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

NCT ID: NCT05913544

Last Updated: 2025-11-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-08
• Study Completion Date: 2026-09-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

SINTYA group

Group Type: EXPERIMENTAL

SINTYA

Intervention Type: OTHER

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

Control

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

SINTYA

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clémentine Estric

Role: PRINCIPAL_INVESTIGATOR

CHU de Nimes

Locations

CHU de Nîmes

Nîmes, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Clémentine Estric

Role: CONTACT

clementine.estric@chu-nimes.fr

04 66 68 34 26

Facility Contacts

Anissa Megzari

Role: primary

drc@chu-nimes.fr

04.66.68.42.36

Other Identifiers

NIMAO/2022-1/CE-01

Identifier Type: -

Identifier Source: org_study_id