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

Major Depressive Disorder Clinical Trial

Official title:

Efficacy of Trial-based Cognitive Therapy and Behavioral Activation in Treatment of Depression: a Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02624102
• Other study ID #: CAAE 44663315.4.0000.5662
• Status: Completed
• Phase: Phase 3
• Start date: September 2015
• Est. completion date: December 2019

Study information

• Verified date: March 2022
• Source: Hemanny, Curt, M.D.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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,

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: December 2019
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Behavioral:
• Trial based cognitive therapy
Patients with MDD, in use of antidepressants plus Trial Based Cognitive Therapy
• Behavioral Activation
Patients with MDD, in use of antidepressants plus Behavioral Activation

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

Locations

Country	Name	City	State
Brazil	Curt Hemanny	Salvador	Bahia

Sponsors (2)

Lead Sponsor	Collaborator
Hemanny, Curt, M.D.	Federal University of Bahia

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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).
Secondary	WHOQoL	Change from baseline in quality of life at one year (follow-up). The scale used is World WHOQoL-brief.	One year.
Secondary	Cognitive Distortions	Change from baseline in Cognitive Distortions at twelve weeks. The scale used is Cognitive Distortions Questionnaire (CD-Quest).	Twelve weeks (Three months).
Secondary	Cognitive Distortions	Change from baseline in Cognitive Distortions at one years (follow-up). The scale used is CD-Quest.	One year.
Secondary	Disability	Change from baseline in Disability at twelve weeks). The scale used is Sheehan Disability Scale.	twelve weeks.
Secondary	Disability	Change from baseline in Disability at one year (follow-up). The scale used is Sheehan Disability Scale..	One year.
Secondary	Severity of Depression (BDI)	Change from baseline in Disability at one year (follow-up). Scale used is BDI.	One year.
Secondary	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.
Secondary	Severity of Depression (HRSD)	Change from baseline in severity of depression at twelve weeks. Scale used is HRSD.	Twelve weeks.