Borderline Personality DisorderEMBODIERNCT06493708
Effectiveness of EMDR in Borderline Personality Disorder
A study testing Trauma focused psychotherapy: EMDR in people with Borderline Personality Disorder, run by Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia at 1 site in Italy.
Trial summary
Borderline personality disorder (BPD) is a severe mental disorder characterized by four major symptomatological domains: interpersonal instability, perceptive and identity disorders, emotional and behavioural dysregulation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Borderline Personality Disorder
- What is being tested?
- Trauma focused psychotherapy: EMDR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteItaly
- Study dates
- 1 Oct 2024to 1 Oct 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must be over 18 years old
- A current diagnosis of PBD according to the DSM-5 was confirmed using the SCID-5-CV and SCID-5-PD diagnostic scale
Who cannot join
- Suicidal ideation in the last 3 months (suicidal thoughts active intentionally but without specific planning or suicidal thoughts active with planning and intentionality)
- Intellectual disability
- Any active disturbance from use of substances or alcohol
- Any other diagnosis of Axis I, except for Depressive Disorders, Anxious Spectrum Disorders, Obsessive-Compulsive Disorder.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
ASST Spedali Civili Brescia
Brescia, Brescia, 25123
Stefano Barlati, Prof, stefano.barlati@unibs.it
About this study
Official title: Effectiveness of Eye Movement Desensitization and Reprocessing (EMDR) Applied to Borderline Personality Disorder: an Interventional Prospective Case Control Study in a Real-world Care Setting
Borderline personality disorder (BPD) is a severe mental disorder characterized by four major symptomatological domains: interpersonal instability, perceptive and identity disorders, emotional and behavioural dysregulation. Considering a multifactorial etiological model, it has been suggested that the interaction between behavioral, environmental and genetic factors may promote the development of BPD. Early life stress events (ELS) in childhood and adolescence are highly prevalent in this population and constitute an environmental risk factor for the development of BPD. This correlates with the fact that Post-traumatic Stress Disorder (PTSD) is frequently comorbid in BPD leading to more severe symptoms and worse psychosocial functioning. At the therapeutic level, the treatment of BPD is an open challenge as psychotherapeutic interventions are of limited effectiveness and characterized by high drop-out rates. Eye Movement Desensitization and Reprocessing (EMDR) is the gold standard for treating PTSD. However, scientific evidence on the application of EMDR in patients with BPD is limited. This study aims to assess the feasibility and effectiveness of an EMDR protocol on the nuclear symptomatology of BPD (emotional and behavioral dysregulation) in a group of DBP patients with/without PTSD comorbidity, through a systematic assessment of the peculiar dimensions of the disorder. The basic hypothesis is that EMDR, through a short-term intervention, can act both on the traumatic PTSD-like experiences reported by patients and on the clinical manifestations peculiar to DBP, in particular by improving the emotional regulation capacity of patients with BPD.
- Conditions
- Borderline Personality Disorder
- Being tested
- Trauma focused psychotherapy: EMDR
- 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.
Trauma focused psychotherapy: EMDROther
14 sessions of psychotherapy with EMDR will be carried out with patients. One session per week, lasting 90 minutes. The first two sessions will be used for the description of the EMDR method and for stabilization, then there will be treatment sessions.
| Study group | Role | What they receive |
|---|---|---|
| EMDR intervention | Experimental | 14 sessions of psychotherapy with EMDR will be carried out with patients. One session per week, lasting 90 minutes. The first two sessions will be used for the description of the EMDR method and for stabilization, then there will be treatment sessions. Receives: Other: Trauma focused psychotherapy: EMDR |
| Waiting List | No intervention | Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Core symptoms of BPD
The primary outcome is the improvement of the core symptoms of BPD, measured by the Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD). The scale ranges from 0 to 36, with higher scores indicating greater severity.
Measured: 4 timepoints: baseline (T0), after 6 (T6), 12 (T12), 18 (T18) weeks
Secondary outcomes (1)
Self perception of BPD symptoms
Self perception of BPD symptoms measured by the Borderline Symptom List 23 (BSL-23). The scale ranges from 0 to 4, with higher scores indicating greater severity.
Measured: 4 timepoints: baseline (T0), after 6 (T6), 12 (T12), 18 (T18) weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2024
- Study start1 Oct 2024
- Primary completion31 May 2026 (estimated)
- Study completion1 Oct 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
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio Vita, Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
- Investigators
- Alessandra Minelli, Prof, Principal investigator, Università degli Studi di Brescia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06493708
- Sponsor's protocol ID
- EMDR2023-02
- Acronym
- EMBODIER
- Status last verified
- Oct 2025
- First submitted
- 2 Jul 2024
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Eye Movement Desensitization and Reprocessing (EMDR) Applied to Borderline Personality Disorder: an Interventional Prospective Case Control Study in a Real-world Care Setting
- ClinicalTrials.gov ID
- NCT06493708
- Acronym / sponsor ID
- EMBODIER / EMDR2023-02
- Conditions
- Borderline Personality Disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di BresciaUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 10 Jul 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.
Borderline personality disorder (BPD) is a severe mental disorder characterized by four major symptomatological domains: interpersonal instability, perceptive and identity disorders, emotional and behavioural dysregulation. Considering a multifactorial etiological model, it has been suggested that the interaction between behavioral, environmental and genetic factors may promote the development of BPD. Early life stress events (ELS) in childhood and adolescence are highly prevalent in this population and constitute an environmental risk factor for the development of BPD. This correlates with the fact that Post-traumatic Stress Disorder (PTSD) is frequently comorbid in BPD leading to more severe symptoms and worse psychosocial functioning. At the therapeutic level, the treatment of BPD is an open challenge as psychotherapeutic interventions are of limited effectiveness and characterized by high drop-out rates. Eye Movement Desensitization and Reprocessing (EMDR) is the gold standard for treating PTSD. However, scientific evidence on the application of EMDR in patients with BPD is limited. This study aims to assess the feasibility and effectiveness of an EMDR protocol on the nuclear symptomatology of BPD (emotional and behavioral dysregulation) in a group of DBP patients with/without PTSD comorbidity, through a systematic assessment of the peculiar dimensions of the disorder. The basic hypothesis is that EMDR, through a short-term intervention, can act both on the traumatic PTSD-like experiences reported by patients and on the clinical manifestations peculiar to DBP, in particular by improving the emotional regulation capacity of patients with BPD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EMDR intervention | Experimental | Other: Trauma focused psychotherapy: EMDR14 sessions of psychotherapy with EMDR will be carried out with patients. One session per week, lasting 90 minutes. The first two sessions will be used for the description of the EMDR method and for stabilization, then there will be treatment sessions. |
| Waiting List | No intervention | –Treatment as usual |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients must be over 18 years old
- A current diagnosis of PBD according to the DSM-5 was confirmed using the SCID-5-CV and SCID-5-PD diagnostic scale
Key exclusion criteria (4 listed)
- Suicidal ideation in the last 3 months (suicidal thoughts active intentionally but without specific planning or suicidal thoughts active with planning and intentionality)
- Intellectual disability
- Any active disturbance from use of substances or alcohol
- Any other diagnosis of Axis I, except for Depressive Disorders, Anxious Spectrum Disorders, Obsessive-Compulsive Disorder.
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 |
|---|---|---|
| Trauma focused psychotherapy: EMDR14 sessions of psychotherapy with EMDR will be carried out with patients. One session per week, lasting 90 minutes. The first two sessions will be used for the description of the EMDR method and for stabilization, then there will be treatment sessions. | Other | EMDR intervention |
Primary outcome
Core symptoms of BPD
Time frame: 4 timepoints: baseline (T0), after 6 (T6), 12 (T12), 18 (T18) weeks
The primary outcome is the improvement of the core symptoms of BPD, measured by the Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD). The scale ranges from 0 to 36, with higher scores indicating greater severity.
1 secondary outcome
Self perception of BPD symptoms
Time frame: 4 timepoints: baseline (T0), after 6 (T6), 12 (T12), 18 (T18) weeks
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 25 Feb 2026.
- Individual participant dataSharing planned: Yes
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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.
Alessandra Minelli, Prof principal investigator
Università degli Studi di Brescia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trauma focused psychotherapy: EMDR in people with Borderline Personality Disorder, run by Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia at 1 site in Italy.
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 2 inclusion and 4 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 25 Feb 2026. 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 Italy. 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 Alessandra Minelli, Prof (+39 380 3503413, alessandra.minelli@unibs.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Core symptoms of BPD (time frame: 4 timepoints: baseline (T0), after 6 (T6), 12 (T12), 18 (T18) weeks). 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 25 Feb 2026.