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Study of Hallucinations in Patients With Borderline Personality Disorder

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ClinicalTrials.gov Identifier: NCT03519035
Recruitment Status : Not yet recruiting
First Posted : May 8, 2018
Last Update Posted : July 20, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

Brief 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.

Condition or disease Intervention/treatment
Borderline Personality Disorder Other: To pass different questionnaires

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.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 317 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 3 Weeks
Official Title: Study of Prevalence and Characteristics of Hallucinations in Patients With Borderline Personality Disorder
Estimated Study Start Date : July 2018
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine


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.

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.




Primary Outcome Measures :
  1. 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



Secondary Outcome Measures :
  1. Description of the patient's hallucinations [ Time Frame: 1 day ]

    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.


  2. 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.

  3. Investigation of traumatic elements [ Time Frame: 1 day ]
    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)

  4. Investigation of traumatic elements [ Time Frame: 1 day ]
    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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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient with borderline personnality disorder (BPD) and they will be recruited in the different services.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03519035


Contacts
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Contact: Anjali Mathur, MD 05 61 77 22 33 ext 33 mathur.a@chu-toulouse.fr
Contact: Isabelle Olivier, PhD 05 61 77 70 51 ext 33 olivier.i@chu-toulouse.fr

Locations
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France
University Hospital Toulouse Not yet recruiting
Toulouse, France, 31059
Contact: Anjali Mathur, MD    05 61 77 22 33 ext 33    mathur.a@chu-toulouse.fr   
Contact: Isabelle Olivier, PhD    05 61 77 70 51 ext 33    olivier.i@chu-toulouse.fr   
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
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Principal Investigator: Anjali Mathur, MD University Hospital, Toulouse

Additional Information:

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Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT03519035     History of Changes
Other Study ID Numbers: RC31/18/0035
2018-A00251-54 ( Other Identifier: ID-RCB )
First Posted: May 8, 2018    Key Record Dates
Last Update Posted: July 20, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Toulouse:
borderline
hallucinations
dissociation
post-traumatic stress disorder

Additional relevant MeSH terms:
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Disease
Personality Disorders
Borderline Personality Disorder
Mental Disorders
Perceptual Disorders
Nervous System Diseases
Hallucinations
Pathologic Processes
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms