Borderline Personality DisorderMASBNCT04948905
Assessment of Sense of Identity in Patients Diagnosed With Borderline Personality Disorder. A Pilot Study
An observational study of Borderline Personality Disorder, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Borderline Personality Disorder
- What is being tested?
- Evaluation using the Self-Defining Memory Questionnaire
- Type of treatment
- Injection or infusion
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2021to 31 Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: 30 patients diagnosed as having Bordeline Personality Disorder 30 healthy controls recruited from a poster Campaign within the various departments of Nîmes University Hospital, France.
Who may be able to join
- 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
- Subject diagnosed as having borderline personality disorder according to the DSM IV classification
Who cannot join
- 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
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Borderline Personality Disorder
- Being tested
- Evaluation using the Self-Defining Memory Questionnaire
- Keywords
- Personality Disorder,, Borderline, Psychology, Self-Identity
- Medical subject headings
- Borderline Personality Disorder, Personality Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation using the Self-Defining Memory QuestionnaireOther
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Evaluation using the Self-Defining Memory Questionnaire | |
| 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. Receives: Other: Evaluation using the Self-Defining Memory Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Day 7
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).
Measured: Day 7
Secondary outcomes (8)
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
Measured: Day 7
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
Measured: Day 7
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.
Measured: Day 7
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.
Measured: Day 7
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.
Measured: Day 7
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.
Measured: Day 7
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.
Measured: Day 7
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.
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2021
- Study start1 Mar 2021
- Primary completion31 Jul 2022
- Study completion31 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Borderline Personality DisorderStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jorge LOPEZ-CASTROMAN, Prof., Principal investigator, Psychiatric Unit, Nîmes University Hospital, FranceStéphane RAFFARD, Prof., Study director, Montpellier University III, Laboratoire Epsylon, Route de Mende, 34090 Montpellier, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04948905
- Sponsor's protocol ID
- Local/2021/AS-01
- Other IDs
- 2020-A03352-37
- Acronym
- MASB
- Status last verified
- Jan 2023
- First submitted
- 17 Jun 2021
- Last updated
- 4 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 21864212Johnson 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.
PubMed 2974863Bernstein, 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 at a glance
From the registry record, last updated by the sponsor on 4 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04948905
- Acronym / sponsor ID
- MASB / Local/2021/AS-01
- Conditions
- Borderline Personality Disorder
- Keywords
- Personality Disorder,, Borderline, Psychology, Self-Identity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 31 Jul 2022 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 2 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients diagnosed as having Borderline Personality Disorder | – | Other: Evaluation using the Self-Defining Memory QuestionnaireThese 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. |
| Healthy Controls (Patients not diagnosed as having Borderline Personality Disorder ) | – | Other: Evaluation using the Self-Defining Memory QuestionnaireThese 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 30 patients diagnosed as having Bordeline Personality Disorder 30 healthy controls recruited from a poster Campaign within the various departments of Nîmes University Hospital, France.
Key inclusion criteria (5 listed)
- 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
- Subject diagnosed as having borderline personality disorder according to the DSM IV classification
Key exclusion criteria (10 listed)
- 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
- 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.
- Subjects under court protection, guardianship or curatorship
- Subjects for whom it is impossible to give informed information
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evaluation using the Self-Defining Memory QuestionnaireThis 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). | Other | Healthy Controls (Patients not diagnosed as having Borderline Personality Disorder ), Patients diagnosed as having Borderline Personality Disorder |
Primary outcome
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).
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).
8 secondary outcomes
Self-coherence of self-defining memories in patients diagnosed with Borderline Personality Disorder
Time frame: Day 7
Self-coherence of self-defining memories in healthy controls
Time frame: Day 7
Phenomenological details of self-defining memories in patients diagnosed with Borderline Personality Disorder
Time frame: Day 7
Phenomenological details of self-defining memories in healthy controls
Time frame: Day 7
Traumas undergone in patients diagnosed with Borderline Personality Disorder: Frequency
Time frame: Day 7
Traumas undergone in healthy controls: Frequency
Time frame: Day 7
Traumas undergone in patients diagnosed with Borderline Personality Disorder: Type
Time frame: Day 7
Traumas undergone in healthy controls: Type
Time frame: Day 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2023.
- BackgroundMoffitt 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
- BackgroundSinger, 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.
- Background: PubMed 21864212Bluck 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.
- Background: PubMed 2974863Johnson 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.
- BackgroundBernstein, D. P., Fink, L., Handelsman, L., & Foote, J. Childhood Trauma Questionnaire (CTQ) [Database record].(1994) APA PsycTests. https://doi.org/10.1037/t02080-000
- BackgroundSpitzer, 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jorge LOPEZ-CASTROMAN, Prof. principal investigator
Psychiatric Unit, Nîmes University Hospital, France
Stéphane RAFFARD, Prof. study director
Montpellier University III, Laboratoire Epsylon, Route de Mende, 34090 Montpellier, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Borderline Personality Disorder, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04948905, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2023.