Back to resultsShort Integrative And Neurocognitive Therapy For Young Adults With Borderline Personality Disorder (SINTYA)
Primary Purpose
Borderline Personality Disorder
Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
SINTYA
Sponsored by
About this trial
This is an interventional treatment trial for Borderline Personality Disorder
Eligibility Criteria
Inclusion Criteria: Diagnosis of BPD according to DSM-5 criteria and BPQ-80 scale. High BPD severity level: ZAN-BPD (score ≥ 18/36). Understand, write and read French. Be able to understand the nature, purpose and methodology of the study and agree to cooperate during evaluations. Have signed the informed consent. For minor patients, have signed the parental consent by at least one holder of parental authority. Exclusion Criteria: Refusal to participate. Existence of a neurological pathology or cerebral sequelae of organic origin which could affect neurocognitive performance. Intelligence quotient < 70. Lifetime diagnosis of schizoaffective disorder or schizophrenia (MINI-7). Previous or current participation in specific psychotherapy for BPD. Subject deprived of liberty (by judicial or administrative decision) and/or protected by law. Inclusion in another study including psychotherapy for the duration of the study. Inclusion in a drug RIPH1 study or in a REC study (European regulation of clinical trials) for the entire duration of the study. Subject in period of exclusion from another research protocol.
Sites / Locations
- CHU de Nîmes
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
SINTYA group
Control
Arm Description
Outcomes
Primary Outcome Measures
Variation in explicit impulsivity between groups
UPPS-S (Impulsive Behavior Scale Short version score)
Variation in explicit impulsivity between groups
UPPS-S (Impulsive Behavior Scale Short version score)
Secondary Outcome Measures
Variation in explicit impulsivity between groups
UPPS-S (Impulsive Behavior Scale Short version score)
Variation in impulsiveness between groups
Barratt Impulsiveness Scale (BIS-11) (score out of 120)
Variation in impulsiveness between groups
Barratt Impulsiveness Scale (BIS-11) (score out of 120)
Variation in impulsiveness between groups
Barratt Impulsiveness Scale (BIS-11) (score out of 120)
BPD severity level between groups
Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) (score out of 36)
BPD severity level between groups
Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) (score out of 36)
BPD severity level between groups
Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) (score out of 36)
Emotional regulation capacities between groups
Difficulties in Emotion Regulation Scale (DERS-18)
Emotional regulation capacities between groups
Difficulties in Emotion Regulation Scale (DERS-18)
Emotional regulation capacities between groups
Difficulties in Emotion Regulation Scale (DERS-18)
Dissociative symptoms between groups
Dissociative Experiences Scale (DES): a score of 25 or higher is predictive of dissociative disorder
Dissociative symptoms between groups
Dissociative Experiences Scale (DES): a score of 25 or higher is predictive of dissociative disorder
Dissociative symptoms between groups
Dissociative Experiences Scale (DES): a score of 25 or higher is predictive of dissociative disorder
Aggression between groups
Aggression Questionnaire (AQ-12)
Aggression between groups
Aggression Questionnaire (AQ-12)
Aggression between groups
Aggression Questionnaire (AQ-12)
Ruminations between groups
Rumination Reflection Questionnaire (RRQ)
Ruminations between groups
Rumination Reflection Questionnaire (RRQ)
Ruminations between groups
Rumination Reflection Questionnaire (RRQ)
Number of self-destructive behaviors between groups
Number of self-destructive/self-mutilatory/parasuicidal acts reported by the patient in a clinical interview
Number of self-destructive behaviors between groups
Number of self-destructive/self-mutilatory/parasuicidal acts reported by the patient in a clinical interview
Number of self-destructive behaviors between groups
Number of self-destructive/self-mutilatory/parasuicidal acts reported by the patient in a clinical interview
Number of impulsive behaviors between groups
Number of impulsive behaviors (food, motor vehicles, sexual, drug-related)
Number of impulsive behaviors between groups
Number of impulsive behaviors (food, motor vehicles, sexual, drug-related)
Number of impulsive behaviors between groups
Number of impulsive behaviors (food, motor vehicles, sexual, drug-related)
Level of suicide risk between groups
Columbia-Suicide Severity Rating Scale (C-SSRS)
Level of suicide risk between groups
Columbia-Suicide Severity Rating Scale (C-SSRS)
Level of suicide risk between groups
Columbia-Suicide Severity Rating Scale (C-SSRS)
Number of psychiatric hospitalizations and emergency visits for psychiatric reasons between groups
Information taken from patient medical file
Number of psychiatric hospitalizations and emergency visits for psychiatric reasons between groups
Information taken from patient medical file
Number of psychiatric hospitalizations and emergency visits for psychiatric reasons between groups
Information taken from patient medical file
Number of psychiatric hospitalizations and emergency visits for psychiatric reasons between groups
Information taken from patient medical file
Psychosocial functioning between groups
Functional Assessment Staging Tool (FAST)
Psychosocial functioning between groups
Functional Assessment Staging Tool (FAST)
Psychosocial functioning between groups
Functional Assessment Staging Tool (FAST)
Implicit impulsivity between groups
Continuous Performance Test (CPT)
Implicit impulsivity between groups
Continuous Performance Test (CPT)
Implicit impulsivity between groups
Continuous Performance Test (CPT)
Neurocognitive evaluation of implicit impulsivity between groups
Emotional Stroop (SE) customized to the study
Neurocognitive evaluation of implicit impulsivity between groups
Emotional Stroop (SE) customized to the study
Neurocognitive evaluation of implicit impulsivity between groups
Emotional Stroop (SE) customized to the study
Risk taking between groups
Balloon Analogue Risk Task (BART)
Risk taking between groups
Balloon Analogue Risk Task (BART)
Risk taking between groups
Balloon Analogue Risk Task (BART)
Decision making under risk conditions between groups
Game Dice Task (GDT)
Decision making under risk conditions between groups
Game Dice Task (GDT)
Decision making under risk conditions between groups
Game Dice Task (GDT)
Full Information
NCT ID
NCT05913544
First Posted
May 22, 2023
Last Updated
June 12, 2023
Sponsor
Centre Hospitalier Universitaire de Nīmes
1. Study Identification
Unique Protocol Identification Number
NCT05913544
Brief Title
Short Integrative And Neurocognitive Therapy For Young Adults With Borderline Personality Disorder
Acronym
SINTYA
Official Title
Short Integrative And Neurocognitive Therapy For Young Adults With Borderline Personality Disorder: a Study Model of Impulsivity Management
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
September 2025 (Anticipated)
Study Completion Date
September 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nīmes
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Borderline personality disorder (BPD) is a severe, high-suicidal psychiatric disorder associated with impulsive, endangering behaviors. Young patients between 16 and 25 years old do not respond to traditional psychotherapies, which are often long and not adapted to their neurocognitive alterations linked to early trauma. The study authors hypothesize the SINTYA therapy program (one group session and one individual session weekly for 10 weeks) would reduce the level of impulsivity and clinical symptomatology (severity of the BPD; emotional regulation difficulties; dissociative symptoms; aggressiveness; ruminations; the number of self-destructive behaviors and suicidal acts; impulsive behaviors; level of suicide risk and hopelessness; the number of psychiatric hospitalizations and emergency visits for psychiatric reasons; and finally improving psychosocial functioning).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Borderline Personality Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
68 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SINTYA group
Arm Type
Experimental
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
SINTYA
Intervention Description
10-week psychotherapy program consisting of a weekly 1h30 hour group therapy session plus 1 hour individual therapy session
Primary Outcome Measure Information:
Title
Variation in explicit impulsivity between groups
Description
UPPS-S (Impulsive Behavior Scale Short version score)
Time Frame
Baseline
Title
Variation in explicit impulsivity between groups
Description
UPPS-S (Impulsive Behavior Scale Short version score)
Time Frame
Month 4
Secondary Outcome Measure Information:
Title
Variation in explicit impulsivity between groups
Description
UPPS-S (Impulsive Behavior Scale Short version score)
Time Frame
Month 7
Title
Variation in impulsiveness between groups
Description
Barratt Impulsiveness Scale (BIS-11) (score out of 120)
Time Frame
Baseline
Title
Variation in impulsiveness between groups
Description
Barratt Impulsiveness Scale (BIS-11) (score out of 120)
Time Frame
Month 4
Title
Variation in impulsiveness between groups
Description
Barratt Impulsiveness Scale (BIS-11) (score out of 120)
Time Frame
Month 7
Title
BPD severity level between groups
Description
Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) (score out of 36)
Time Frame
Baseline
Title
BPD severity level between groups
Description
Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) (score out of 36)
Time Frame
Month 4
Title
BPD severity level between groups
Description
Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) (score out of 36)
Time Frame
Month 7
Title
Emotional regulation capacities between groups
Description
Difficulties in Emotion Regulation Scale (DERS-18)
Time Frame
Baseline
Title
Emotional regulation capacities between groups
Description
Difficulties in Emotion Regulation Scale (DERS-18)
Time Frame
Month 4
Title
Emotional regulation capacities between groups
Description
Difficulties in Emotion Regulation Scale (DERS-18)
Time Frame
Month 7
Title
Dissociative symptoms between groups
Description
Dissociative Experiences Scale (DES): a score of 25 or higher is predictive of dissociative disorder
Time Frame
Baseline
Title
Dissociative symptoms between groups
Description
Dissociative Experiences Scale (DES): a score of 25 or higher is predictive of dissociative disorder
Time Frame
Month 4
Title
Dissociative symptoms between groups
Description
Dissociative Experiences Scale (DES): a score of 25 or higher is predictive of dissociative disorder
Time Frame
Month 7
Title
Aggression between groups
Description
Aggression Questionnaire (AQ-12)
Time Frame
Baseline
Title
Aggression between groups
Description
Aggression Questionnaire (AQ-12)
Time Frame
Month 4
Title
Aggression between groups
Description
Aggression Questionnaire (AQ-12)
Time Frame
Month 7
Title
Ruminations between groups
Description
Rumination Reflection Questionnaire (RRQ)
Time Frame
Baseline
Title
Ruminations between groups
Description
Rumination Reflection Questionnaire (RRQ)
Time Frame
Month 4
Title
Ruminations between groups
Description
Rumination Reflection Questionnaire (RRQ)
Time Frame
Month 7
Title
Number of self-destructive behaviors between groups
Description
Number of self-destructive/self-mutilatory/parasuicidal acts reported by the patient in a clinical interview
Time Frame
Baseline
Title
Number of self-destructive behaviors between groups
Description
Number of self-destructive/self-mutilatory/parasuicidal acts reported by the patient in a clinical interview
Time Frame
Month 4
Title
Number of self-destructive behaviors between groups
Description
Number of self-destructive/self-mutilatory/parasuicidal acts reported by the patient in a clinical interview
Time Frame
Month 7
Title
Number of impulsive behaviors between groups
Description
Number of impulsive behaviors (food, motor vehicles, sexual, drug-related)
Time Frame
Baseline
Title
Number of impulsive behaviors between groups
Description
Number of impulsive behaviors (food, motor vehicles, sexual, drug-related)
Time Frame
Month 4
Title
Number of impulsive behaviors between groups
Description
Number of impulsive behaviors (food, motor vehicles, sexual, drug-related)
Time Frame
Month 7
Title
Level of suicide risk between groups
Description
Columbia-Suicide Severity Rating Scale (C-SSRS)
Time Frame
Baseline
Title
Level of suicide risk between groups
Description
Columbia-Suicide Severity Rating Scale (C-SSRS)
Time Frame
Month 4
Title
Level of suicide risk between groups
Description
Columbia-Suicide Severity Rating Scale (C-SSRS)
Time Frame
Month 7
Title
Number of psychiatric hospitalizations and emergency visits for psychiatric reasons between groups
Description
Information taken from patient medical file
Time Frame
12 Months prior to inclusion
Title
Number of psychiatric hospitalizations and emergency visits for psychiatric reasons between groups
Description
Information taken from patient medical file
Time Frame
Baseline
Title
Number of psychiatric hospitalizations and emergency visits for psychiatric reasons between groups
Description
Information taken from patient medical file
Time Frame
Month 4
Title
Number of psychiatric hospitalizations and emergency visits for psychiatric reasons between groups
Description
Information taken from patient medical file
Time Frame
Month 7
Title
Psychosocial functioning between groups
Description
Functional Assessment Staging Tool (FAST)
Time Frame
Baseline
Title
Psychosocial functioning between groups
Description
Functional Assessment Staging Tool (FAST)
Time Frame
Month 4
Title
Psychosocial functioning between groups
Description
Functional Assessment Staging Tool (FAST)
Time Frame
Month 7
Title
Implicit impulsivity between groups
Description
Continuous Performance Test (CPT)
Time Frame
Baseline
Title
Implicit impulsivity between groups
Description
Continuous Performance Test (CPT)
Time Frame
Month 4
Title
Implicit impulsivity between groups
Description
Continuous Performance Test (CPT)
Time Frame
Month 7
Title
Neurocognitive evaluation of implicit impulsivity between groups
Description
Emotional Stroop (SE) customized to the study
Time Frame
Baseline
Title
Neurocognitive evaluation of implicit impulsivity between groups
Description
Emotional Stroop (SE) customized to the study
Time Frame
Month 4
Title
Neurocognitive evaluation of implicit impulsivity between groups
Description
Emotional Stroop (SE) customized to the study
Time Frame
Month 7
Title
Risk taking between groups
Description
Balloon Analogue Risk Task (BART)
Time Frame
Baseline
Title
Risk taking between groups
Description
Balloon Analogue Risk Task (BART)
Time Frame
Month 4
Title
Risk taking between groups
Description
Balloon Analogue Risk Task (BART)
Time Frame
Month 7
Title
Decision making under risk conditions between groups
Description
Game Dice Task (GDT)
Time Frame
Baseline
Title
Decision making under risk conditions between groups
Description
Game Dice Task (GDT)
Time Frame
Month 4
Title
Decision making under risk conditions between groups
Description
Game Dice Task (GDT)
Time Frame
Month 7
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of BPD according to DSM-5 criteria and BPQ-80 scale.
High BPD severity level: ZAN-BPD (score ≥ 18/36).
Understand, write and read French.
Be able to understand the nature, purpose and methodology of the study and agree to cooperate during evaluations.
Have signed the informed consent.
For minor patients, have signed the parental consent by at least one holder of parental authority.
Exclusion Criteria:
Refusal to participate.
Existence of a neurological pathology or cerebral sequelae of organic origin which could affect neurocognitive performance.
Intelligence quotient < 70.
Lifetime diagnosis of schizoaffective disorder or schizophrenia (MINI-7).
Previous or current participation in specific psychotherapy for BPD.
Subject deprived of liberty (by judicial or administrative decision) and/or protected by law.
Inclusion in another study including psychotherapy for the duration of the study.
Inclusion in a drug RIPH1 study or in a REC study (European regulation of clinical trials) for the entire duration of the study.
Subject in period of exclusion from another research protocol.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clémentine Estric
Phone
06.23.60.75.92
Email
clementine.estric@chu-nimes.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clémentine Estric
Organizational Affiliation
CHU de Nimes
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Nîmes
City
Nîmes
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anissa Megzari
Phone
04.66.68.42.36
Email
drc@chu-nimes.fr
First Name & Middle Initial & Last Name & Degree
Clémentine Estric
First Name & Middle Initial & Last Name & Degree
Mocrane Abbar
First Name & Middle Initial & Last Name & Degree
Jorge Lopez Castroman
First Name & Middle Initial & Last Name & Degree
Ismael Conejero
First Name & Middle Initial & Last Name & Degree
Aurélie Schandrin
First Name & Middle Initial & Last Name & Degree
Emmanuel Diaz
12. IPD Sharing Statement
Learn more about this trial
Short Integrative And Neurocognitive Therapy For Young Adults With Borderline Personality Disorder
We'll reach out to this number within 24 hrs