跳至主要内容
临床试验/DRKS00031608
DRKS00031608招募中Unknown

A mechanism-based group-psychotherapy approach to aggressive behavior (MAAP) in borderline personality disorder (BPD): a multicenter randomized controlled clinical trial - MAAP

Klinik für Allgemeine Psychiatrie0 个研究点目标入组 186 人开始时间: 2023年10月31日最近更新:
适应症

试验速览

阶段
Unknown
状态
招募中
发起方
入组人数
186

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomized controlled study
盲法
Blinded (masking used)

入排标准

年龄范围
18 Years 至 one(—)
性别
All

入选标准

  • Outpatients with at least four diagnostic criteria of BPD fulfilled according to a structured interview, the International Personality Disorder Examination (IPDE based on DSM-5)
  • Exhibit overt aggression OAS-M(1-3) = 15 and irritability OAS-M(5-6) = 6 within two weeks prior to inclusion
  • live within 70km from a study centre
  • Sufficient German language skill to participate in a group setting

排除标准

  • - Suicidality: due to the high prevalence of suicidality in patients with BPD, the possibility of initiating treatment is assessed using item 7 of the OAS-M, which captures suicidal tendencies; suicidality is assessed on an individual basis by a clinician if the score is =3
  • - Acute/previous schizophrenia
  • - Acute bipolar I disorder
  • - Acute moderate to severe substance use disorder
  • - No ability/willingness to abstain from drug/alcohol use during therapy sessions (assessed by a clinician on an individual basis)
  • - History of a serious medical condition that interferes with participation in regular sessions
  • - Severe cognitive impairment as measured by mini-q (IQ<70).
  • - Other ongoing psychotherapy
  • - Increase in current psychotropic medication or initiation of new psychotropic medication within two weeks prior to study assignment (6 weeks instead of 2 weeks for fluoxetine)
  • - Ongoing criminal investigation, placement in a forensic hospital for at least 2 years, or incarceration

研究者

发起方
Klinik für Allgemeine Psychiatrie

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