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

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,

Study Overview

• Status: Completed
• Conditions: Major Depressive Disorder
• Intervention / Treatment: Behavioral: Trial based cognitive therapy; Behavioral: Behavioral Activation; Drug: Antidepressants

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 Type: Interventional
• Enrollment (Actual): 76
• Phase: Phase 3

Contacts and Locations

Study Locations

• Brazil
  • Bahia
    • Salvador, Bahia, Brazil, 41815340
      • Curt Hemanny

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cognitive therapy; Major depressive disorder treated with cognitive therapy (Trial Based Cognitive Therapy plus Drug).	Behavioral: Trial based cognitive therapy; Patients with MDD, in use of antidepressants plus Trial Based Cognitive Therapy; Other Names: TBCT
Experimental: Behavioral Therapy; Major depressive disorder treated with behavioral therapy (Behavioral Activation plus drug).	Behavioral: Behavioral Activation; Patients with MDD, in use of antidepressants plus Behavioral Activation; Other Names: BA
Other: Antidepressants; Major depressive disorder treated only with antidepressants (Drug alone).	Drug: Antidepressants; Patients with MDD, in use of antidepressants (fluoxetine, citalopram, escitalopram, bupropion, etc.) without psychotherapy.; Other Names: Pharmacotherapy, Control

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
WHOQoL	Change from baseline in quality of life at twelve weeks. The scale used is World Health Organization Quality-of-Life Scale (WHOQoL-brief)	Twelve weeks (three months).
WHOQoL	Change from baseline in quality of life at one year (follow-up). The scale used is World WHOQoL-brief.	One year.
Cognitive Distortions	Change from baseline in Cognitive Distortions at twelve weeks. The scale used is Cognitive Distortions Questionnaire (CD-Quest).	Twelve weeks (Three months).
Cognitive Distortions	Change from baseline in Cognitive Distortions at one years (follow-up). The scale used is CD-Quest.	One year.
Disability	Change from baseline in Disability at twelve weeks). The scale used is Sheehan Disability Scale.	twelve weeks.
Disability	Change from baseline in Disability at one year (follow-up). The scale used is Sheehan Disability Scale..	One year.
Severity of Depression (BDI)	Change from baseline in Disability at one year (follow-up). Scale used is BDI.	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).	One year.
Severity of Depression (HRSD)	Change from baseline in severity of depression at twelve weeks. Scale used is HRSD.	Twelve weeks.

Collaborators and Investigators

• Sponsor: Hemanny, Curt, M.D.
• Collaborators: Federal University of Bahia
• Investigators: Study Director: Irismar Reis de Oliveira, Ph.D, Federal University of Bahia

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): December 1, 2019

Study Registration Dates

• First Submitted: December 2, 2015
• First Submitted That Met QC Criteria: December 7, 2015
• First Posted (Estimate): December 8, 2015

Study Record Updates

• Last Update Posted (Actual): April 4, 2022
• Last Update Submitted That Met QC Criteria: March 22, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Cognitive behavioral therapy; Major depressive disorder; Behavioral activation; Trial based cognitive therapy
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major; Psychotropic Drugs; Antidepressive Agents
• Other Study ID Numbers: CAAE 44663315.4.0000.5662