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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04948905
Other study ID # Local/2021/AS-01
Secondary ID 2020-A03352-37
Status Completed
Phase
First received
Last updated
Start date March 1, 2021
Est. completion date July 31, 2022

Study information

Verified date January 2023
Source Centre Hospitalier Universitaire de Nimes
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date July 31, 2022
Est. primary completion date July 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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 Design


Intervention

Other:
Evaluation using the Self-Defining Memory Questionnaire
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).

Locations

Country Name City State
France Nîmes University Hospital Nîmes Gard

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

References & Publications (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

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. — View Citation

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. — View Citation

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.

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

Outcome

Type Measure Description Time frame Safety issue
Other Age of patients diagnosed with Borderline Personality Disorder In years Day 0
Other Age of healthy controls In years Day 0
Other Sex of patients diagnosed with Borderline Personality Disorder Male/Female Day 0
Other Sex of healthy controls Male/Female Day 0
Other Level of education of patients diagnosed with Borderline Personality Disorder The level of education (Primary, Secondary, University, Post-graduateā€¦) will be recorded. Day 0
Other Level of education of healthy controls The level of education (Primary, Secondary, University, Post-graduateā€¦) will be recorded. Day 0
Other Type of trauma undergone by patients diagnosed with Borderline Personality Disorder The type of trauma undergone (physical or emotional negligence, physical, sexual or emotional abuse) will be recorded. Day 7
Other Type of trauma undergone by healthy controls The type of trauma undergone (physical or emotional negligence, physical, sexual or emotional abuse) will be recorded. Day 7
Other Contents of the self-defining memory in patients diagnosed with Borderline Personality Disorder The contents of the self-defining memory (traumatic memory, neutral memory, pleasant memory) will be recorded. Day 7
Other Contents of the self-defining memory in healthy controls The contents of the self-defining memory (traumatic memory, neutral memory, pleasant memory) will be recorded. Day 7
Other Other observations in patients diagnosed with Borderline Personality Disorder 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 Other observations in healthy controls 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
Primary Sense of Identity in patients diagnosed with Borderline Personality Disorder according to the results of the Self-Defining Memory questionnaire. 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
Primary Sense of Identity in healthy controls according to the results of the Self-Defining Memory questionnaire. 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 Self-coherence of self-defining memories in patients diagnosed with Borderline Personality Disorder 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:
The self-continuity function
The social bonding function
The directing behavior function
Day 7
Secondary Self-coherence of self-defining memories in healthy controls 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:
The self-continuity function
The social bonding function
The directing behavior function
Day 7
Secondary Phenomenological details of self-defining memories in patients diagnosed with Borderline Personality Disorder 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
Secondary Phenomenological details of self-defining memories in healthy controls 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
Secondary Traumas undergone in patients diagnosed with Borderline Personality Disorder: Frequency 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
Secondary Traumas undergone in healthy controls: Frequency 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
Secondary Traumas undergone in patients diagnosed with Borderline Personality Disorder: Type 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
Secondary Traumas undergone in healthy controls: Type 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
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