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临床试验/NCT00970437
NCT00970437已完成不适用

A Comparison of Cognitive Behavioral Analysis System of Psychotherapy (CBASP) and System of Supportive Psychotherapy (SYSP) for Early Onset Chronic Depression

University Hospital Freiburg2 个研究点 分布在 1 个国家目标入组 268 人开始时间: 2010年4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
268
试验地点
2
主要终点
Depressive symptoms as measured by the HRSD (24-item Hamilton Rating Scale of Depression)

研究概览

简要总结

The purpose of this study is to compare the efficacy of the Cognitive Behavioural Analysis System of Psychotherapy (CBASP) with the non-specific System of Supportive Psychotherapy (SYSP)in early onset chronically depressives.

详细描述

Effective treatment strategies for chronic depression are urgently needed since it is not only a common and particularly disabling disorder, but is also considered treatment resistant by most clinicians. There are only a few studies on chronic depression indicating that traditional interventions are not as effective as in acute, episodic depression. In addition, most of the studies had methodological weaknesses, such as the very short courses of psychotherapy. Usually, chronic depression begins early in life, is often associated with early interpersonal trauma, and results in an even more substantial human capital loss than the late-onset group. Furthermore, it shows a weak response to medication and a high rate of relapse after an initial response. With the present multicentre study, the efficacy of the only specific psychotherapy for chronic depression (Cognitive Behavioural Analysis System of Psychotherapy/CBASP) is compared with a non-specific System of Supportive Psychotherapy/SYSP in early onset chronically depressives. CBASP faired very well in one large trial but has never been directly compared to a non-specific psychotherapeutic control. Another innovative aspect of the study is the use of an extended course of psychotherapy (32 sessions). Primary hypothesis: CBASP is more effective in reducing depressive symptoms than SYSP.

A naturalistic study following up the patients of the trial up to two years after termination of the study treatments is performed in order to investigate the long-term effectiveness of CBASP compared to the System of Supportive Psychotherapy. The primary outcome of this follow-up study is the rate of well-weeks (weeks with no or minimal depression symptoms) during the two years after termination of the study treatments as measured with the Longitudinal Interval Follow-up Evaluation (LIFE) Interview

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 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • DSM-IV criteria for a current episode of chronic MDD, MDD superimposed on a pre-existing dysthymic disorder or recurrent MDD with incomplete remission between episodes in a patient with a current MDD and a total duration of at least 2 years.
  • Early onset of the disorder according to DSM-IV (onset before the age of 21)
  • Age between 18 and 65
  • A score of at least 20 on the 24-item HRSD at screening and, after a 2-week drug-free period, at baseline
  • Fluent in German language
  • Provide informed consent

排除标准

  • Acute risk for suicide (as opposed to suicidal thoughts) assessed according to clinical practice guidelines. Suicidal patients are eligible, as long as outpatient treatment is deemed safe by the clinician.
  • A history of psychotic symptoms, bipolar disorder, or organic brain disorders
  • A primary diagnosis of another axis I disorder including anxiety disorders (e.g. Posttraumatic Stress Disorder), or any severe substance-related abuse or dependence disorder as evaluated with the SCID-I
  • Antisocial, schizotypical, or borderline personality disorder (SCID-II);
  • Severe cognitive impairment
  • Absence of a response to previous adequate trial of CBASP, and/or SYSP
  • Other ongoing psychotherapy or medication
  • A serious medical condition (i.e. a history of seizures, severe head trauma, stroke or heart attack within six months before the study began)

结局指标

主要结局

Depressive symptoms as measured by the HRSD (24-item Hamilton Rating Scale of Depression)

时间窗: 20 weeks after randomization (after acute treatment phase)

次要结局

未报告次要终点

研究者

发起方
University Hospital Freiburg
申办方类型
Other
责任方
Principal Investigator
主要研究者

Elisabeth Schramm

PhD

University Hospital Freiburg

研究点 (2)

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