NCT05913544 Short Integrative And Neurocognitive Therapy For Young Adults With Borderline Personality Disorder
| NCT ID | NCT05913544 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier Universitaire de Nīmes |
| Condition | Borderline Personality Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 74 participants |
| Start Date | 2023-11-08 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 74 participants in total. It began in 2023-11-08 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
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.
Contact & Investigator
Clémentine Estric
PRINCIPAL INVESTIGATOR
CHU de Nimes
Frequently Asked Questions
Who can join the NCT05913544 clinical trial?
This trial is open to participants of all sexes, aged 16 Years or older, up to 25 Years, studying Borderline Personality Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05913544 currently recruiting?
Yes, NCT05913544 is actively recruiting participants. Contact the research team at clementine.estric@chu-nimes.fr for enrollment information.
Where is the NCT05913544 trial being conducted?
This trial is being conducted at Nîmes, France.
Who is sponsoring the NCT05913544 clinical trial?
NCT05913544 is sponsored by Centre Hospitalier Universitaire de Nīmes. The principal investigator is Clémentine Estric at CHU de Nimes. The trial plans to enroll 74 participants.