跳至主要内容
临床试验/NCT03717818
NCT03717818Unknown不适用

Mechanisms of Change in Brief Treatment for Borderline Personality Disorder: A Randomized Controlled Trial

University of Lausanne Hospitals2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2018年10月19日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
80
试验地点
2
主要终点
ZAN-BPD (Zanarini Borderline Personality Disorder Scale; Zanarini, 2003)

研究概览

简要总结

The present two-arm randomized controlled study aims at testing the effects (i.e., symptom reduction) and the underlying mechanisms of change associated with a brief psychiatric treatment (10 sessions over 4 months), compared with treatment as usual. Participants undergo assessments at four points (intake, 2 months, discharge and 12 month follow-up). In addition to symptom measures, all individuals undergo a two-step assessment for the potential mechanisms of change (i.e., emotion and socio-cognitive processing): a) behavioural and b) neurofunctional. We hypothesize that change in the mechanisms explains the treatment effects. The present study uses an innovative treatment of BPD and at the same time a sophisticated assessment procedure to demonstrate the critical role of psychobiological change in emotion and sociocognitive processing in brief treatments. It will help increase the effectiveness of initial treatment phase for BPD and help diminish the societal burden of disease related with BPD. This study is funded by the Swiss National Science Foundation (SNSF).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Borderline Personality Disorder
  • age between 18 and 35

排除标准

  • non-mastery in French
  • neurological disorders
  • schizophrenia (according to DSM-5)

研究组 & 干预措施

Good Psychiatric Management-Brief

Experimental

干预措施: Good Psychiatric Management - Brief (Behavioral)

Treatment as Usual-Brief

Placebo Comparator

干预措施: treatment as usual (Behavioral)

结局指标

主要结局

ZAN-BPD (Zanarini Borderline Personality Disorder Scale; Zanarini, 2003)

时间窗: 4 months

measures borderline symptomatology from an dimensional perspective, ranges between 0 and 36 (36 being the most symptomatic), global score (sum of all 9 items coded between 0 and 4) used.

次要结局

  • BSL-23 (Borderline Symptom List, Short Version; Bohus et al., 2009)(4 months)
  • OQ-45 (Outcome Questionnaire-45.2, Lambert et al., 2004)(4 months)

研究者

发起方
University of Lausanne Hospitals
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ueli Kramer

PD Dr. phil. Head of Research

University of Lausanne Hospitals

研究点 (2)

Loading locations...

相似试验