Effectiveness of EMDR in Borderline Personality Disorder: a RCT Single-blind Study in a Real-world Care Setting
NCT Number: NCT06493708
Acronym: EMBODIER
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Borderline Personality Disorder
Interventions: OTHER: Trauma focused psychotherapy: EMDR
Sponsor: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 56
Study Design: Allocation: RANDOMIZED|Intervention Model: FACTORIAL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2026-09-01
Locations: ASST Spedali Civili Brescia, Brescia, 25123, Italy

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.

Primary Outcome Measures: 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), 4 timepoints: baseline (T0), after 6 (T6), 12 (T12), 18 (T18) weeks
Secondary Outcome Measures: Self perception of BPD symptoms, Self perception of BPD symptoms measured by the Borderline Symptom List 23 (BSL-23)., 4 timepoints: baseline (T0), after 6 (T6), 12 (T12), 18 (T18) weeks
Other Outcome Measures: Emotion disregulation, Emotion disregulation measured by the Difficulties in emotion regulation scale (DERS-36), 4 timepoints: baseline (T0), after 6 (T6), 12 (T12), 18 (T18) weeks|Ruminative thinking, Ruminative thinking measured by the Rumination Response Scale (RRS), 4 timepoints: baseline (T0), after 6 (T6), 12 (T12), 18 (T18) weeks|Dissociative symptoms, Dissociative symptoms measured by the Dissociative Experiences Scale (DES), 4 timepoints: baseline (T0), after 6 (T6), 12 (T12), 18 (T18) weeks