Borderline Personality DisorderrTMS-DBTNCT06259851
rTMS-enhanced Psychotherapy for Borderline Personality Disorder
A study testing Dialectical behavioral therapy program and Prefrontal rTMS treatment in people with Borderline Personality Disorder, run by Masarykova Univerzita at 1 site in Czechia.
Trial summary
This project assesses the effectiveness and lasting impact of combining Dialectical Behavioral Therapy (DBT) with prefrontal repetitive transcranial magnetic stimulation (rTMS) in patients with borderline personality disorder. Read more about this study
- Who is it for?
- Ages 16 years and older, women only
- Conditions the study is for
- Borderline Personality Disorder
- What is being tested?
- Dialectical behavioral therapy program and Prefrontal rTMS treatment
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteCzechia
- Study dates
- 20 Aug 2023to Dec 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 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- diagnosis of borderline personality disorder according to Diagnostic and Statistical Manual 5th Edition (DSM-5) criteria (rated by Structured Clinical Interview for DSM-5 for Personality Disorders, BPD section)
- minimum age 16, informed consent of the patient
- informed consent of patient's legal representative in case of patients under age 18
Who cannot join
- neurological disorder
- comorbid affective disorder or schizophrenia-related disorder
- intelligence quotient<70
- contraindications for MRI measurement
- contraindication for rTMS treatment
- pregnancy
Trial locations and contacts
1 site in 1 country.
Czechia1 site
Department of Psychiatry, University Hospital Brno and Faculty of Medicine, Masaryk University
Brno, 62500
About this study
This project assesses the effectiveness and lasting impact of combining Dialectical Behavioral Therapy (DBT) with prefrontal repetitive transcranial magnetic stimulation (rTMS) in patients with borderline personality disorder.
Read the detailed description
The proposed project aims to evaluate the effectiveness of combining Dialectical Behavioral Therapy (DBT) with prefrontal repetitive transcranial magnetic stimulation (rTMS) in individuals with borderline personality disorder (BPD). The study includes four groups of patients: 1) DBT combined with active prefrontal rTMS treatment (rTMS-DBT group), 2) DBT combined with sham rTMS treatment (sham-DBT group), 3) active prefrontal rTMS treatment only (rTMS-only group), and 4) sham rTMS treatment only (sham-only group). The study will include assessments conducted before (T1) and after the rTMS treatment (T2) composed of self-reported questionnaires, clinical interviews assessing self-harming behavior and healthcare utilization, ecological momentary assessment of emotional variability, functional magnetic resonance imaging (fMRI) during emotional task, and control clinical EEG measurements. Follow-up measurements will be conducted at T3 (three months after rTMS), and for DBT group also at T4 (six months after rTMS), and T5 (twelve months after rTMS) for to track long-term effects.
- Conditions
- Borderline Personality Disorder
- Being tested
- Dialectical behavioral therapy program, Prefrontal rTMS treatment, Sham rTMS sessions
- Keywords
- Dialectical behavioral therapy, Repetitive transcranial magnetic stimulation, Borderline personality disorder
- 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.
Dialectical behavioral therapy programBehavioural
Dialectical behavioral therapy (DBT) program with all the standard DBT modules (individual therapy 1 hour per week, skills group 3 hours per week, phone coaching, and therapist consultation team 1,5 hour per week). The program takes 24 weeks in total comprising two 12-week runs of skills training. The program will be precluded with 4 individual sessions of pretreatment before the start of the main program part.
Prefrontal rTMS treatmentDevice
rTMS will be performed by DuoMag XT with 70BF cool coil. Patients will undergo 15 daily stimulation sessions during a period of three weeks with one session each working day. Each session consists of 20 trains with 100 pulses (10 seconds for train). Inter-train interval will be 30 seconds. Gradual titration of the individual resting motor threshold (RMT) will apply, meaning probands will undergo first session with 90% RMT intensity, second session with 100% RMT intensity, third session with 110% RMT intensity. All the following sessions will use the final 120% RMT intensity. In case a session is left out because of any reason, the total duration of treatment will be prolonged by one day, so that the total number of sessions underwent is the same in all patients. Patients will receive 2000 pulses during one session (total 30000 pulses during the whole procedure) with 10 Hz frequency.
Sham rTMS sessionsDevice
Sham TMS will be performed by sham coil that looks identical to DuoMag XT in the active group. Patients will undergo 15 daily sham stimulation sessions during a period of three weeks with one session each working day. Each session consists of 20 trains with 100 pulses (10 seconds for train). Inter-train interval will be 30 seconds.
| Study group | Role | What they receive |
|---|---|---|
| rTMS-DBT group | Experimental | Patients receiving combined DBT and active prefrontal rTMS treatment Receives: Behavioral: Dialectical behavioral therapy program; Device: Prefrontal rTMS treatment |
| Sham-DBT group | Active comparator | Patients receiving combined DBT and sham rTMS treatment Receives: Behavioral: Dialectical behavioral therapy program; Device: Sham rTMS sessions |
| rTMS-only group | Active comparator | Patients receiving only active prefrontal rTMS treatment Receives: Device: Prefrontal rTMS treatment |
| sham-only group | Sham comparator | Patients receiving only sham rTMS treatment Receives: Device: Sham rTMS sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease of borderline symptoms
significant decrease of symptoms measured by Borderline Symptoms List-23
Measured: Baseline (T1), after 3 weeks (T2), 12 weeks after baseline (T3), 24 weeks after baseline (T4) in all groups and additionally 48 weeks after baseline (T5) in DBT group
Decrease of impulsivity
significant decrease of impulsivity measured by UPPS-P questionnaire
Measured: Baseline (T1), after 3 weeks (T2), 12 weeks after baseline (T3), 24 weeks after baseline (T4) in all groups and additionally 48 weeks after baseline (T5) in DBT group
Increase of emotion regulation
significant increase of emotion regulation measured by Difficulties in emotion regulation scale (minimum: 22, maximum: 87, higher score means better outcome)
Measured: Baseline (T1), after 3 weeks (T2), 12 weeks after baseline (T3), 24 weeks after baseline (T4) in all groups and additionally 48 weeks after baseline (T5) in DBT group
Decrease of self-reported depression symptoms
significant decrease of depression symptoms measured by Beck Depression Inventory II
Measured: Baseline (T1), after 3 weeks (T2), 12 weeks after baseline (T3), 24 weeks after baseline (T4) in all groups and additionally 48 weeks after baseline (T5) in DBT group
Decrease of depression symptoms clinical ranking
significant decrease of depression symptoms measured by Montgomery-Asberg Depression Rating Scale clinical rating
Measured: Baseline (T1), after 3 weeks (T2), 12 weeks after baseline (T3), 24 weeks after baseline (T4) in all groups and additionally 48 weeks after baseline (T5) in DBT group
Decrease of anxiety
significant decrease of anxiety symptoms measured by Beck Anxiety Inventory
Measured: Baseline (T1), after 3 weeks (T2), 12 weeks after baseline (T3), 24 weeks after baseline (T4) in all groups and additionally 48 weeks after baseline (T5) in DBT group
Decrease of dissociation symptoms
significant decrease of dissociation symptoms measured by Multiscale dissociation inventory
Measured: Baseline (T1), after 3 weeks (T2), 12 weeks after baseline (T3), 24 weeks after baseline (T4) in all groups and additionally 48 weeks after baseline (T5) in DBT group
Increased regulation of amygdala during fMRI neurofeedback
fMRI neurofeedback will be used to measure the participants' ability to influence their amygdala activity. fMRI neurofeedback is a method which enables measuring, computing, and displaying the current blood oxygen level-dependent (BOLD) signal level in a selected brain area. The ability of the participants to voluntarily regulate the target area activity using the feedback presentation is measured. Specifically, pictures arousing negative emotions will be presented to participants in the MR scanner together with a scale showing the current level of their right amygdala activity and participants will be instructed to decrease the scale as much as possible by regulating down their emotion (regulation condition). As a controlled condition to regulation condition, passive viewing of the negative pictures will be included (view condition).
Measured: Baseline (T1), after 3 weeks (T2), 12 weeks after baseline (T3) in all groups and additionally 24 weeks after baseline (T4) in DBT group
Decreased brain emotional reactivity
Hariri task (fMRI emotional processing task) in fMRI will be used to measure brain correlates of emotional reactivity. The task includes 2 experimental categories: 1. emotional faces and 2. emotional social scenes which reliably evoke emotional responses, and 1 control baseline condition of geometric shapes. Further, each experimental category will include three condition: negative pictures, positive pictures, and neutral pictures. Contrast of emotional conditions against neutral conditions of the same type and against control condition will be used to track the neural correlates of emotional reactivity and processing.
Measured: Baseline (T1), after 3 weeks (T2), 12 weeks after baseline (T3) in all groups and additionally 24 weeks after baseline (T4) in DBT group
Decreased impulsivity in Go/No-Go task in fMRI
fMRI Go/No-Go task will be displaying 2 experimental conditions (presenting letter A or X), where participant is asked to react with a button only in first condition (Go condition), while remain passive during the second condition (NoGo condition). The task is designed to measure impulsivity and brain correlates during inhibition.
Measured: Baseline (T1), after 3 weeks (T2), 12 weeks after baseline (T3) in all groups and additionally 24 weeks after baseline (T4) in DBT group
Decrease of emotional variability
Measured by ecological momentary assessment (EMA) implemented as an questionnaire accessible through participant's smartphone via application ExpiWell. Participants will receive notifications reminding to fill out the questionnaire every hour (in random times during the hour) between 9 am and 9 pm for two days. Participants will be asked about their current experienced emotion and its intensity. Additional questions on self-harm and suicidal thoughts intensity during the day and whether a self-harming incident has occurred during the day will be sent at 9 pm on both days.
Measured: Baseline (T1), after 3 weeks (T2), 12 weeks after baseline (T3), 24 weeks after baseline (T4) in all groups and additionally 48 weeks after baseline (T5) in DBT group
Decrease in sef-harming behavior and medical care usage
During an interview with a clinician, participants will be asked about the number of self-harming incidents and suicidal attempts and the number of crisis medical care usage and number of days spent in psychiatric hospitalization in the past 6 months or in the past three months.
Measured: Recorded for the past 6 months (at the beginning and after 48 weeks) or in the past three months (after 12 weeks and after 24 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2024
- Study start20 Aug 2023
- Primary completionDec 2026 (estimated)
- Study completionDec 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.
- 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
- Non-randomised
- Intervention model
- Factorial
- Model description
- Allocation to the Active rTMS/Sham rTMS group is randomized.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Masarykova Univerzita
- Sponsor type
- University, hospital or other
- Collaborators
- Brno University Hospital, Masaryk University
- Responsible party
- Sponsor
- Investigators
- Libor Ustohal, prof, Ph.D., Principal investigator, Brno University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06259851
- Sponsor's protocol ID
- NU23-04-00472
- Acronym
- rTMS-DBT
- Status last verified
- Sep 2025
- First submitted
- 9 Oct 2023
- Last updated
- 29 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD in anonymized form that underlie results will be shared on request after approval of principal investigator.
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- rTMS-enhanced Psychotherapy for Borderline Personality Disorder
- ClinicalTrials.gov ID
- NCT06259851
- Acronym / sponsor ID
- rTMS-DBT / NU23-04-00472
- Conditions
- Borderline Personality Disorder
- Keywords
- Dialectical behavioral therapy, Repetitive transcranial magnetic stimulation, Borderline personality disorder
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Masarykova UniverzitaUniversity, hospital or other
- Collaborators
- Brno University Hospital, Masaryk University
- Study start
- 20 Aug 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 14 Feb 2024 (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.
This project assesses the effectiveness and lasting impact of combining Dialectical Behavioral Therapy (DBT) with prefrontal repetitive transcranial magnetic stimulation (rTMS) in patients with borderline personality disorder.
Detailed description
The proposed project aims to evaluate the effectiveness of combining Dialectical Behavioral Therapy (DBT) with prefrontal repetitive transcranial magnetic stimulation (rTMS) in individuals with borderline personality disorder (BPD). The study includes four groups of patients: 1) DBT combined with active prefrontal rTMS treatment (rTMS-DBT group), 2) DBT combined with sham rTMS treatment (sham-DBT group), 3) active prefrontal rTMS treatment only (rTMS-only group), and 4) sham rTMS treatment only (sham-only group). The study will include assessments conducted before (T1) and after the rTMS treatment (T2) composed of self-reported questionnaires, clinical interviews assessing self-harming behavior and healthcare utilization, ecological momentary assessment of emotional variability, functional magnetic resonance imaging (fMRI) during emotional task, and control clinical EEG measurements. Follow-up measurements will be conducted at T3 (three months after rTMS), and for DBT group also at T4 (six months after rTMS), and T5 (twelve months after rTMS) for to track long-term effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
- Model description
- Allocation to the Active rTMS/Sham rTMS group is randomized.
| Arm | Type | Receives |
|---|---|---|
| rTMS-DBT group | Experimental | Behavioral: Dialectical behavioral therapy program, Device: Prefrontal rTMS treatmentPatients receiving combined DBT and active prefrontal rTMS treatment |
| Sham-DBT group | Active comparator | Behavioral: Dialectical behavioral therapy program, Device: Sham rTMS sessionsPatients receiving combined DBT and sham rTMS treatment |
| rTMS-only group | Active comparator | Device: Prefrontal rTMS treatmentPatients receiving only active prefrontal rTMS treatment |
| sham-only group | Sham comparator | Device: Sham rTMS sessionsPatients receiving only sham rTMS treatment |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- diagnosis of borderline personality disorder according to Diagnostic and Statistical Manual 5th Edition (DSM-5) criteria (rated by Structured Clinical Interview for DSM-5 for Personality Disorders, BPD section)
- minimum age 16, informed consent of the patient
- informed consent of patient's legal representative in case of patients under age 18
Key exclusion criteria (6 listed)
- neurological disorder
- comorbid affective disorder or schizophrenia-related disorder
- intelligence quotient<70
- contraindications for MRI measurement
- contraindication for rTMS treatment
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 |
|---|---|---|
| Dialectical behavioral therapy programDialectical behavioral therapy (DBT) program with all the standard DBT modules (individual therapy 1 hour per week, skills group 3 hours per week, phone coaching, and therapist consultation team 1,5 hour per week). The program takes 24 weeks in total comprising two 12-week runs of skills training. The program will be precluded with 4 individual sessions of pretreatment before the start of the main program part. | Behavioural | Sham-DBT group, rTMS-DBT group |
| Prefrontal rTMS treatmentrTMS will be performed by DuoMag XT with 70BF cool coil. Patients will undergo 15 daily stimulation sessions during a period of three weeks with one session each working day. Each session consists of 20 trains with 100 pulses (10 seconds for train). Inter-train interval will be 30 seconds. Gradual titration of the individual resting motor threshold (RMT) will apply, meaning probands will undergo first session with 90% RMT intensity, second session with 100% RMT intensity, third session with 110% RMT intensity. All the following sessions will use the final 120% RMT intensity. In case a session is left out because of any reason, the total duration of treatment will be prolonged by one day, so that the total number of sessions underwent is the same in all patients. Patients will receive 2000 pulses during one session (total 30000 pulses during the whole procedure) with 10 Hz frequency. | Device | rTMS-DBT group, rTMS-only group |
| Sham rTMS sessionsSham TMS will be performed by sham coil that looks identical to DuoMag XT in the active group. Patients will undergo 15 daily sham stimulation sessions during a period of three weeks with one session each working day. Each session consists of 20 trains with 100 pulses (10 seconds for train). Inter-train interval will be 30 seconds. | Device | Sham-DBT group, sham-only group |
Primary outcome
Decrease of borderline symptoms
Time frame: Baseline (T1), after 3 weeks (T2), 12 weeks after baseline (T3), 24 weeks after baseline (T4) in all groups and additionally 48 weeks after baseline (T5) in DBT group
significant decrease of symptoms measured by Borderline Symptoms List-23
Decrease of impulsivity
Time frame: Baseline (T1), after 3 weeks (T2), 12 weeks after baseline (T3), 24 weeks after baseline (T4) in all groups and additionally 48 weeks after baseline (T5) in DBT group
significant decrease of impulsivity measured by UPPS-P questionnaire
Increase of emotion regulation
Time frame: Baseline (T1), after 3 weeks (T2), 12 weeks after baseline (T3), 24 weeks after baseline (T4) in all groups and additionally 48 weeks after baseline (T5) in DBT group
significant increase of emotion regulation measured by Difficulties in emotion regulation scale (minimum: 22, maximum: 87, higher score means better outcome)
Decrease of self-reported depression symptoms
Time frame: Baseline (T1), after 3 weeks (T2), 12 weeks after baseline (T3), 24 weeks after baseline (T4) in all groups and additionally 48 weeks after baseline (T5) in DBT group
significant decrease of depression symptoms measured by Beck Depression Inventory II
Decrease of depression symptoms clinical ranking
Time frame: Baseline (T1), after 3 weeks (T2), 12 weeks after baseline (T3), 24 weeks after baseline (T4) in all groups and additionally 48 weeks after baseline (T5) in DBT group
significant decrease of depression symptoms measured by Montgomery-Asberg Depression Rating Scale clinical rating
Decrease of anxiety
Time frame: Baseline (T1), after 3 weeks (T2), 12 weeks after baseline (T3), 24 weeks after baseline (T4) in all groups and additionally 48 weeks after baseline (T5) in DBT group
significant decrease of anxiety symptoms measured by Beck Anxiety Inventory
Decrease of dissociation symptoms
Time frame: Baseline (T1), after 3 weeks (T2), 12 weeks after baseline (T3), 24 weeks after baseline (T4) in all groups and additionally 48 weeks after baseline (T5) in DBT group
significant decrease of dissociation symptoms measured by Multiscale dissociation inventory
Increased regulation of amygdala during fMRI neurofeedback
Time frame: Baseline (T1), after 3 weeks (T2), 12 weeks after baseline (T3) in all groups and additionally 24 weeks after baseline (T4) in DBT group
fMRI neurofeedback will be used to measure the participants' ability to influence their amygdala activity. fMRI neurofeedback is a method which enables measuring, computing, and displaying the current blood oxygen level-dependent (BOLD) signal level in a selected brain area. The ability of the participants to voluntarily regulate the target area activity using the feedback presentation is measured. Specifically, pictures arousing negative emotions will be presented to participants in the MR scanner together with a scale showing the current level of their right amygdala activity and participants will be instructed to decrease the scale as much as possible by regulating down their emotion (regulation condition). As a controlled condition to regulation condition, passive viewing of the negative pictures will be included (view condition).
Decreased brain emotional reactivity
Time frame: Baseline (T1), after 3 weeks (T2), 12 weeks after baseline (T3) in all groups and additionally 24 weeks after baseline (T4) in DBT group
Hariri task (fMRI emotional processing task) in fMRI will be used to measure brain correlates of emotional reactivity. The task includes 2 experimental categories: 1. emotional faces and 2. emotional social scenes which reliably evoke emotional responses, and 1 control baseline condition of geometric shapes. Further, each experimental category will include three condition: negative pictures, positive pictures, and neutral pictures. Contrast of emotional conditions against neutral conditions of the same type and against control condition will be used to track the neural correlates of emotional reactivity and processing.
Decreased impulsivity in Go/No-Go task in fMRI
Time frame: Baseline (T1), after 3 weeks (T2), 12 weeks after baseline (T3) in all groups and additionally 24 weeks after baseline (T4) in DBT group
fMRI Go/No-Go task will be displaying 2 experimental conditions (presenting letter A or X), where participant is asked to react with a button only in first condition (Go condition), while remain passive during the second condition (NoGo condition). The task is designed to measure impulsivity and brain correlates during inhibition.
Decrease of emotional variability
Time frame: Baseline (T1), after 3 weeks (T2), 12 weeks after baseline (T3), 24 weeks after baseline (T4) in all groups and additionally 48 weeks after baseline (T5) in DBT group
Measured by ecological momentary assessment (EMA) implemented as an questionnaire accessible through participant's smartphone via application ExpiWell. Participants will receive notifications reminding to fill out the questionnaire every hour (in random times during the hour) between 9 am and 9 pm for two days. Participants will be asked about their current experienced emotion and its intensity. Additional questions on self-harm and suicidal thoughts intensity during the day and whether a self-harming incident has occurred during the day will be sent at 9 pm on both days.
Decrease in sef-harming behavior and medical care usage
Time frame: Recorded for the past 6 months (at the beginning and after 48 weeks) or in the past three months (after 12 weeks and after 24 weeks)
During an interview with a clinician, participants will be asked about the number of self-harming incidents and suicidal attempts and the number of crisis medical care usage and number of days spent in psychiatric hospitalization in the past 6 months or in the past three months.
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 29 Sep 2025.
- Individual participant dataSharing planned: Yes. All IPD in anonymized form that underlie results will be shared on request after approval of principal investigator.
Related trials for Borderline Personality Disorder
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
Recruiting
Predictors of Clinical Course and Treatment Response in DBT Programmes
Self Harm, Borderline Personality Disorder
Recruiting
Effectiveness of Enhanced Dialectical Behavior Therapy Skills Training Group for Borderline Personality Disorder
Borderline Personality Disorder (BPD), Dialectical Behavior Therapy
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. This study is not recruiting at the moment.
Libor Ustohal, prof, Ph.D. principal investigator
Brno University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dialectical behavioral therapy program and Prefrontal rTMS treatment in people with Borderline Personality Disorder, run by Masarykova Univerzita at 1 site in Czechia.
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 3 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 29 Sep 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 Czechia. 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. Some participants in this study may receive a placebo. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decrease of borderline symptoms (time frame: Baseline (T1), after 3 weeks (T2), 12 weeks after baseline (T3), 24 weeks after baseline (T4) in all groups and additionally 48 weeks after baseline (T5) in DBT group). The study lists 12 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 29 Sep 2025.