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,
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
76
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.
Curt Hemanny
Salvador, Estado de Bahia, Brazil
Severity of Depression
Change from baseline in severity of depression at twelve weeks. Scale used is Beck Depression Inventory (BDI).
Time frame: Twelve weeks (three months)
WHOQoL
Change from baseline in quality of life at twelve weeks. The scale used is World Health Organization Quality-of-Life Scale (WHOQoL-brief)
Time frame: Twelve weeks (three months).
WHOQoL
Change from baseline in quality of life at one year (follow-up). The scale used is World WHOQoL-brief.
Time frame: One year.
Cognitive Distortions
Change from baseline in Cognitive Distortions at twelve weeks. The scale used is Cognitive Distortions Questionnaire (CD-Quest).
Time frame: Twelve weeks (Three months).
Cognitive Distortions
Change from baseline in Cognitive Distortions at one years (follow-up). The scale used is CD-Quest.
Time frame: One year.
Disability
Change from baseline in Disability at twelve weeks). The scale used is Sheehan Disability Scale.
Time frame: twelve weeks.
Disability
Change from baseline in Disability at one year (follow-up). The scale used is Sheehan Disability Scale..
Time frame: One year.
Severity of Depression (BDI)
Change from baseline in Disability at one year (follow-up). Scale used is BDI.
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Time frame: One year.
Severity of Depression
Change from baseline in severity of depression at one year (follow-up). Scale used is Hamilton Rating Scale for Depression (HRSD).
Time frame: One year.
Severity of Depression (HRSD)
Change from baseline in severity of depression at twelve weeks. Scale used is HRSD.
Time frame: Twelve weeks.