NCT03519035

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
317

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 16, 2018

Completed
22 days until next milestone

First Posted

Study publicly available on registry

May 8, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2018

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

July 20, 2018

Status Verified

July 1, 2018

Enrollment Period

3 years

First QC Date

April 16, 2018

Last Update Submit

July 18, 2018

Conditions

Borderline Personality Disorder

Keywords

borderlinehallucinationsdissociationpost-traumatic stress disorder

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Description of the patient's hallucinations

    1 day

  • Search for dissociative elements

    1 day

  • Investigation of traumatic elements

    1 day

  • Investigation of traumatic elements

    1 day

Study Arms (1)

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

Interventions

To pass different questionnairesOTHER

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.

Borderline personality disorder Patient

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient with borderline personnality disorder (BPD) and they will be recruited in the different services.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Toulouse

Toulouse, 31059, France

Location

MeSH Terms

Conditions

Borderline Personality DisorderHallucinationsDissociative DisordersStress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Personality DisordersMental DisordersPerceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsStress Disorders, TraumaticTrauma and Stressor Related Disorders

Study Officials

  • Anjali Mathur, MD

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Anjali Mathur, MD

CONTACT

05 61 77 22 33mathur.a@chu-toulouse.fr

Isabelle Olivier, PhD

CONTACT

05 61 77 70 51olivier.i@chu-toulouse.fr

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
3 Weeks
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 16, 2018

First Posted

May 8, 2018

Study Start

July 1, 2018

Primary Completion

July 1, 2021

Study Completion

July 1, 2021

Last Updated

July 20, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)