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临床试验/NCT02397031
NCT02397031已完成不适用

Randomized, Active-controlled, Clinical Trial Comparing Effects of Mindfulness and Interpersonal Effectiveness Skills in Borderline Personality Disorder

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau0 个研究点目标入组 64 人开始时间: 2011年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
64
主要终点
change from baseline in borderline symptoms after a 10 week intervention

研究概览

简要总结

The purpose of the study was to determine whether mindfulness training could be more effective than another active intervention in reducing borderline personality disorder (BPD) symptoms. The main hypothesis was that patients allocated to the mindfulness group would show a greater improvement on global BPD symptomatology. As a second objective, we explored some of the possible underlying mechanisms of both active treatments. For that purpose, changes in decentering, mindfulness facets and cognitive processing of social interactions were also evaluated.

详细描述

The present study aimed at evaluating the efficacy of mindfulness skills (M) versus interpersonal effectiveness skills (IE) on borderline symptoms. For that purpose, a randomized, active-controlled clinical trial was designed. 64 participants with borderline personality disorder (BPD) diagnosis were allocated to mindfulness (n=32) or interpersonal effectiveness skills (n=32). Both interventions were delivered over a 10-week period. The borderline symptom list (BSL-23) was elected as the primary outcome measure. Mindfulness related capacities, decentering and cognitive processing of social interactions were also evaluated with the Five Facet Mindfulness Questionnaire (FFMQ), the Experiences Questionnaire (EQ) and the Multidimensional Scale of Social Expression (EMES-C), respectively. Assessments were conducted pre and post interventions.

研究设计

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

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Ages between 18 and 45 years
  • BPD criteria according to two diagnostic interviews (SCID-II and DIB-R)

排除标准

  • Lifetime diagnosis of schizophrenia, drug-induced psychosis, organic brain syndrome, bipolar disorder or mental retardation
  • Participating in any sort of psychotherapy during the study or having participated in dialectical behavioral therapy groups in the past

结局指标

主要结局

change from baseline in borderline symptoms after a 10 week intervention

时间窗: 10 weeks

participants were assessed pre and post interventions

次要结局

  • change from baseline in social interactions after a 10 week intervention(10 weeks)
  • change from baseline in decentering after a 10 week intervention(10 weeks)
  • change from baseline in mindfulness facets after a 10 week intervention(10 weeks)

研究者

发起方
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
申办方类型
Other
责任方
Principal Investigator
主要研究者

Juan Carlos Pascual

Psychiatrist

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

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