Efficacy of Trial-Based Cognitive Therapy and Behavioral Activation in Treatment of Depression
Condition: Major Depressive Disorder
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      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,
    

Detailed description: 
      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.
    

Intervention name(s): Trial based cognitive therapy; Behavioral Activation; Antidepressants
Intervention type(s): Behavioral; Behavioral; Drug
Intervention description(s): Patients with MDD, in use of antidepressants plus Trial Based Cognitive Therapy; Patients with MDD, in use of antidepressants plus Behavioral Activation; Patients with MDD, in use of antidepressants (fluoxetine, citalopram, escitalopram, bupropion, etc.) without psychotherapy.
Other intervention name(s): TBCT; BA; Pharmacotherapy, Control
Intervention MeSH terms: Antidepressive Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Major depressive disorder; Cognitive behavioral therapy; Trial based cognitive therapy; Behavioral activation