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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03519035
Other study ID # RC31/18/0035
Secondary ID 2018-A00251-54
Status Not yet recruiting
Phase
First received
Last updated
Start date July 2018
Est. completion date July 2021

Study information

Verified date July 2018
Source University Hospital, Toulouse
Contact Anjali Mathur, MD
Phone 05 61 77 22 33
Email mathur.a@chu-toulouse.fr
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Hallucinations in borderline personality disorder are a frequent an serious trouble which have an important impact in patients lives. Despite this, they are often ignored by nursing staff, and are not an important criteria in Diagnostic and Statistical Manual (DSM) 5 and Classification Internationale des maladies (CIM-10). The main objective of our study is to assess the prevalence of this trouble in borderline personality disorder (BPD) population, and to characterize the hallucinations in order to compare our results with those of international studies.


Description:

The borderline personality disorder (BPD) is a very common personality disorder which concerns about 1.35% of total population. It is characterized by an affective, emotional, social and professional instability and an important association with comorbidities like mood disorders, post-traumatic stress disorder, addictive problems and suicide mortality. Hallucinations seem to be frequent in this personality disorder, but are not often taken in consideration by nursing staff because of massive need of attention of this kind of patient. At this moment there is no study of prevalence of this trouble in France in free environment. In the same way, there is no qualitative study about hallucinations. That is why we can do a lot of progress in this part of psychiatry.

This research is an observational study of descriptive type. Patients will be recruited in the different services. In this study, patients will have to pass different questionnaires (DIB-R, DES II, THQ, PCL-S, PSAS, qualitative questionnaire) in order to compare the characteristics between BDL patients with and without hallucinations.

For that, the investigator will meet each patient twice, after information by the medical staff of the service and consent. During the first meeting, the investigator will get the socio-demographic characteristics, the verification of inclusion and non-inclusion criteria, and the DIB-R questionnaire to know if the patient has really BPD and hallucinations or not. This is the same interview for all patients. During the second meeting, we will look for dissociative symptoms with DES II questionnaire, then traumatic symptoms and post-traumatic stress disorder with THQ and PCL-S. The PSAS and qualitative questionnaire will be used for BPD patients with hallucinations.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 317
Est. completion date July 2021
Est. primary completion date July 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- Patient aged 18 and under 75

- Patient with borderline personality disorder (formerly or newly diagnosed diagnosis)

- Patient having given his opposition to his participation in research

Exclusion Criteria:

- Schizophrenia

- Major depressive episode characterized in progress

- Manic or hypomanic episode in progress

- History of head trauma

- Stroke, Parkinson's disease, dementia

- Autism

- Mental retardation

- Patient under the age of 75

- Patient who does not read or speak French

- Patient unable to give consent (includes protected persons: guardianship, trusteeship)

- Incarcerated patient

Study Design


Intervention

Other:
To pass different questionnaires
Patients will have to pass different questionnaires (DIB-R, DES II, THQ, PCL-S, PSAS, qualitative questionnaire) in order to compare the characteristics between BDL patients with and without hallucinations.

Locations

Country Name City State
France University Hospital Toulouse Toulouse

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Presence or absence of hallucination During the first interview with the passage of the DIB-R scale It consists of determining whether or not hallucinations have occurred during the patient's life. This criterion will allow the outcome of the study to estimate the prevalence (over the last two years (as specified by the DIB-R questionnaire) but also over the lifetime to obtain additional data) hallucinatory manifestations in patients with a BDL course.
All patients will have the same first interview, with questionnaires about socio-demographic characteristics, inclusion and non-inclusion criteria, consent
1 day
Secondary Description of the patient's hallucinations Qualitative study of hallucinations (for patients who said they had or had had them during the first interview).
The Scale used is PSAS : a questionnaire for the characteristics of hallucinations When establishing the protocol, the PSAS (Psycho-Sensory Hallucinations Scale) was chosen because it is one of the only scales studying the different types of hallucinations (auditory, visual, coenesthetic, olfactory and tasteful) validated in French.
1 day
Secondary Search for dissociative elements Search for dissociative elements in the patient with the scale: DES-II DES-II is a self-questionnaire to detect individuals with a dissociative disorder or disorder with a high dissociative component, as well as to quantify dissociative experiences. It consists of 28 questions on situations in which the subject indicates, in percentage, the frequency with which each situation occurs. 1 day
Secondary Investigation of traumatic elements Investigation of traumatic elements and post-traumatic stress disorder (PTSD) with the scales used: THQ THQ is a self-administered questionnaire consisting of 24 closed questions (yes / no) evaluating the presence of a number of potentially traumatic events in the life of an individual. They are divided into 3 categories (crime, natural disasters and traumas, physical and sexual experiences) 1 day
Secondary Investigation of traumatic elements Investigation of traumatic elements and post-traumatic stress disorder (PTSD) with the scales used: PCL-S PCL-S is a self-administered questionnaire that evaluates the symptoms of PTSD. It is translated into French and validated for the detection and monitoring of PTSD. It assesses the existence of PTSD symptoms related to a specific and identified traumatic event. In this study we define the specific traumatic event with the patient before the handover. The questionnaire consists of 17 questions around the main symptoms described by the DSM-IV 1 day
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