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

NCT04481217 | Unknown

• 2 other identifiers: 38RC20.0552020-A00452-37
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 2

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.

Conditions

Schizophrenia

Keywords

schizophrenia; auditory verbal hallucinations; early maladaptive schemas; dissociative symptoms; childhood traumas; mediation modeling

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Defensive dissociation assessed by the Dissociative experiences scale (DES)

  Baseline

• Early maladaptive schema "Abandonment", which is measured by the young schema questionnaire short form (SQ-SF)

  Baseline

• The early maladaptive schema "Self-sacrifice", which is measured by the young schema questionnaire short form (SQ-SF)

  Baseline

• The early maladaptive schema "Vulnerability", which is measured by the young schema questionnaire short form (SQ-SF)

  Baseline

• The early maladaptive schema "Subjugation", which is measured by the young schema questionnaire short form (SQ-SF)

  Baseline

Study Arms (1)

Schizophrenia

EXPERIMENTAL

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; Other: Socio-demographic screening

Interventions

Self-questionnaires battery OTHER

* 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)

Schizophrenia

Socio-demographic screening OTHER

age; gender; education; highest diploma; job; marital status; living place

Schizophrenia

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (2)

Grenoble University Hospital

La Tronche, 38700, France

RECRUITING

Chu St Etienne

Saint-Etienne, France

RECRUITING

Related Publications (29)

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MeSH Terms

Conditions

Schizophrenia; Hallucinations

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Clément DONDE

  CHU Grenoble Alpes

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clément DONDE

CONTACT

+33 (0)4 76 76 39 86; cdondecoquelet@chu-grenoble.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2020
• First Posted: July 22, 2020
• Study Start: September 4, 2020
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2023
• Last Updated: November 13, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)