Borderline Personality DisorderSINTYANCT05913544
Short Integrative And Neurocognitive Therapy For Young Adults With Borderline Personality Disorder
A study testing SINTYA in people with Borderline Personality Disorder, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 to 25 years
- Conditions the study is for
- Borderline Personality Disorder
- What is being tested?
- SINTYA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteFrance
- Study dates
- 8 Nov 2023to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU de Nîmes
Nîmes
Anissa Megzari, 04.66.68.42.36, drc@chu-nimes.fr
Clémentine Estric
About this study
Official title: 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).
- Conditions
- Borderline Personality Disorder
- Being tested
- SINTYA
- Medical subject headings
- Borderline Personality Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SINTYAOther
10-week psychotherapy program consisting of a weekly 1h30 hour group therapy session plus 1 hour individual therapy session
| Study group | Role | What they receive |
|---|---|---|
| SINTYA group | Experimental | Not described Receives: Other: SINTYA |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation in explicit impulsivity between groups
UPPS-S (Impulsive Behavior Scale Short version score)
Measured: Baseline
Variation in explicit impulsivity between groups
UPPS-S (Impulsive Behavior Scale Short version score)
Measured: Month 4
Secondary outcomes (47)
Variation in explicit impulsivity between groups
UPPS-S (Impulsive Behavior Scale Short version score)
Measured: Month 7
Variation in impulsiveness between groups
Barratt Impulsiveness Scale (BIS-11) (score out of 120)
Measured: Baseline
Variation in impulsiveness between groups
Barratt Impulsiveness Scale (BIS-11) (score out of 120)
Measured: Month 4
Variation in impulsiveness between groups
Barratt Impulsiveness Scale (BIS-11) (score out of 120)
Measured: Month 7
BPD severity level between groups
Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) (score out of 36)
Measured: Baseline
BPD severity level between groups
Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) (score out of 36)
Measured: Month 4
BPD severity level between groups
Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) (score out of 36)
Measured: Month 7
Emotional regulation capacities between groups
Difficulties in Emotion Regulation Scale (DERS-18)
Measured: Baseline
Emotional regulation capacities between groups
Difficulties in Emotion Regulation Scale (DERS-18)
Measured: Month 4
Emotional regulation capacities between groups
Difficulties in Emotion Regulation Scale (DERS-18)
Measured: Month 7
Dissociative symptoms between groups
Dissociative Experiences Scale (DES): a score of 25 or higher is predictive of dissociative disorder
Measured: Baseline
Dissociative symptoms between groups
Dissociative Experiences Scale (DES): a score of 25 or higher is predictive of dissociative disorder
Measured: Month 4
Dissociative symptoms between groups
Dissociative Experiences Scale (DES): a score of 25 or higher is predictive of dissociative disorder
Measured: Month 7
Aggression between groups
Aggression Questionnaire (AQ-12)
Measured: Baseline
Aggression between groups
Aggression Questionnaire (AQ-12)
Measured: Month 4
Aggression between groups
Aggression Questionnaire (AQ-12)
Measured: Month 7
Ruminations between groups
Rumination Reflection Questionnaire (RRQ)
Measured: Baseline
Ruminations between groups
Rumination Reflection Questionnaire (RRQ)
Measured: Month 4
Ruminations between groups
Rumination Reflection Questionnaire (RRQ)
Measured: Month 7
Number of self-destructive behaviors between groups
Number of self-destructive/self-mutilatory/parasuicidal acts reported by the patient in a clinical interview
Measured: Baseline
Number of self-destructive behaviors between groups
Number of self-destructive/self-mutilatory/parasuicidal acts reported by the patient in a clinical interview
Measured: Month 4
Number of self-destructive behaviors between groups
Number of self-destructive/self-mutilatory/parasuicidal acts reported by the patient in a clinical interview
Measured: Month 7
Number of impulsive behaviors between groups
Number of impulsive behaviors (food, motor vehicles, sexual, drug-related)
Measured: Baseline
Number of impulsive behaviors between groups
Number of impulsive behaviors (food, motor vehicles, sexual, drug-related)
Measured: Month 4
Number of impulsive behaviors between groups
Number of impulsive behaviors (food, motor vehicles, sexual, drug-related)
Measured: Month 7
Level of suicide risk between groups
Columbia-Suicide Severity Rating Scale (C-SSRS)
Measured: Baseline
Level of suicide risk between groups
Columbia-Suicide Severity Rating Scale (C-SSRS)
Measured: Month 4
Level of suicide risk between groups
Columbia-Suicide Severity Rating Scale (C-SSRS)
Measured: Month 7
Number of psychiatric hospitalizations and emergency visits for psychiatric reasons between groups
Information taken from patient medical file
Measured: 12 Months prior to inclusion
Number of psychiatric hospitalizations and emergency visits for psychiatric reasons between groups
Information taken from patient medical file
Measured: Baseline
Number of psychiatric hospitalizations and emergency visits for psychiatric reasons between groups
Information taken from patient medical file
Measured: Month 4
Number of psychiatric hospitalizations and emergency visits for psychiatric reasons between groups
Information taken from patient medical file
Measured: Month 7
Psychosocial functioning between groups
Functional Assessment Staging Tool (FAST)
Measured: Baseline
Psychosocial functioning between groups
Functional Assessment Staging Tool (FAST)
Measured: Month 4
Psychosocial functioning between groups
Functional Assessment Staging Tool (FAST)
Measured: Month 7
Implicit impulsivity between groups
Continuous Performance Test (CPT)
Measured: Baseline
Implicit impulsivity between groups
Continuous Performance Test (CPT)
Measured: Month 4
Implicit impulsivity between groups
Continuous Performance Test (CPT)
Measured: Month 7
Neurocognitive evaluation of implicit impulsivity between groups
Emotional Stroop (SE) customized to the study
Measured: Baseline
Neurocognitive evaluation of implicit impulsivity between groups
Emotional Stroop (SE) customized to the study
Measured: Month 4
Neurocognitive evaluation of implicit impulsivity between groups
Emotional Stroop (SE) customized to the study
Measured: Month 7
Risk taking between groups
Balloon Analogue Risk Task (BART)
Measured: Baseline
Risk taking between groups
Balloon Analogue Risk Task (BART)
Measured: Month 4
Risk taking between groups
Balloon Analogue Risk Task (BART)
Measured: Month 7
Decision making under risk conditions between groups
Game Dice Task (GDT)
Measured: Baseline
Decision making under risk conditions between groups
Game Dice Task (GDT)
Measured: Month 4
Decision making under risk conditions between groups
Game Dice Task (GDT)
Measured: Month 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start8 Nov 2023
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Borderline Personality DisorderStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Clémentine Estric, Principal investigator, CHU de Nimes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05913544
- Sponsor's protocol ID
- NIMAO/2022-1/CE-01
- Acronym
- SINTYA
- Status last verified
- Apr 2025
- First submitted
- 22 May 2023
- Last updated
- 24 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short Integrative And Neurocognitive Therapy For Young Adults With Borderline Personality Disorder: a Study Model of Impulsivity Management
- ClinicalTrials.gov ID
- NCT05913544
- Acronym / sponsor ID
- SINTYA / NIMAO/2022-1/CE-01
- Conditions
- Borderline Personality Disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 8 Nov 2023 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 22 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SINTYA group | Experimental | Other: SINTYA |
| Control | No intervention | – |
Who may qualify
- Ages
- 16 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SINTYA10-week psychotherapy program consisting of a weekly 1h30 hour group therapy session plus 1 hour individual therapy session | Other | SINTYA group |
Primary outcome
Variation in explicit impulsivity between groups
Time frame: Baseline
UPPS-S (Impulsive Behavior Scale Short version score)
Variation in explicit impulsivity between groups
Time frame: Month 4
UPPS-S (Impulsive Behavior Scale Short version score)
47 secondary outcomes
Variation in explicit impulsivity between groups
Time frame: Month 7
Variation in impulsiveness between groups
Time frame: Baseline
Variation in impulsiveness between groups
Time frame: Month 4
Variation in impulsiveness between groups
Time frame: Month 7
BPD severity level between groups
Time frame: Baseline
BPD severity level between groups
Time frame: Month 4
BPD severity level between groups
Time frame: Month 7
Emotional regulation capacities between groups
Time frame: Baseline
Emotional regulation capacities between groups
Time frame: Month 4
Emotional regulation capacities between groups
Time frame: Month 7
Dissociative symptoms between groups
Time frame: Baseline
Dissociative symptoms between groups
Time frame: Month 4
Dissociative symptoms between groups
Time frame: Month 7
Aggression between groups
Time frame: Baseline
Aggression between groups
Time frame: Month 4
Aggression between groups
Time frame: Month 7
Ruminations between groups
Time frame: Baseline
Ruminations between groups
Time frame: Month 4
Ruminations between groups
Time frame: Month 7
Number of self-destructive behaviors between groups
Time frame: Baseline
Number of self-destructive behaviors between groups
Time frame: Month 4
Number of self-destructive behaviors between groups
Time frame: Month 7
Number of impulsive behaviors between groups
Time frame: Baseline
Number of impulsive behaviors between groups
Time frame: Month 4
Number of impulsive behaviors between groups
Time frame: Month 7
Level of suicide risk between groups
Time frame: Baseline
Level of suicide risk between groups
Time frame: Month 4
Level of suicide risk between groups
Time frame: Month 7
Number of psychiatric hospitalizations and emergency visits for psychiatric reasons between groups
Time frame: 12 Months prior to inclusion
Number of psychiatric hospitalizations and emergency visits for psychiatric reasons between groups
Time frame: Baseline
Number of psychiatric hospitalizations and emergency visits for psychiatric reasons between groups
Time frame: Month 4
Number of psychiatric hospitalizations and emergency visits for psychiatric reasons between groups
Time frame: Month 7
Psychosocial functioning between groups
Time frame: Baseline
Psychosocial functioning between groups
Time frame: Month 4
Psychosocial functioning between groups
Time frame: Month 7
Implicit impulsivity between groups
Time frame: Baseline
Implicit impulsivity between groups
Time frame: Month 4
Implicit impulsivity between groups
Time frame: Month 7
Neurocognitive evaluation of implicit impulsivity between groups
Time frame: Baseline
Neurocognitive evaluation of implicit impulsivity between groups
Time frame: Month 4
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication
Related trials for Borderline Personality Disorder
Recruiting
Repetitive Transcranial Magnetic Stimulation Versus Theta Burst Stimulation on Impulsivity, Emotional Dysregulation, and Non-Suicidal Self-Injury in Borderline Personality Disorder Patients
Borderline Personality Disorder (BPD)
Not yet recruitingPhase 2
Ketamine Infusion for Symptomatic Improvement in Severe Borderline Personality Disorder
Infusion of Ketamine in Severe Borderline Personality Disorder, Borderline Personality Disorder (BPD)
Recruiting
Combining Transcranial Magnetic Stimulation With Emotion Regulation Skills Training in Borderline Personality Disorder
Borderline Personality Disorder (BPD)
RecruitingPhase 2
MDMA in Borderline Personality Disorder
Borderline Personality Disorder
Active, not recruitingPhase 2
Mindfulness-based Neurofeedback to Augment Psychotherapy for Adults With Borderline Personality Disorder
Borderline Personality Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Clémentine Estric principal investigator
CHU de Nimes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SINTYA in people with Borderline Personality Disorder, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clémentine Estric (04 66 68 34 26, clementine.estric@chu-nimes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variation in explicit impulsivity between groups (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2025.