SEM).

The primary endpoint corresponds to significant associations (significance threshold \<0.05) between the variables as in the model described by Bortolon and colleagues. The quality of the model (both measurement and structural model) will be assessed using a fit quality measure.

The secondary endpoints are significant associations between the different variables (p \<0.05) and the model quality assessed with a quality measure of the fit.

HYPOTHESES It's hypothesized that the association between childhood trauma and predisposition to AVH is not direct, but depends on the impact of violence suffered during childhood on early maladaptive schemas (for example, interpersonal functioning centred on "subjugation", "abandonment", "vulnerability") and dissociative symptoms in patients with schizophrenia.

Eligibility criteria: Inclusion criteria:

* Schizophrenia or schizo-affective disorder
* Auditory hallucinations
* Fluent in French
* Gave informed consent

Exclusion Criteria:

* Agitation or suicide risk
* Involuntary Hospitalization
* Neurologic condition
* No informed consent

Primary outcomes:
measure: Auditory hallucinations measured by the Launay-Slade Hallucination Scale
timeFrame: Baseline
Secondary outcomes:
measure: Defensive dissociation assessed by the Dissociative experiences scale (DES)
timeFrame: Baseline
measure: Early maladaptive schema "Abandonment", which is measured by the young schema questionnaire short form (SQ-SF)
timeFrame: Baseline
measure: The early maladaptive schema "Self-sacrifice", which is measured by the young schema questionnaire short form (SQ-SF)
timeFrame: Baseline
measure: The early maladaptive schema "Vulnerability", which is measured by the young schema questionnaire short form (SQ-SF)
timeFrame: Baseline
measure: The early maladaptive schema "Subjugation", which is measured by the young schema questionnaire short form (SQ-SF)
timeFrame: Baseline
Other outcomes:
Locations:
city: La Tronche
country: France
facility: Grenoble University Hospital
city: Saint-Étienne
country: France
facility: Chu St Etienne
Study officials:
affiliation: CHU Grenoble Alpes
name: Clément DONDE
role: PRINCIPAL_INVESTIGATOR
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