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临床试验/NCT03022071
NCT03022071已完成不适用

What Works for Whom and How? Mechanisms of Change in Psychotherapy

Oslo University Hospital2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2017年2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
100
试验地点
2
主要终点
Hamilton Depression Rating Scale

研究概览

简要总结

Background: Major depressive disorder (MDD) is a prevalent psychiatric condition associated with significant disability, mortality and economic burden. MDD is ranked fourth in terms of disease burden as defined by the World Health Organization (2001). Cognitive Behavioral Therapy (CBT) and Psychodynamic Psychotherapy (PDT) are found to be equally effective for patients with depression. However, many patients do not respond sufficiently to treatment and relapse rates are high. To be able to offer individualized treatment, a clinically important question is therefore whether some patients profit more from one of the two therapies. At present little is known on which patient characteristics (moderators) may be associated with differential outcomes of CBT and PDT and through what kind of therapeutic processes and mechanisms (mediators) improvements occur in each therapy mode. There are actually only theoretical assumptions sparsely supported by research findings on what moderates and mediates the treatment effects of CBT and PDT.

Aims: The overall aim of this project is to examine putative moderators and mediators in CBT and PDT and develop more basic knowledge about their impact on outcomes of psychotherapy for patients with MDD.

Methods and study design: The study is a randomized clinical trial. One hundred patients will be randomized to one of two treatment conditions. The patients will be treated over 28 weeks with either CBT (one weekly session over 16 weeks and 3 booster sessions (monthly) during the rest of the 28 week study period) or PDT (one weekly session in 28 weeks). The patients will be evaluated at baseline, during therapy, at the end of therapy, and at follow-up investigations 1 and 3 years after treatment termination. The outcome measures comprise a large range of clinical and process variables, including assessment tools measuring specific preselected putative moderators and mediators.

Discussion: The clinical outcome of this trial may guide clinicians to decide what kind of treatment should be offered the individual patient. Moreover, it will shed light on what kind of mechanisms in psychotherapy that is followed by symptom improvement and increased psychosocial functioning.

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)

盲法说明

Outcome assessments will be provided by raters blinded to the randomization

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

  • Patients aged between 18-65 years, with depressive disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV; American Psychiatric Association, 2000) unipolar MDD diagnosis will be included.MINI plus (Sheehan et al., 1998 will be used as assessment tool. Comorbidity is expected to be frequent. Written consent will be obtained from all patients.
  • The participants need to have the ability to speak and understand a Scandinavian language, and willingness and ability to give informed consent.

排除标准

  • Current or past neurological illness, traumatic brain injury, current alcohol and/or substance dependency disorders, psychotic disorders, developmental disorders, and mental retardation.

结局指标

主要结局

Hamilton Depression Rating Scale

时间窗: Change in scores between baseline and 28 weeks (end of therapy) and change between baseline and one and three year follow-up

Assessment of depression

Beck Depression Index

时间窗: Change in scores between baseline and 28 weeks (end of therapy) and change between baseline and one and three year follow-up

Assessment of depression

次要结局

  • Inventory of Interpersonal Problems(Change in scores during therapy and the follow-up periode (one and three years))
  • Dysfunctional Attitude Scale(Change in scores during therapy and the follow-up periode (8 weeks, 16 weeks, 28 weeks, 1 year and 3 year follow up))
  • Metacognitive questionnaire(Change in scores during therapy and the follow-up periode (8 weeks, 16 weeks, 28 weeks, 1 year and 3 year follow up))
  • Psychodynamic Functioning Scale(Change in scores during therapy and the follow-up periode (one and three years))
  • Global Assesment of Functioning(Change in scores during therapy and the follow-up periode (one and three years))
  • Reflective functioning - depression(Change in scores during therapy and the follow-up periode (one and three years))
  • Beck Cognitive Insight Score(Change in scores during therapy and the follow-up periode (8 weeks, 16 weeks, 28 weeks, 1 year and 3 year follow up))

研究者

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

Jan Ivar Røssberg, MD

Professor MD PhD

Oslo University Hospital

研究点 (2)

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