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

NCT ID: NCT02624102

Last Updated: 2022-04-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2019-12-31

Brief 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.

Conditions

Major Depressive Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Cognitive therapy

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

Group Type: EXPERIMENTAL

Trial based cognitive therapy

Intervention Type: BEHAVIORAL

Patients with MDD, in use of antidepressants plus Trial Based Cognitive Therapy

Behavioral Therapy

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

Group Type: EXPERIMENTAL

Behavioral Activation

Intervention Type: BEHAVIORAL

Patients with MDD, in use of antidepressants plus Behavioral Activation

Antidepressants

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

Group Type: OTHER

Antidepressants

Intervention Type: DRUG

Patients with MDD, in use of antidepressants (fluoxetine, citalopram, escitalopram, bupropion, etc.) without psychotherapy.

Interventions

Trial based cognitive therapy

Patients with MDD, in use of antidepressants plus Trial Based Cognitive Therapy

Intervention Type: BEHAVIORAL

Behavioral Activation

Patients with MDD, in use of antidepressants plus Behavioral Activation

Intervention Type: BEHAVIORAL

Antidepressants

Patients with MDD, in use of antidepressants (fluoxetine, citalopram, escitalopram, bupropion, etc.) without psychotherapy.

Intervention Type: DRUG

Other Intervention Names

TBCT; BA; Pharmacotherapy, Control

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federal University of Bahia

OTHER

Sponsor Role: collaborator

Hemanny, Curt, M.D.

INDIV

Sponsor Role: lead

Responsible Party

Curt Hemanny

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Irismar Reis de Oliveira, Ph.D

Role: STUDY_DIRECTOR

Federal University of Bahia

Locations

Curt Hemanny

Salvador, Estado de Bahia, Brazil

Countries

Brazil

Other Identifiers

CAAE 44663315.4.0000.5662

Identifier Type: -

Identifier Source: org_study_id