Effectiveness of EMDR in Borderline Personality Disorder (EMBODIER)

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.

Study Overview

Status

Recruiting

Study Type

Interventional

Enrollment (Estimated)

56

Phase

  • 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 Backup

Study Locations

    • Brescia
      • Brescia, Brescia, Italy, 25123

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

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: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EMDR intervention
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.
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.
No Intervention: Waiting List
Treatment as usual

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4 timepoints: baseline (T0), after 6 (T6), 12 (T12), 18 (T18) weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self perception of BPD symptoms
Time Frame: 4 timepoints: baseline (T0), after 6 (T6), 12 (T12), 18 (T18) weeks
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.
4 timepoints: baseline (T0), after 6 (T6), 12 (T12), 18 (T18) weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Emotion disregulation
Time Frame: 4 timepoints: baseline (T0), after 6 (T6), 12 (T12), 18 (T18) weeks
Emotion disregulation measured by the Difficulties in emotion regulation scale (DERS-36). The scale ranges from 36 to 180, with higher scores indicating greater difficulties in emotion regulation.
4 timepoints: baseline (T0), after 6 (T6), 12 (T12), 18 (T18) weeks
Ruminative thinking
Time Frame: 4 timepoints: baseline (T0), after 6 (T6), 12 (T12), 18 (T18) weeks
Ruminative thinking measured by the Rumination Response Scale (RRS). The scale ranges from 22 to 88, with higher scores indicating greater rumination.
4 timepoints: baseline (T0), after 6 (T6), 12 (T12), 18 (T18) weeks
Dissociative symptoms
Time Frame: 4 timepoints: baseline (T0), after 6 (T6), 12 (T12), 18 (T18) weeks
Dissociative symptoms measured by the Dissociative Experiences Scale (DES). The scale ranges from 0 to 100, with higher scores indicating greater dissociative experiences.
4 timepoints: baseline (T0), after 6 (T6), 12 (T12), 18 (T18) weeks

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Alessandra Minelli, Prof, Università degli Studi di Brescia

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)

October 1, 2024

Primary Completion (Estimated)

May 31, 2026

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

July 2, 2024

First Submitted That Met QC Criteria

July 2, 2024

First Posted (Actual)

July 10, 2024

Study Record Updates

Last Update Posted (Actual)

February 25, 2026

Last Update Submitted That Met QC Criteria

February 23, 2026

Last Verified

October 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • EMDR2023-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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.

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