跳至主要内容
临床试验/NCT00269139
NCT00269139Unknown1 期

Study of Outcome With an Intervention From the Cape Cod Model of Psychotherapy for Subjects in a Behavioral Crisis and With the Diagnosis of Borderline Personality Disorder (BPD) or Post-Traumatic Stress Disorder (PTSD)

Laddis, Andreas, M.D.1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2005年12月23日最近更新:
适应症

试验速览

阶段
1 期
发起方
入组人数
40
试验地点
1
主要终点
Brief Psychiatric Rating Scale (BPRS) scores

研究概览

简要总结

Dr. Laddis will test a hypothesis about the nature and the management of behavioral crises in patients with borderline personality disorder (BPD) or post-traumatic stress disorder (PTSD). The term "behavioral crisis" is used strictly for periods of uncontrollable urges to repeat mental or outward activity, e.g., flashbacks, cutting, binging on food, drugs or sex, with no intervals to rethink one's priorities or to consider others' direction.

The clinical hypothesis states, in two steps, that:

  1. the perception of a life crisis precedes and then underlies every behavioral crisis;
  2. the behavioral crisis resolves promptly and all symptoms end if the clinicians engage the patient about his management of the life crisis that underlies the symptoms.

详细描述

Subjects in the experimental group will be treated by Dr. Laddis after their admission to a crisis stabilization unit (CSU) or to an inpatient unit (IPU) for a behavioral crisis. Subjects will be included at random, as assigned to Dr. Laddis according to his routine duties at those units.

Subjects in the control group will receive treatment for behavioral crisis according to the preference of the clinical staff at other comparable units. That treatment will constitute "treatment as usual". Clinicians in the control settings will not be informed about the experimental hypothesis, the clinical intervention and the contingent outcomes.

The subjects will be tested for the results of treatment 12-24 hours after composition of a treatment plan. The testing will be done with the Brief Psychiatric Rating Scale (BPRS), as well as with a set of criteria devised by Dr. Laddis to measure the outward behavior and the mental events during behavioral crisis. The patients and the attending frontline staff will be interviewed also about their beliefs in regard to what, among the clinicians' interventions, made a difference for the course of the behavioral crisis, for better or for worse. The raters will be trained for interrater reliability and they will not be informed about the hypothesis.

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
None

入排标准

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

入选标准

  • •Diagnosed with BPD or PTSD, with a structured interview according to the current diagnostic manual
  • •In behavioral crisis

排除标准

  • •Brain damage
  • •Currently intoxicated with alcohol or drugs or in withdrawal

结局指标

主要结局

Brief Psychiatric Rating Scale (BPRS) scores

Scores on Client Observation and Client Interview, tools designed for this study

次要结局

  • Patient interview and ratings for the value of the clinicians' interventions
  • Staff interview and ratings for their own interventions

研究者

发起方
Laddis, Andreas, M.D.
申办方类型
Indiv

研究点 (1)

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