- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04948905
Assessment of Sense of Identity in Patients Diagnosed With Borderline Personality Disorder. A Pilot Study (MASB)
Assessment of Sense of Identity in Patients With a Diagnosis of Borderline Personality Disorder Through Autobiographical Memory and the Contents of Self-defining Memories, Compared to a Group of Healthy Individuals. A Pilot Study
One of the key features and long considered a fundamental element of Borderline Personality Disorder is the disruption of identity. Autobiographical memory is closely linked to the development and maintenance of a coherent, stable sense of self. It enables the individual to understand who he or she is. The investigators hypothesize that individuals diagnosed with Borderline Personality Disorder have a less coherent, stable sense of the self than healthy controls. The aim of the study is therefore to compare the sense of identity between a group of patients diagnosed with Borderline Personality Disorder and a group of healthy individuals (without Borderline Personality Disorder ).
This can be measured by evaluating the content of the self-defining memory using the Self-Defining Memory scale.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Gard
-
Nîmes, Gard, France, 30029
- Nîmes University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Subject must have given written consent
- Subject affiliated or beneficiary of a health insurance plan.
- Adult subjects between 25 and 55 years of age
- Oral and written mastery of the French language
Inclusion criteria for the borderline group:
- Subject diagnosed as having borderline personality disorder according to the DSM IV classification
Exclusion criteria for the borderline group:
- Patients without diagnosis of borderline personality disorder according to the DSM IV classification after taking the SCID II (Structured Clinical Interview for DSM-III-R Axis II Disorders) test
Exclusion criteria for the control group:
- Subjects considered Borderline after taking the SCID II (Structured Clinical Interview for DSM-III-R Axis II Disorders) test
- Subjects with a score above 8 on the HADS questionnaire corresponding to questionable symptomatology for anxiety and depressive symptoms.
General exclusion Criteria:
- Subjects under court protection, guardianship or curatorship
- Subjects for whom it is impossible to give informed information
- Subjects participating in a Category 1 or 2 RIPH in the 3 months prior to the study
- Subject refusing to give written consent
- Presence of known neurological disease
- Pregnant or breastfeeding women
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Patients diagnosed as having Borderline Personality Disorder
These patients have been diagnosed as having Borderline Personality Disorder according to the Diagnostic and Statistical Manual IV classification after taking the Structured Clinical Interview for DSM-IV Axis I Disorders test.
|
This questionnaire consists of 3 pages. Page 1 gives a clear, concise definition of a memory that defines the self. This enlightens the subject on what is expected and helps him/her consider the phenomenological characteristics of the Self-Defining Memory. Page 2 recalls the 6 essential characteristics of the Self-Defining Memory. Page 3 allows the practical application of what has been understood about the questionnaire. At least 3 memories are asked of the participants. Each memory is rated as follows : On a scale of 0 - 6 for each of the following emotions, participants note how they feel when recalling each memory. Happy, Sad, Angry, Fearful, Surprised, Ashamed,Disgusted,Guilty, Interested, Embarrassed, Contemptful, Proud. 0 = not at all, 3 = Moderately and 6 = Extremely. Participants must then use the same scale to indicate the vividness and importance of the memory. They must also note the approximate number of years ago the memory took place (to the nearest whole number). |
|
Healthy Controls (Patients not diagnosed as having Borderline Personality Disorder )
These patients have NOT been diagnosed as having Borderline Personality Disorder according to the Diagnostic and Statistical Manual IV classification after taking the Structured Clinical Interview for DSM-IV Axis I Disorders test.
|
This questionnaire consists of 3 pages. Page 1 gives a clear, concise definition of a memory that defines the self. This enlightens the subject on what is expected and helps him/her consider the phenomenological characteristics of the Self-Defining Memory. Page 2 recalls the 6 essential characteristics of the Self-Defining Memory. Page 3 allows the practical application of what has been understood about the questionnaire. At least 3 memories are asked of the participants. Each memory is rated as follows : On a scale of 0 - 6 for each of the following emotions, participants note how they feel when recalling each memory. Happy, Sad, Angry, Fearful, Surprised, Ashamed,Disgusted,Guilty, Interested, Embarrassed, Contemptful, Proud. 0 = not at all, 3 = Moderately and 6 = Extremely. Participants must then use the same scale to indicate the vividness and importance of the memory. They must also note the approximate number of years ago the memory took place (to the nearest whole number). |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sense of Identity in patients diagnosed with Borderline Personality Disorder according to the results of the Self-Defining Memory questionnaire.
Time Frame: Day 7
|
The answers to the Self-Defining Memory questionnaire will be analyzed. At least 3 memories are asked of the participants. Each memory is rated as follows : On a scale of 0 - 6 for each of the following emotions, participants note how they feel when recalling each memory. Happy, Sad, Angry, Fearful, Surprised, Ashamed,Disgusted,Guilty, Interested, Embarrassed, Contemptful, Proud. 0 = not at all, 3 = Moderately and 6 = Extremely. Participants must then use the same scale to indicate the vividness and importance of the memory. They must also note the approximate number of years ago the memory took place (to the nearest whole number). |
Day 7
|
|
Sense of Identity in healthy controls according to the results of the Self-Defining Memory questionnaire.
Time Frame: Day 7
|
The answers to the Self-Defining Memory questionnaire will be analyzed. At least 3 memories are asked of the participants. Each memory is rated as follows : On a scale of 0 - 6 for each of the following emotions, participants note how they feel when recalling each memory. Happy, Sad, Angry, Fearful, Surprised, Ashamed,Disgusted,Guilty, Interested, Embarrassed, Contemptful, Proud. 0 = not at all, 3 = Moderately and 6 = Extremely. Participants must then use the same scale to indicate the vividness and importance of the memory. They must also note the approximate number of years ago the memory took place (to the nearest whole number). |
Day 7
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Self-coherence of self-defining memories in patients diagnosed with Borderline Personality Disorder
Time Frame: Day 7
|
The TALE (Thinking About Life Experiences) self-questionnaire will be used to evaluate this point. This questionnaire contains 15 items, each to be answered with a 5-point Lickert scale (1 = almost never, 5 = very frequently) with the aim of measuring 3 theoretical functions found in the autobiographic memory:
|
Day 7
|
|
Self-coherence of self-defining memories in healthy controls
Time Frame: Day 7
|
The TALE (Thinking About Life Experiences) self-questionnaire will be used to evaluate this point. This questionnaire contains 15 items, each to be answered with a 5-point Lickert scale (1 = almost never, 5 = very frequently) with the aim of measuring 3 theoretical functions found in the autobiographic memory:
|
Day 7
|
|
Phenomenological details of self-defining memories in patients diagnosed with Borderline Personality Disorder
Time Frame: Day 7
|
The Memory Characteristics Questionnaire (MCQ) will be used to compare the self-defining memories in each group of patients, Borderline vs. Controls. The MCQ is a self-administered questionnaire for the assessment of phenomenological characteristics of autobiographical memory. This measurement tool, comprising 15 items and constructed according to a 7-point Likert scale, can distinguish between memories of events, which contain more sensory and contextual details, from memories of contextual details, from memories of imagined events, which contain more elements relating to cognitive operations. |
Day 7
|
|
Phenomenological details of self-defining memories in healthy controls
Time Frame: Day 7
|
The Memory Characteristics Questionnaire (MCQ) will be used to compare the self-defining memories in each group of patients, Borderline vs. Controls. The MCQ is a self-administered questionnaire for the assessment of phenomenological characteristics of autobiographical memory. This measurement tool, comprising 15 items and constructed according to a 7-point Likert scale, can distinguish between memories of events, which contain more sensory and contextual details, from memories of contextual details, from memories of imagined events, which contain more elements relating to cognitive operations. |
Day 7
|
|
Traumas undergone in patients diagnosed with Borderline Personality Disorder: Frequency
Time Frame: Day 7
|
The Childhood Trauma Questionnaire (CTQ) will be used to evaluate the frequency of traumas undergone by the patient. The CTQ is a self-administered questionnaire of childhood and adolescent abuse. The short version, validated in French by David P Bernstein in 2003, includes 28 items and gives a quantitative estimate of the severity of maltreatment experienced. This self-administered questionnaire is based on a 5-point Likert scale and covers five main dimensions of abuse: physical abuse, sexual abuse, emotional abuse, physical neglect and emotional neglect. |
Day 7
|
|
Traumas undergone in healthy controls: Frequency
Time Frame: Day 7
|
The Childhood Trauma Questionnaire (CTQ) will be used to evaluate the frequency of traumas undergone by healthy controls. The CTQ is a self-administered questionnaire of childhood and adolescent abuse. The short version, validated in French (David P Bernstein et al. 2003), includes 28 items and gives a quantitative estimate of the severity of maltreatment experienced. This self-administered questionnaire is based on a 5-point Likert scale and covers five main dimensions of abuse: physical abuse, sexual abuse, emotional abuse, physical neglect and emotional neglect. |
Day 7
|
|
Traumas undergone in patients diagnosed with Borderline Personality Disorder: Type
Time Frame: Day 7
|
The Childhood Trauma Questionnaire (CTQ) will be used to evaluate the type of traumas undergone by the patient. The CTQ is a self-administered questionnaire of childhood and adolescent abuse. The short version, validated in French, includes 28 items and gives a quantitative estimate of the severity of maltreatment experienced. This self-administered questionnaire is based on a 5-point Likert scale and covers five main dimensions of abuse: physical abuse, sexual abuse, emotional abuse, physical neglect and emotional neglect. |
Day 7
|
|
Traumas undergone in healthy controls: Type
Time Frame: Day 7
|
The Childhood Trauma Questionnaire (CTQ) will be used to evaluate the type of traumas undergone in healthy controls: The CTQ is a self-administered questionnaire of childhood and adolescent abuse.
The short version, validated in French by David P Bernstein in 2003, includes 28 items and gives a quantitative estimate of the severity of maltreatment experienced.
This self-administered questionnaire is based on a 5-point Likert scale and covers five main dimensions of abuse: physical abuse, sexual abuse, emotional abuse, physical neglect and emotional neglect.
|
Day 7
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Age of patients diagnosed with Borderline Personality Disorder
Time Frame: Day 0
|
In years
|
Day 0
|
|
Age of healthy controls
Time Frame: Day 0
|
In years
|
Day 0
|
|
Sex of patients diagnosed with Borderline Personality Disorder
Time Frame: Day 0
|
Male/Female
|
Day 0
|
|
Sex of healthy controls
Time Frame: Day 0
|
Male/Female
|
Day 0
|
|
Level of education of patients diagnosed with Borderline Personality Disorder
Time Frame: Day 0
|
The level of education (Primary, Secondary, University, Post-graduate…) will be recorded.
|
Day 0
|
|
Level of education of healthy controls
Time Frame: Day 0
|
The level of education (Primary, Secondary, University, Post-graduate…) will be recorded.
|
Day 0
|
|
Type of trauma undergone by patients diagnosed with Borderline Personality Disorder
Time Frame: Day 7
|
The type of trauma undergone (physical or emotional negligence, physical, sexual or emotional abuse) will be recorded.
|
Day 7
|
|
Type of trauma undergone by healthy controls
Time Frame: Day 7
|
The type of trauma undergone (physical or emotional negligence, physical, sexual or emotional abuse) will be recorded.
|
Day 7
|
|
Contents of the self-defining memory in patients diagnosed with Borderline Personality Disorder
Time Frame: Day 7
|
The contents of the self-defining memory (traumatic memory, neutral memory, pleasant memory) will be recorded.
|
Day 7
|
|
Contents of the self-defining memory in healthy controls
Time Frame: Day 7
|
The contents of the self-defining memory (traumatic memory, neutral memory, pleasant memory) will be recorded.
|
Day 7
|
|
Other observations in patients diagnosed with Borderline Personality Disorder
Time Frame: Day 7
|
Calculated criteria, such as Body Mass Index, based on clinical observations not necessarily found on the case report form may be added to the final database.
|
Day 7
|
|
Other observations in healthy controls
Time Frame: Day 7
|
Calculated criteria, such as Body Mass Index, based on clinical observations not necessarily found on the case report form may be added to the final database.
|
Day 7
|
Collaborators and Investigators
Investigators
- Principal Investigator: Jorge LOPEZ-CASTROMAN, Prof., Psychiatric Unit, Nîmes University Hospital, France
- Study Director: Stéphane RAFFARD, Prof., Montpellier University III, Laboratoire Epsylon, Route de Mende, 34090 Montpellier, France
Publications and helpful links
General Publications
- Moffitt KH, Singer JA. Continuity in the Life Story: Self-Defining Memories, Affect, and Approach/Avoidance Personal Strivings. Journal of Personality.1994; 62(1), 21-43
- Singer, J. A., & Moffitt, K. H. An experimental investigation of specificity and generality in memory narratives. Imagination, Cognition and Personality. PsycINFO Database Record (1991-1992)11(3), 233-257.
- Bluck S, Alea N. Crafting the TALE: construction of a measure to assess the functions of autobiographical remembering. Memory. 2011 Jul;19(5):470-86. doi: 10.1080/09658211.2011.590500.
- Johnson MK, Foley MA, Suengas AG, Raye CL. Phenomenal characteristics of memories for perceived and imagined autobiographical events. J Exp Psychol Gen. 1988 Dec;117(4):371-6.
- Bernstein, D. P., Fink, L., Handelsman, L., & Foote, J. Childhood Trauma Questionnaire (CTQ) [Database record].(1994) APA PsycTests. https://doi.org/10.1037/t02080-000
- Spitzer, Robert L, Williams Janet BW, Gibbon Miriam, First Michael B, Structured Clinical Interview for DSM-III-R Axis II Disorders,(SCID-II), Washington, D.C.: American Psychiatric Press, Inc., 1990
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Local/2021/AS-01
- 2020-A03352-37 (Registry Identifier: N° ID-RCB)
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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