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临床试验/NCT02624102
NCT02624102已完成3 期

Efficacy of Trial-based Cognitive Therapy and Behavioral Activation in Treatment of Depression: a Randomized Clinical Trial

Hemanny, Curt, M.D.1 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2015年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
76
试验地点
1
主要终点
Severity of Depression

研究概览

简要总结

Major Depressive Disorder (MDD) is a mood disorder, highly prevalent in Brazil and in world. The treatments of choice are the psychotropic drugs of the class of antidepressants and Behavioral or Cognitive Behavior Therapy (CBT). The aim of this study is to compare the efficacy of Trial Based Cognitive Therapy with the Behavioral Activation and pharmacotherapy in the treatment of MDD in a randomized clinical trial witch 96 patients with MDD,

详细描述

Major Depressive Disorder (MDD) is a mood disorder, highly prevalent in Brazil and in world. MDD is associated with an impaired quality of life and socio occupational functions. The treatments of choice are the psychotropic drugs of the class of antidepressants and Cognitive Behavior Therapy (CBT). Some of the patients with pharmacotherapy alone still symptomatic. This explains the association between psychotherapy and pharmacotherapy. The CBT seek to modify thoughts, emotions and behaviors and have shown efficacy in several mental disorders, including MDD. Among the CBT models, there is an emphasis on interventions that emphasize: 1) the modification or restructuring of thoughts and beliefs. In this point, the Trial based cognitive Therapy (TBCP) is an approach with a particular emphasis on the modification of core beliefs ; 2) the direct modification of behavior, such as the behavioral activation (BA) that analyzes contingencies and encourages the implementation of activities to improve mood. This project aims to compare the efficacy of TBCP with the BA in the treatment of MDD. For this, a randomized clinical trial will be conducted to treat 96 patients with MDD who are in drug treatment, which will be drawn to the interventions of TBCP most psychiatric drugs, BA more psychiatric drugs or pharmacotherapy alone, each group with 32 patients. Patients will be evaluated with scales and inventories to assess depression, quality of life and social functioning, and the data will be statistically compared between groups.

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
Triple (Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Major Depressive Disorder
  • Both Genres
  • Minimum of 20 in BDI Score
  • Refractory depressive disorder

排除标准

  • Bipolar disorder
  • High risk of suicide
  • Borderline personality

研究组 & 干预措施

Antidepressants

Other

Major depressive disorder treated only with antidepressants (Drug alone).

干预措施: Antidepressants (Drug)

Cognitive therapy

Experimental

Major depressive disorder treated with cognitive therapy (Trial Based Cognitive Therapy plus Drug).

干预措施: Trial based cognitive therapy (Behavioral)

Behavioral Therapy

Experimental

Major depressive disorder treated with behavioral therapy (Behavioral Activation plus drug).

干预措施: Behavioral Activation (Behavioral)

结局指标

主要结局

Severity of Depression

时间窗: Twelve weeks (three months)

Change from baseline in severity of depression at twelve weeks. Scale used is Beck Depression Inventory (BDI).

次要结局

  • WHOQoL(One year.)
  • Cognitive Distortions(One year.)
  • Severity of Depression(One year.)
  • Severity of Depression (HRSD)(Twelve weeks.)
  • Disability(One year.)
  • Severity of Depression (BDI)(One year.)

研究者

发起方
Hemanny, Curt, M.D.
申办方类型
Indiv
责任方
Principal Investigator
主要研究者

Curt Hemanny

Principal Investigator

Hemanny, Curt, M.D.

研究点 (1)

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