Cognitive Factors Mediating the Relationship Between Childhood Trauma and Auditory Hallucinations in Schizophrenia
NCT ID: NCT04481217
Last Updated: 2020-11-13
Study Results
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Basic Information
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UNKNOWN
NA
350 participants
INTERVENTIONAL
2020-09-04
2023-07-31
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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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.
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)
Socio-demographic screening
age; gender; education; highest diploma; job; marital status; living place
Interventions
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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)
Socio-demographic screening
age; gender; education; highest diploma; job; marital status; living place
Eligibility Criteria
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Inclusion Criteria
* Auditory hallucinations
* Fluent in French
* Gave informed consent
Exclusion Criteria
* Involuntary Hospitalization
* Neurologic condition
* No informed consent
18 Years
60 Years
ALL
No
Sponsors
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University Hospital, Grenoble
OTHER
Responsible Party
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Principal Investigators
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Clément DONDE
Role: PRINCIPAL_INVESTIGATOR
CHU Grenoble Alpes
Locations
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Grenoble University Hospital
La Tronche, , France
Chu St Etienne
Saint-Etienne, , France
Countries
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Central Contacts
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Facility Contacts
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Clément DONDÉ, MD PhD
Role: primary
Eric FAKRA, Pr
Role: primary
References
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Perona-Garcelan S, Garcia-Montes JM, Cuevas-Yust C, Perez-Alvarez M, Ductor-Recuerda MJ, Salas-Azcona R, Gomez-Gomez MT. A preliminary exploration of trauma, dissociation, and positive psychotic symptoms in a Spanish sample. J Trauma Dissociation. 2010;11(3):284-92. doi: 10.1080/15299731003786462.
Pilton M, Varese F, Berry K, Bucci S. The relationship between dissociation and voices: A systematic literature review and meta-analysis. Clin Psychol Rev. 2015 Aug;40:138-55. doi: 10.1016/j.cpr.2015.06.004. Epub 2015 Jun 16.
Wright DB, Loftus EF. Measuring dissociation: comparison of alternative forms of the dissociative experiences scale. Am J Psychol. 1999 Winter;112(4):497-519.
Wright MO, Crawford E, Del Castillo D. Childhood emotional maltreatment and later psychological distress among college students: the mediating role of maladaptive schemas. Child Abuse Negl. 2009 Jan;33(1):59-68. doi: 10.1016/j.chiabu.2008.12.007. Epub 2009 Jan 23.
Young JE. Cognitive therapy for personality disorders : A schema-focused approach. Professional Resource Press/Professional Resource Exchange. 1999.
Young JE, Brown G. Young schema questionnaire short form. New York: Cognitive Therapy Centre. 1998.
Young JE, Klosko, JS, Weishaar, ME. Schema therapy : A practitioner's guide. 2005.
Hair Jr JF, Hult GTM, Ringle C, Sarstedt M. A primer on partial least squares structural equation modeling (PLS-SEM). Sage publications. 2016.
First MB, Spitzer RL, Gibbon M, Williams JB, et al. Structured clinical interview for DSM-IV axis I disorders. New York: New York State Psychiatric Institute. 1995.
Battle DE. Diagnostic and Statistical Manual of Mental Disorders (DSM). Codas. 2013;25(2):191-2. doi: 10.1590/s2317-17822013000200017. No abstract available.
Bernstein DP, Ahluvalia T, Pogge D, Handelsman L. Validity of the Childhood Trauma Questionnaire in an adolescent psychiatric population. J Am Acad Child Adolesc Psychiatry. 1997 Mar;36(3):340-8. doi: 10.1097/00004583-199703000-00012.
Bernstein DP, Stein JA, Newcomb MD, Walker E, Pogge D, Ahluvalia T, Stokes J, Handelsman L, Medrano M, Desmond D, Zule W. Development and validation of a brief screening version of the Childhood Trauma Questionnaire. Child Abuse Negl. 2003 Feb;27(2):169-90. doi: 10.1016/s0145-2134(02)00541-0.
Daalman K, Diederen KM, Derks EM, van Lutterveld R, Kahn RS, Sommer IE. Childhood trauma and auditory verbal hallucinations. Psychol Med. 2012 Dec;42(12):2475-84. doi: 10.1017/S0033291712000761. Epub 2012 Apr 16.
Varese F, Smeets F, Drukker M, Lieverse R, Lataster T, Viechtbauer W, Read J, van Os J, Bentall RP. Childhood adversities increase the risk of psychosis: a meta-analysis of patient-control, prospective- and cross-sectional cohort studies. Schizophr Bull. 2012 Jun;38(4):661-71. doi: 10.1093/schbul/sbs050. Epub 2012 Mar 29.
Williams J, Bucci S, Berry K, Varese F. Psychological mediators of the association between childhood adversities and psychosis: A systematic review. Clin Psychol Rev. 2018 Nov;65:175-196. doi: 10.1016/j.cpr.2018.05.009. Epub 2018 Jun 2.
Bortolon C, Seille J, Raffard S. Exploration of trauma, dissociation, maladaptive schemas and auditory hallucinations in a French sample. Cogn Neuropsychiatry. 2017 Nov;22(6):468-485. doi: 10.1080/13546805.2017.1387524. Epub 2017 Oct 12.
Evans GJ, Reid G, Preston P, Palmier-Claus J, Sellwood W. Trauma and psychosis: The mediating role of self-concept clarity and dissociation. Psychiatry Res. 2015 Aug 30;228(3):626-32. doi: 10.1016/j.psychres.2015.04.053. Epub 2015 Jun 11.
Bell V. A community of one: social cognition and auditory verbal hallucinations. PLoS Biol. 2013 Dec;11(12):e1001723. doi: 10.1371/journal.pbio.1001723. Epub 2013 Dec 3.
Bentall RP, Slade PD. Reality testing and auditory hallucinations: a signal detection analysis. Br J Clin Psychol. 1985 Sep;24 ( Pt 3):159-69. doi: 10.1111/j.2044-8260.1985.tb01331.x.
Laroi F, Marczewski P, Van der Linden M. Further evidence of the multi-dimensionality of hallucinatory predisposition: factor structure of a modified version of the Launay-Slade Hallucinations Scale in a normal sample. Eur Psychiatry. 2004 Feb;19(1):15-20. doi: 10.1016/S0924-9338(03)00028-2.
Cottraux J, & Blackburn IM. Psychothérapies cognitives des troubles de la personnalité. NPG Neurologie-Psychiatrie-Gériatrie. 2007; 7(37), 41.
Larøi F, Billieux J, Defeldre A-C, Ceschi, G, Van der Linden M. Factorial structure and psychometric properties of the French adaptation of the Dissociative Experiences Scale (DES) in non-clinical participants. Revue Européenne de Psychologie Appliquée/European Review of Applied Psychology. 2013; 63(4): 203-208.
Launay G, Slade P. The measurement of hallucinatory predisposition in male and female prisoners. Personality and Individual Differences. 1981; 2(3): 221-234.
Mauchand P, Lachenal-Chevallet K, Cottraux J. [Empirical validation of the Young Schema Questionnaire-Short Form (YSQ-S2) in borderline personality disorder and control subjects]. Encephale. 2011 Apr;37(2):138-43. doi: 10.1016/j.encep.2010.04.014. Epub 2010 Jul 3. French.
Briere J, Scott C. Assessment of trauma symptoms in eating-disordered populations. Eat Disord. 2007 Jul-Sep;15(4):347-58. doi: 10.1080/10640260701454360.
Darves-Bornoz JM, Degiovanni A, Gaillard P. Validation of a French version of the Dissociative Experiences Scale in a rape-victim population. Can J Psychiatry. 1999 Apr;44(3):271-5. doi: 10.1177/070674379904400308.
Garrison JR, Moseley P, Alderson-Day B, Smailes D, Fernyhough C, Simons JS. Testing continuum models of psychosis: No reduction in source monitoring ability in healthy individuals prone to auditory hallucinations. Cortex. 2017 Jun;91:197-207. doi: 10.1016/j.cortex.2016.11.011. Epub 2016 Nov 22.
Johns LC, Kompus K, Connell M, Humpston C, Lincoln TM, Longden E, Preti A, Alderson-Day B, Badcock JC, Cella M, Fernyhough C, McCarthy-Jones S, Peters E, Raballo A, Scott J, Siddi S, Sommer IE, Laroi F. Auditory verbal hallucinations in persons with and without a need for care. Schizophr Bull. 2014 Jul;40 Suppl 4(Suppl 4):S255-64. doi: 10.1093/schbul/sbu005.
Perona-Garcelan S, Carrascoso-Lopez F, Garcia-Montes JM, Ductor-Recuerda MJ, Lopez Jimenez AM, Vallina-Fernandez O, Perez-Alvarez M, Gomez-Gomez MT. Dissociative experiences as mediators between childhood trauma and auditory hallucinations. J Trauma Stress. 2012 Jun;25(3):323-9. doi: 10.1002/jts.21693. Epub 2012 May 15.
Other Identifiers
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2020-A00452-37
Identifier Type: OTHER
Identifier Source: secondary_id
38RC20.055
Identifier Type: -
Identifier Source: org_study_id