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临床试验/NCT06493708
NCT06493708招募中不适用

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

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2024年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
56
试验地点
1
主要终点
Core symptoms of BPD

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

研究组 & 干预措施

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.

干预措施: Trauma focused psychotherapy: EMDR (Other)

Waiting List

No Intervention

Treatment as usual

结局指标

主要结局

Core symptoms of BPD

时间窗: 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.

次要结局

  • Self perception of BPD symptoms(4 timepoints: baseline (T0), after 6 (T6), 12 (T12), 18 (T18) weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Antonio Vita

Prof

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

研究点 (1)

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