SchizophreniaHADITRYOSNCT04481217
Cognitive Factors Mediating the Relationship Between Childhood Trauma and Auditory Hallucinations in Schizophrenia
A study testing Self-questionnaires battery and Socio-demographic screening in people with Schizophrenia, run by University Hospital, Grenoble at 2 sites in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Self-questionnaires battery and Socio-demographic screening
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 2 sitesFrance
- Study dates
- 4 Sep 2020to Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Schizophrenia or schizo-affective disorder
- Auditory hallucinations
- Fluent in French
- Gave informed consent
Who cannot join
- Agitation or suicide risk
- Involuntary Hospitalization
- Neurologic condition
- No informed consent
Trial locations and contacts
2 sites in 1 country.
France2 sites, 2 recruiting
- Recruiting
Grenoble University Hospital
La Tronche, 38700
Clément DONDÉ, MD PhD, cdondecoquelet@chu-grenoble.fr
- Recruiting
Chu St Etienne
Saint-Etienne
Eric FAKRA, Pr, +33 (0)4 77 82 88 52, Eric.Fakra@chu-st-etienne.fr
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Schizophrenia
- Being tested
- Self-questionnaires battery, Socio-demographic screening
- Keywords
- schizophrenia, auditory verbal hallucinations, early maladaptive schemas, dissociative symptoms, childhood traumas, mediation modeling
- Medical subject headings
- Schizophrenia, Hallucinations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-questionnaires batteryOther
- 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 screeningOther
age; gender; education; highest diploma; job; marital status; living place
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Self-questionnaires battery; Other: Socio-demographic screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
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").
Measured: Baseline
Secondary outcomes (5)
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").
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2020
- Study start4 Sep 2020
- Primary completionJul 2023 (estimated)
- Study completionJul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (29)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Clément DONDE, Principal investigator, CHU Grenoble Alpes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04481217
- Sponsor's protocol ID
- 38RC20.055
- Other IDs
- 2020-A00452-37
- Acronym
- HADITRYOS
- Status last verified
- Nov 2020
- First submitted
- 22 May 2020
- Last updated
- 13 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 22716897Varese 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.
PubMed 22461484Williams 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.
PubMed 30243100Bortolon 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.
PubMed 29023198Evans 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.
PubMed 26099655Bell 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.
PubMed 24311984Bentall 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.
PubMed 4052663Laroi 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.
PubMed 14969776Cottraux 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.
PubMed 21482232Briere J, Scott C. Assessment of trauma symptoms in eating-disordered populations. Eat Disord. 2007 Jul-Sep;15(4):347-58. doi: 10.1080/10640260701454360.
PubMed 17710571Darves-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.
PubMed 10225129Garrison 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.
PubMed 27964941
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Mediating Role of Dissociative Symptoms and Early Maladaptive Schemas in the Relationship Between Childhood Trauma and Auditory Hallucinations in Schizophrenia
- ClinicalTrials.gov ID
- NCT04481217
- Acronym / sponsor ID
- HADITRYOS / 38RC20.055
- Conditions
- Schizophrenia
- Keywords
- schizophrenia, auditory verbal hallucinations, early maladaptive schemas, dissociative symptoms, childhood traumas, mediation modeling
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 4 Sep 2020 (actual)
- Primary completion
- Jul 2023 (estimated)
- Study completion
- Jul 2023 (estimated)
- First posted
- 22 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Schizophrenia | Experimental | Other: Self-questionnaires battery, Other: Socio-demographic screeningPatients included will be diagnosed with schizophrenia or schizoaffective disorder, and experience AVH at the time of the inclusion (n= 350). All will be inpatients. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Schizophrenia or schizo-affective disorder
- Auditory hallucinations
- Fluent in French
- Gave informed consent
Key exclusion criteria (4 listed)
- Agitation or suicide risk
- Involuntary Hospitalization
- Neurologic condition
- No informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Schizophrenia |
| Socio-demographic screeningage; gender; education; highest diploma; job; marital status; living place | Other | Schizophrenia |
Primary outcome
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").
5 secondary outcomes
Defensive dissociation assessed by the Dissociative experiences scale (DES)
Time frame: Baseline
Early maladaptive schema "Abandonment", 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)
Time frame: 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 "Subjugation", which is measured by the young schema questionnaire short form (SQ-SF)
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2020.
- Background: PubMed 22716897Daalman 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.
- Background: PubMed 22461484Varese 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.
- Background: PubMed 30243100Williams 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.
- Background: PubMed 29023198Bortolon 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.
- Background: PubMed 26099655Evans 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.
- Background: PubMed 24311984Bell 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.
- Background: PubMed 4052663Bentall 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.
- Background: PubMed 14969776Laroi 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.
- BackgroundCottraux J, & Blackburn IM. Psychothérapies cognitives des troubles de la personnalité. NPG Neurologie-Psychiatrie-Gériatrie. 2007; 7(37), 41.
- BackgroundLarøi 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.
- BackgroundLaunay G, Slade P. The measurement of hallucinatory predisposition in male and female prisoners. Personality and Individual Differences. 1981; 2(3): 221-234.
- Background: PubMed 21482232Mauchand 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clément DONDE principal investigator
CHU Grenoble Alpes
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-questionnaires battery and Socio-demographic screening in people with Schizophrenia, run by University Hospital, Grenoble at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Clément DONDE (+33 (0)4 76 76 39 86, cdondecoquelet@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Auditory hallucinations measured by the Launay-Slade Hallucination Scale (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04481217, which also lists 29 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2020.