Efficacy of Trial-Based Cognitive Therapy and Behavioral Activation in Treatment of Depression

Hemanny, Curt, M.D.

Status and phase: Completed; Phase 3

Conditions: Major Depressive Disorder

Treatments: Behavioral: Behavioral Activation; Behavioral: Trial based cognitive therapy; Drug: Antidepressants

Study type: Interventional

Funder types: Other

Identifiers

NCT02624102

CAAE 44663315.4.0000.5662

Details and patient eligibility

About

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,

Full 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.

Enrollment: 76 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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76 participants in 3 patient groups

Cognitive therapy

Experimental group

Description:

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

Treatment:

Behavioral: Trial based cognitive therapy

Behavioral Therapy

Experimental group

Description:

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

Treatment:

Behavioral: Behavioral Activation

Antidepressants

Other group

Description:

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

Treatment:

Drug: Antidepressants