- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03519035
Study of Hallucinations in Patients With Borderline Personality Disorder
Study of Prevalence and Characteristics of Hallucinations in Patients With Borderline Personality Disorder
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Toulouse, France, 31059
- University Hospital Toulouse
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Borderline personality disorder Patient
Patients will be recruited in the different services. They have to respect inclusion criteria which are : patient with BPD (clinical diagnosis), patients 18 years of age or older, patients who can give their consent. 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. |
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Presence or absence of hallucination
Time Frame: 1 day
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Description of the patient's hallucinations
Time Frame: 1 day
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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
|
Search for dissociative elements
Time Frame: 1 day
|
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.
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1 day
|
Investigation of traumatic elements
Time Frame: 1 day
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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)
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1 day
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Investigation of traumatic elements
Time Frame: 1 day
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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
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1 day
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Anjali Mathur, MD, University Hospital, Toulouse
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RC31/18/0035
- 2018-A00251-54 (Other Identifier: ID-RCB)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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