Clinical trial NCT05913544: Short Integrative And Neurocognitive Therapy For Young Adults With Borderline Personality Disorder
Official title: Short Integrative And Neurocognitive Therapy For Young Adults With Borderline Personality Disorder: a Study Model of Impulsivity Management
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Borderline Personality Disorder
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2023-06-22
Enrollment: 74
Sex: ALL
Minimum age (years): 16
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Primary outcomes:
measure: Variation in explicit impulsivity between groups
timeFrame: Baseline
measure: Variation in explicit impulsivity between groups
timeFrame: Month 4
Secondary outcomes:
measure: Variation in explicit impulsivity between groups
timeFrame: Month 7
measure: Variation in impulsiveness between groups
timeFrame: Baseline
measure: Variation in impulsiveness between groups
timeFrame: Month 4
measure: Variation in impulsiveness between groups
timeFrame: Month 7
measure: BPD severity level between groups
timeFrame: Baseline
measure: BPD severity level between groups
timeFrame: Month 4
measure: BPD severity level between groups
timeFrame: Month 7
measure: Emotional regulation capacities between groups
timeFrame: Baseline
measure: Emotional regulation capacities between groups
timeFrame: Month 4
measure: Emotional regulation capacities between groups
timeFrame: Month 7
measure: Dissociative symptoms between groups
timeFrame: Baseline
measure: Dissociative symptoms between groups
timeFrame: Month 4
measure: Dissociative symptoms between groups
timeFrame: Month 7
measure: Aggression between groups
timeFrame: Baseline
measure: Aggression between groups
timeFrame: Month 4
measure: Aggression between groups
timeFrame: Month 7
measure: Ruminations between groups
timeFrame: Baseline
measure: Ruminations between groups
timeFrame: Month 4
measure: Ruminations between groups
timeFrame: Month 7
measure: Number of self-destructive behaviors between groups
timeFrame: Baseline
measure: Number of self-destructive behaviors between groups
timeFrame: Month 4
measure: Number of self-destructive behaviors between groups
timeFrame: Month 7
measure: Number of impulsive behaviors between groups
timeFrame: Baseline
measure: Number of impulsive behaviors between groups
timeFrame: Month 4
measure: Number of impulsive behaviors between groups
timeFrame: Month 7
measure: Level of suicide risk between groups
timeFrame: Baseline
measure: Level of suicide risk between groups
timeFrame: Month 4
measure: Level of suicide risk between groups
timeFrame: Month 7
measure: Number of psychiatric hospitalizations and emergency visits for psychiatric reasons between groups
timeFrame: 12 Months prior to inclusion
measure: Number of psychiatric hospitalizations and emergency visits for psychiatric reasons between groups
timeFrame: Baseline
measure: Number of psychiatric hospitalizations and emergency visits for psychiatric reasons between groups
timeFrame: Month 4
measure: Number of psychiatric hospitalizations and emergency visits for psychiatric reasons between groups
timeFrame: Month 7
measure: Psychosocial functioning between groups
timeFrame: Baseline
measure: Psychosocial functioning between groups
timeFrame: Month 4
measure: Psychosocial functioning between groups
timeFrame: Month 7
measure: Implicit impulsivity between groups
timeFrame: Baseline
measure: Implicit impulsivity between groups
timeFrame: Month 4
measure: Implicit impulsivity between groups
timeFrame: Month 7
measure: Neurocognitive evaluation of implicit impulsivity between groups
timeFrame: Baseline
measure: Neurocognitive evaluation of implicit impulsivity between groups
timeFrame: Month 4
measure: Neurocognitive evaluation of implicit impulsivity between groups
timeFrame: Month 7
measure: Risk taking between groups
timeFrame: Baseline
measure: Risk taking between groups
timeFrame: Month 4
measure: Risk taking between groups
timeFrame: Month 7
measure: Decision making under risk conditions between groups
timeFrame: Baseline
measure: Decision making under risk conditions between groups
timeFrame: Month 4
measure: Decision making under risk conditions between groups
timeFrame: Month 7
Other outcomes:
Locations:
city: Nîmes
country: France
facility: CHU de Nîmes
Study officials:
affiliation: CHU de Nimes
name: Clémentine Estric
role: PRINCIPAL_INVESTIGATOR
References: