Effectiveness of EMDR in Borderline Personality Disorder: a RCT Single-blind Study in a Real-world Care Setting

NCT ID: NCT06493708

Last Updated: 2024-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-01

Study Completion Date

2026-09-01

Brief Summary

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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.

Detailed Description

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Conditions

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Borderline Personality Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

Trauma focused psychotherapy: EMDR

Intervention Type OTHER

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.

Waiting List

Treatment as usual

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Trauma focused psychotherapy: EMDR

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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

OTHER

Sponsor Role lead

Responsible Party

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Antonio Vita

Prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alessandra Minelli, Prof

Role: PRINCIPAL_INVESTIGATOR

Università degli Studi di Brescia

Locations

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ASST Spedali Civili Brescia

Brescia, , Italy

Site Status

Countries

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Italy

Central Contacts

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Alessandra Minelli, Prof

Role: CONTACT

+39 380 3503413

Stefano Barlati, Prof

Role: CONTACT

+39 338 2027373l

Other Identifiers

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EMDR2023-02

Identifier Type: -

Identifier Source: org_study_id

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