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

Borderline Personality Disorder Clinical Trial

— SINTYA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05913544
• Other study ID #: NIMAO/2022-1/CE-01
• Status: Recruiting
• Phase: N/A
• Start date: November 8, 2023
• Est. completion date: September 2025

Study information

• Verified date: January 2024
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: Clémentine Estric
• Phone: 04 66 68 34 26
• Email: clementine.estric[@]chu-nimes.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 68
• Est. completion date: September 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 25 Years

Eligibility

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.

Related Conditions & MeSH terms

• Borderline Personality Disorder
• Personality Disorders

Intervention

Other:
• SINTYA
10-week psychotherapy program consisting of a weekly 1h30 hour group therapy session plus 1 hour individual therapy session

Locations

Country	Name	City	State
France	CHU de Nîmes	Nîmes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

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