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

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

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).

Study Overview

• Status: Recruiting
• Conditions: Borderline Personality Disorder
• Intervention / Treatment: Other: SINTYA

• Study Type: Interventional
• Enrollment (Estimated): 74
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Clémentine Estric; Phone Number: 04 66 68 34 26; Email: clementine.estric@chu-nimes.fr

Study Locations

• France
  • Nîmes, France
    • Recruiting
    • CHU de Nîmes
    • Sub-Investigator: Mocrane Abbar
    • Contact: Anissa Megzari; Phone Number: 04.66.68.42.36; Email: drc@chu-nimes.fr
    • Principal Investigator: Clémentine Estric
    • Sub-Investigator: Jorge Lopez Castroman
    • Sub-Investigator: Ismaël Conejero
    • Sub-Investigator: Aurélie Schandrin
    • Sub-Investigator: Emmanuel Diaz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Principal Investigator: Clémentine Estric, CHU de Nîmes

Study record dates

Study Major Dates

• Study Start (Actual): November 8, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: May 22, 2023
• First Submitted That Met QC Criteria: June 12, 2023
• First Posted (Actual): June 22, 2023

Study Record Updates

• Last Update Posted (Actual): November 24, 2025
• Last Update Submitted That Met QC Criteria: November 20, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Personality Disorders; Borderline Personality Disorder
• Other Study ID Numbers: NIMAO/2022-1/CE-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All IPD that underlie results in a publication
• IPD Sharing Time Frame: Upon publication
• IPD Sharing Access Criteria: The IPD will be made available to other researchers upon reasonable request to the corresponding author
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No