Cognitive Factors Mediating the Relationship Between Childhood Trauma and Auditory Hallucinations in Schizophrenia

Study Overview
=================
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: General information sheet (socio-demographic and clinical data) Questionnaire on traumatic childhood experiences: Childhood trauma questionnaire Questionnaire on early maladaptive schemas: The Young schema questionnaire short form Questionnaire about dissociative experiences: Dissociative experiences scale 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.

Official Title
-----------------
The Mediating Role of Dissociative Symptoms and Early Maladaptive Schemas in the Relationship Between Childhood Trauma and Auditory Hallucinations in Schizophrenia

Conditions
-----------------
Schizophrenia

Intervention / Treatment
-----------------
* Other: Self-questionnaires battery
* Other: Socio-demographic screening


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Schizophrenia<br>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. | Other: Self-questionnaires battery<br>* Childhood trauma questionnaire (Bernstein, Ahluvalia, Pogge, & Handelsman, 1997; Bernstein et al., 2003) The Young schema questionnaire short form (SQ-SF ; Cottraux & Black, 2006; Young, 1998). Dissociative experiences scale (Laroi et al., 2013). Launay-Slade hallucination scale (Bentall & Slade, 1985; Launay & Slade, 1981) Cardiff Anomalous Perceptions Scale (Bell et al., 2006)<br>Other: Socio-demographic screening<br>* age; gender; education; highest diploma; job; marital status; living place<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Auditory hallucinations measured by the Launay-Slade Hallucination Scale | The auditory hallucinations measured by the Launay-Slade Hallucination Scale, which is a self-report scale developed to measure predisposition to hallucinations. Three items were designed to measure verbal hallucinations, which are measured using a 5-point Likert scale, from 0 to 4 (0 = definitely does not apply to me, 1 = possibly does not apply to me, 2 = unsure, 3 = possibly applies to me, and 4 = definitely applies to me). | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Defensive dissociation assessed by the Dissociative experiences scale (DES) | Defensive dissociation assessed by the Dissociative experiences scale (DES). The DES is a 28-item developed to measure dissociative experiences. Respondents are asked to rate how often they experienced each of the 28 described situation compared to other people. The scale was composed of 11 boxes that the participants had to tick (from much less than others to much more than others). | Baseline | 
| Early maladaptive schema Abandonment, which is measured by the young schema questionnaire short form (SQ-SF) | The early maladaptive schema Abandonment, which is measured by the young schema questionnaire short form (SQ-SF). The SQ-SF is a 75-item, self-report inventory designed to measure 15 EMS proposed by Young. Each item is rated on a 6-point scale (from 1 = completely untrue of me to 6 = describes me perfectly). Higher scores indicate a greater presence of a maladaptive schema for the respondent. | Baseline | 
| The early maladaptive schema Self-sacrifice, which is measured by the young schema questionnaire short form (SQ-SF) | The early maladaptive schema Self-sacrifice, which is measured by the young schema questionnaire short form (SQ-SF). The SQ-SF is a 75-item, self-report inventory designed to measure 15 EMS proposed by Young. Each item is rated on a 6-point scale (from 1 = completely untrue of me to 6 = describes me perfectly). Higher scores indicate a greater presence of a maladaptive schema for the respondent. | Baseline | 
| The early maladaptive schema Vulnerability, which is measured by the young schema questionnaire short form (SQ-SF) | The early maladaptive schema Vulnerability, which is measured by the young schema questionnaire short form (SQ-SF). The SQ-SF is a 75-item, self-report inventory designed to measure 15 EMS proposed by Young. Each item is rated on a 6-point scale (from 1 = completely untrue of me to 6 = describes me perfectly). Higher scores indicate a greater presence of a maladaptive schema for the respondent. | Baseline | 
| The early maladaptive schema Subjugation, which is measured by the young schema questionnaire short form (SQ-SF) | The early maladaptive schema Subjugation, which is measured by the young schema questionnaire short form (SQ-SF). The SQ-SF is a 75-item, self-report inventory designed to measure 15 EMS proposed by Young. Each item is rated on a 6-point scale (from 1 = completely untrue of me to 6 = describes me perfectly). Higher scores indicate a greater presence of a maladaptive schema for the respondent. | Baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
schizophrenia, auditory verbal hallucinations, early maladaptive schemas, dissociative symptoms, childhood traumas, mediation modeling