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

Phase 3

Completed

• Conditions: Major Depressive Disorder
• Interventions: Behavioral: Trial based cognitive therapy; Behavioral: Behavioral Activation; Drug: Antidepressants

• Registration Number: NCT02624102
• Lead Sponsor: Hemanny, Curt, M.D.

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.

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2015-12-02
• Study First Submitted QC: 2015-12-07
• Study First Posted: 2015-12-08
• Primary Completion: 2017-12
• Study Completion: 2019-12
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-22
• Last Update Posted: 2022-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cognitive therapy	Trial based cognitive therapy	Major depressive disorder treated with cognitive therapy (Trial Based Cognitive Therapy plus Drug).
Behavioral Therapy	Behavioral Activation	Major depressive disorder treated with behavioral therapy (Behavioral Activation plus drug).
Antidepressants	Antidepressants	Major depressive disorder treated only with antidepressants (Drug alone).

Primary Outcome Measures

Name	Time	Method
Severity of Depression	Twelve weeks (three months)	Change from baseline in severity of depression at twelve weeks. Scale used is Beck Depression Inventory (BDI).

Secondary Outcome Measures

Name	Time	Method
WHOQoL	One year.	Change from baseline in quality of life at one year (follow-up). The scale used is World WHOQoL-brief.
Cognitive Distortions	One year.	Change from baseline in Cognitive Distortions at one years (follow-up). The scale used is CD-Quest.
Severity of Depression	One year.	Change from baseline in severity of depression at one year (follow-up). Scale used is Hamilton Rating Scale for Depression (HRSD).
Severity of Depression (HRSD)	Twelve weeks.	Change from baseline in severity of depression at twelve weeks. Scale used is HRSD.
Disability	One year.	Change from baseline in Disability at one year (follow-up). The scale used is Sheehan Disability Scale..
Severity of Depression (BDI)	One year.	Change from baseline in Disability at one year (follow-up). Scale used is BDI.

Trial Locations

Locations (1)

Curt Hemanny; 🇧🇷 Salvador, Bahia, Brazil