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

NCT05913544 | Recruiting

• 1 other identifier: NIMAO/2022-1/CE-01
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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).

Conditions

Borderline Personality Disorder

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (47)

• Variation in explicit impulsivity between groups

  Month 7

• Variation in impulsiveness between groups

  Baseline

• Variation in impulsiveness between groups

  Month 4

• Variation in impulsiveness between groups

  Month 7

• BPD severity level between groups

  Baseline

Study Arms (2)

SINTYA group

EXPERIMENTAL

Other: SINTYA

Control

NO INTERVENTION

Interventions

SINTYA OTHER

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

SINTYA group

Eligibility Criteria

• Age: 16 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

CHU de Nîmes

Nîmes, France

RECRUITING

MeSH Terms

Conditions

Borderline Personality Disorder

Condition Hierarchy (Ancestors)

Personality Disorders; Mental Disorders

Study Officials

• Clémentine Estric

  CHU de Nimes

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clémentine Estric

CONTACT

04 66 68 34 26; clementine.estric@chu-nimes.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2023
• First Posted: June 22, 2023
• Study Start: November 8, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: November 24, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Upon publication
• Access Criteria: The IPD will be made available to other researchers upon reasonable request to the corresponding author

Locations

FR (1)