NCT06493708

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
4mo left

Started Oct 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress82%
Oct 2024Oct 2026

First Submitted

Initial submission to the registry

July 2, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 10, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2024

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2026

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

February 25, 2026

Status Verified

October 1, 2025

Enrollment Period

1.7 years

First QC Date

July 2, 2024

Last Update Submit

February 23, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    4 timepoints: baseline (T0), after 6 (T6), 12 (T12), 18 (T18) weeks

Secondary Outcomes (1)

  • Self perception of BPD symptoms

    4 timepoints: baseline (T0), after 6 (T6), 12 (T12), 18 (T18) weeks

Other Outcomes (3)

  • Emotion disregulation

    4 timepoints: baseline (T0), after 6 (T6), 12 (T12), 18 (T18) weeks

  • Ruminative thinking

    4 timepoints: baseline (T0), after 6 (T6), 12 (T12), 18 (T18) weeks

  • Dissociative symptoms

    4 timepoints: baseline (T0), after 6 (T6), 12 (T12), 18 (T18) weeks

Study Arms (2)

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.

Other: Trauma focused psychotherapy: EMDR

Waiting List

NO INTERVENTION

Treatment as usual

Interventions

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.

EMDR intervention

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ASST Spedali Civili Brescia

Brescia, Brescia, 25123, Italy

RECRUITING

MeSH Terms

Conditions

Borderline Personality Disorder

Condition Hierarchy (Ancestors)

Personality DisordersMental Disorders

Study Officials

  • Alessandra Minelli, Prof

    Università degli Studi di Brescia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alessandra Minelli, Prof

CONTACT

Stefano Barlati, Prof

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof

Study Record Dates

First Submitted

July 2, 2024

First Posted

July 10, 2024

Study Start

October 1, 2024

Primary Completion (Estimated)

May 31, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

February 25, 2026

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will share

Locations