Clinical trial NCT06493708: Effectiveness of EMDR in Borderline Personality Disorder: a RCT Single-blind Study in a Real-world Care Setting
Official title: Effectiveness of Eye Movement Desensitization and Reprocessing (EMDR) Applied to Borderline Personality Disorder: a Randomized-controlled Single-blind Study in a Real-world Care Setting
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Borderline Personality Disorder
Lead sponsor: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Sponsor class: OTHER
First posted: 2024-07-10
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Core symptoms of BPD
timeFrame: 4 timepoints: baseline (T0), after 6 (T6), 12 (T12), 18 (T18) weeks
Secondary outcomes:
measure: Self perception of BPD symptoms
timeFrame: 4 timepoints: baseline (T0), after 6 (T6), 12 (T12), 18 (T18) weeks
Other outcomes:
measure: Emotion disregulation
timeFrame: 4 timepoints: baseline (T0), after 6 (T6), 12 (T12), 18 (T18) weeks
measure: Ruminative thinking
timeFrame: 4 timepoints: baseline (T0), after 6 (T6), 12 (T12), 18 (T18) weeks
measure: Dissociative symptoms
timeFrame: 4 timepoints: baseline (T0), after 6 (T6), 12 (T12), 18 (T18) weeks
Locations:
city: Brescia
country: Italy
facility: ASST Spedali Civili Brescia
Study officials:
affiliation: Università degli Studi di Brescia
name: Alessandra Minelli, Prof
role: PRINCIPAL_INVESTIGATOR
References: