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

November 20, 2025 updated by: Centre Hospitalier Universitaire de Nīmes

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
74

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Nîmes, France
        • Recruiting
        • CHU de Nîmes
        • Sub-Investigator:
          • Mocrane Abbar
        • Contact:
        • Principal Investigator:
          • Clémentine Estric
        • Sub-Investigator:
          • Jorge Lopez Castroman
        • Sub-Investigator:
          • Ismaël Conejero
        • Sub-Investigator:
          • Aurélie Schandrin
        • Sub-Investigator:
          • Emmanuel Diaz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Variation in explicit impulsivity between groups
Time Frame: Baseline
UPPS-S (Impulsive Behavior Scale Short version score)
Baseline
Variation in explicit impulsivity between groups
Time Frame: Month 4
UPPS-S (Impulsive Behavior Scale Short version score)
Month 4

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Variation in explicit impulsivity between groups
Time Frame: Month 7
UPPS-S (Impulsive Behavior Scale Short version score)
Month 7
Variation in impulsiveness between groups
Time Frame: Baseline
Barratt Impulsiveness Scale (BIS-11) (score out of 120)
Baseline
Variation in impulsiveness between groups
Time Frame: Month 4
Barratt Impulsiveness Scale (BIS-11) (score out of 120)
Month 4
Variation in impulsiveness between groups
Time Frame: Month 7
Barratt Impulsiveness Scale (BIS-11) (score out of 120)
Month 7
BPD severity level between groups
Time Frame: Baseline
Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) (score out of 36)
Baseline
BPD severity level between groups
Time Frame: Month 4
Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) (score out of 36)
Month 4
BPD severity level between groups
Time Frame: Month 7
Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) (score out of 36)
Month 7
Emotional regulation capacities between groups
Time Frame: Baseline
Difficulties in Emotion Regulation Scale (DERS-18)
Baseline
Emotional regulation capacities between groups
Time Frame: Month 4
Difficulties in Emotion Regulation Scale (DERS-18)
Month 4
Emotional regulation capacities between groups
Time Frame: Month 7
Difficulties in Emotion Regulation Scale (DERS-18)
Month 7
Dissociative symptoms between groups
Time Frame: Baseline
Dissociative Experiences Scale (DES): a score of 25 or higher is predictive of dissociative disorder
Baseline
Dissociative symptoms between groups
Time Frame: Month 4
Dissociative Experiences Scale (DES): a score of 25 or higher is predictive of dissociative disorder
Month 4
Dissociative symptoms between groups
Time Frame: Month 7
Dissociative Experiences Scale (DES): a score of 25 or higher is predictive of dissociative disorder
Month 7
Aggression between groups
Time Frame: Baseline
Aggression Questionnaire (AQ-12)
Baseline
Aggression between groups
Time Frame: Month 4
Aggression Questionnaire (AQ-12)
Month 4
Aggression between groups
Time Frame: Month 7
Aggression Questionnaire (AQ-12)
Month 7
Ruminations between groups
Time Frame: Baseline
Rumination Reflection Questionnaire (RRQ)
Baseline
Ruminations between groups
Time Frame: Month 4
Rumination Reflection Questionnaire (RRQ)
Month 4
Ruminations between groups
Time Frame: Month 7
Rumination Reflection Questionnaire (RRQ)
Month 7
Number of self-destructive behaviors between groups
Time Frame: Baseline
Number of self-destructive/self-mutilatory/parasuicidal acts reported by the patient in a clinical interview
Baseline
Number of self-destructive behaviors between groups
Time Frame: Month 4
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
Time Frame: Month 7
Number of self-destructive/self-mutilatory/parasuicidal acts reported by the patient in a clinical interview
Month 7
Number of impulsive behaviors between groups
Time Frame: Baseline
Number of impulsive behaviors (food, motor vehicles, sexual, drug-related)
Baseline
Number of impulsive behaviors between groups
Time Frame: Month 4
Number of impulsive behaviors (food, motor vehicles, sexual, drug-related)
Month 4
Number of impulsive behaviors between groups
Time Frame: Month 7
Number of impulsive behaviors (food, motor vehicles, sexual, drug-related)
Month 7
Level of suicide risk between groups
Time Frame: Baseline
Columbia-Suicide Severity Rating Scale (C-SSRS)
Baseline
Level of suicide risk between groups
Time Frame: Month 4
Columbia-Suicide Severity Rating Scale (C-SSRS)
Month 4
Level of suicide risk between groups
Time Frame: Month 7
Columbia-Suicide Severity Rating Scale (C-SSRS)
Month 7
Number of psychiatric hospitalizations and emergency visits for psychiatric reasons between groups
Time Frame: 12 Months prior to inclusion
Information taken from patient medical file
12 Months prior to inclusion
Number of psychiatric hospitalizations and emergency visits for psychiatric reasons between groups
Time Frame: Baseline
Information taken from patient medical file
Baseline
Number of psychiatric hospitalizations and emergency visits for psychiatric reasons between groups
Time Frame: Month 4
Information taken from patient medical file
Month 4
Number of psychiatric hospitalizations and emergency visits for psychiatric reasons between groups
Time Frame: Month 7
Information taken from patient medical file
Month 7
Psychosocial functioning between groups
Time Frame: Baseline
Functional Assessment Staging Tool (FAST)
Baseline
Psychosocial functioning between groups
Time Frame: Month 4
Functional Assessment Staging Tool (FAST)
Month 4
Psychosocial functioning between groups
Time Frame: Month 7
Functional Assessment Staging Tool (FAST)
Month 7
Implicit impulsivity between groups
Time Frame: Baseline
Continuous Performance Test (CPT)
Baseline
Implicit impulsivity between groups
Time Frame: Month 4
Continuous Performance Test (CPT)
Month 4
Implicit impulsivity between groups
Time Frame: Month 7
Continuous Performance Test (CPT)
Month 7
Neurocognitive evaluation of implicit impulsivity between groups
Time Frame: Baseline
Emotional Stroop (SE) customized to the study
Baseline
Neurocognitive evaluation of implicit impulsivity between groups
Time Frame: Month 4
Emotional Stroop (SE) customized to the study
Month 4
Neurocognitive evaluation of implicit impulsivity between groups
Time Frame: Month 7
Emotional Stroop (SE) customized to the study
Month 7
Risk taking between groups
Time Frame: Baseline
Balloon Analogue Risk Task (BART)
Baseline
Risk taking between groups
Time Frame: Month 4
Balloon Analogue Risk Task (BART)
Month 4
Risk taking between groups
Time Frame: Month 7
Balloon Analogue Risk Task (BART)
Month 7
Decision making under risk conditions between groups
Time Frame: Baseline
Game Dice Task (GDT)
Baseline
Decision making under risk conditions between groups
Time Frame: Month 4
Game Dice Task (GDT)
Month 4
Decision making under risk conditions between groups
Time Frame: Month 7
Game Dice Task (GDT)
Month 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier Universitaire de Nīmes

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Clémentine Estric, CHU de Nîmes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 8, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 22, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 12, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 22, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 24, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 20, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings