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

November 12, 2020 updated by: University Hospital, Grenoble

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

350

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Schizophrenia
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
  • 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)
Other: Socio-demographic screening
age; gender; education; highest diploma; job; marital status; living place

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Auditory hallucinations measured by the Launay-Slade Hallucination Scale
Time Frame: Baseline

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)
Time Frame: Baseline
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)
Time Frame: Baseline
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)
Time Frame: Baseline
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)
Time Frame: Baseline
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)
Time Frame: Baseline
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 4, 2020

Primary Completion (Anticipated)

July 1, 2023

Study Completion (Anticipated)

July 1, 2023

Study Registration Dates

First Submitted

May 22, 2020

First Submitted That Met QC Criteria

July 21, 2020

First Posted (Actual)

July 22, 2020

Study Record Updates

Last Update Posted (Actual)

November 13, 2020

Last Update Submitted That Met QC Criteria

November 12, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 38RC20.055
  • 2020-A00452-37 (Other Identifier: ID RCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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