Short Integrative And Neurocognitive Therapy For Young Adults With Borderline Personality Disorder

Study Overview
=================
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).

Official Title
-----------------
Short Integrative And Neurocognitive Therapy For Young Adults With Borderline Personality Disorder: a Study Model of Impulsivity Management

Conditions
-----------------
Borderline Personality Disorder

Intervention / Treatment
-----------------
* Other: SINTYA


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 25 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SINTYA group<br> | Other: SINTYA<br>* 10-week psychotherapy program consisting of a weekly 1h30 hour group therapy session plus 1 hour individual therapy session<br>|
| No Intervention: Control<br> | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variation in explicit impulsivity between groups | UPPS-S (Impulsive Behavior Scale Short version score) | Baseline | 
| Variation in explicit impulsivity between groups | UPPS-S (Impulsive Behavior Scale Short version score) | Month 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variation in explicit impulsivity between groups | UPPS-S (Impulsive Behavior Scale Short version score) | Month 7 | 
| Variation in impulsiveness between groups | Barratt Impulsiveness Scale (BIS-11) (score out of 120) | Baseline | 
| Variation in impulsiveness between groups | Barratt Impulsiveness Scale (BIS-11) (score out of 120) | Month 4 | 
| Variation in impulsiveness between groups | Barratt Impulsiveness Scale (BIS-11) (score out of 120) | Month 7 | 
| BPD severity level between groups | Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) (score out of 36) | Baseline | 
| BPD severity level between groups | Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) (score out of 36) | Month 4 | 
| BPD severity level between groups | Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) (score out of 36) | Month 7 | 
| Emotional regulation capacities between groups | Difficulties in Emotion Regulation Scale (DERS-18) | Baseline | 
| Emotional regulation capacities between groups | Difficulties in Emotion Regulation Scale (DERS-18) | Month 4 | 
| Emotional regulation capacities between groups | Difficulties in Emotion Regulation Scale (DERS-18) | Month 7 | 
| Dissociative symptoms between groups | Dissociative Experiences Scale (DES): a score of 25 or higher is predictive of dissociative disorder | Baseline | 
| Dissociative symptoms between groups | Dissociative Experiences Scale (DES): a score of 25 or higher is predictive of dissociative disorder | Month 4 | 
| Dissociative symptoms between groups | Dissociative Experiences Scale (DES): a score of 25 or higher is predictive of dissociative disorder | Month 7 | 
| Aggression between groups | Aggression Questionnaire (AQ-12) | Baseline | 
| Aggression between groups | Aggression Questionnaire (AQ-12) | Month 4 | 
| Aggression between groups | Aggression Questionnaire (AQ-12) | Month 7 | 
| Ruminations between groups | Rumination Reflection Questionnaire (RRQ) | Baseline | 
| Ruminations between groups | Rumination Reflection Questionnaire (RRQ) | Month 4 | 
| Ruminations between groups | Rumination Reflection Questionnaire (RRQ) | Month 7 | 
| Number of self-destructive behaviors between groups | Number of self-destructive/self-mutilatory/parasuicidal acts reported by the patient in a clinical interview | Baseline | 
| Number of self-destructive behaviors between groups | Number of self-destructive/self-mutilatory/parasuicidal acts reported by the patient in a clinical interview | Month 4 | 
| Number of self-destructive behaviors between groups | Number of self-destructive/self-mutilatory/parasuicidal acts reported by the patient in a clinical interview | Month 7 | 
| Number of impulsive behaviors between groups | Number of impulsive behaviors (food, motor vehicles, sexual, drug-related) | Baseline | 
| Number of impulsive behaviors between groups | Number of impulsive behaviors (food, motor vehicles, sexual, drug-related) | Month 4 | 
| Number of impulsive behaviors between groups | Number of impulsive behaviors (food, motor vehicles, sexual, drug-related) | Month 7 | 
| Level of suicide risk between groups | Columbia-Suicide Severity Rating Scale (C-SSRS) | Baseline | 
| Level of suicide risk between groups | Columbia-Suicide Severity Rating Scale (C-SSRS) | Month 4 | 
| Level of suicide risk between groups | Columbia-Suicide Severity Rating Scale (C-SSRS) | Month 7 | 
| Number of psychiatric hospitalizations and emergency visits for psychiatric reasons between groups | Information taken from patient medical file | 12 Months prior to inclusion | 
| Number of psychiatric hospitalizations and emergency visits for psychiatric reasons between groups | Information taken from patient medical file | Baseline | 
| Number of psychiatric hospitalizations and emergency visits for psychiatric reasons between groups | Information taken from patient medical file | Month 4 | 
| Number of psychiatric hospitalizations and emergency visits for psychiatric reasons between groups | Information taken from patient medical file | Month 7 | 
| Psychosocial functioning between groups | Functional Assessment Staging Tool (FAST) | Baseline | 
| Psychosocial functioning between groups | Functional Assessment Staging Tool (FAST) | Month 4 | 
| Psychosocial functioning between groups | Functional Assessment Staging Tool (FAST) | Month 7 | 
| Implicit impulsivity between groups | Continuous Performance Test (CPT) | Baseline | 
| Implicit impulsivity between groups | Continuous Performance Test (CPT) | Month 4 | 
| Implicit impulsivity between groups | Continuous Performance Test (CPT) | Month 7 | 
| Neurocognitive evaluation of implicit impulsivity between groups | Emotional Stroop (SE) customized to the study | Baseline | 
| Neurocognitive evaluation of implicit impulsivity between groups | Emotional Stroop (SE) customized to the study | Month 4 | 
| Neurocognitive evaluation of implicit impulsivity between groups | Emotional Stroop (SE) customized to the study | Month 7 | 
| Risk taking between groups | Balloon Analogue Risk Task (BART) | Baseline | 
| Risk taking between groups | Balloon Analogue Risk Task (BART) | Month 4 | 
| Risk taking between groups | Balloon Analogue Risk Task (BART) | Month 7 | 
| Decision making under risk conditions between groups | Game Dice Task (GDT) | Baseline | 
| Decision making under risk conditions between groups | Game Dice Task (GDT) | Month 4 | 
| Decision making under risk conditions between groups | Game Dice Task (GDT) | Month 7 |