Title
Efficacy of Trial-Based Cognitive Therapy and Behavioral Activation in Treatment of Depression
Efficacy of Trial-based Cognitive Therapy and Behavioral Activation in Treatment of Depression: a Randomized Clinical Trial
Phase
Phase 3Lead Sponsor
Hemanny, Curt, M.D.Study Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Major Depressive DisorderIntervention/Treatment
paroxetine citalopram sertraline trazodone venlafaxine maprotiline ...Study Participants
76Major 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,
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.
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.
Major depressive disorder treated with cognitive therapy (Trial Based Cognitive Therapy plus Drug).
Major depressive disorder treated with behavioral therapy (Behavioral Activation plus drug).
Major depressive disorder treated only with antidepressants (Drug alone).
Inclusion Criteria: Major Depressive Disorder Both Genres Minimum of 20 in BDI Score Refractory depressive disorder Exclusion Criteria: Bipolar disorder High risk of suicide Borderline personality