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

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Trial based cognitive therapy
Behavioral Activation
Antidepressants
Sponsored by
Hemanny, Curt, M.D.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring Major depressive disorder, Cognitive behavioral therapy, Trial based cognitive therapy, Behavioral activation

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • Curt Hemanny

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Other

Arm Label

Cognitive therapy

Behavioral Therapy

Antidepressants

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Severity of Depression
Change from baseline in severity of depression at twelve weeks. Scale used is Beck Depression Inventory (BDI).

Secondary Outcome Measures

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

Full Information

First Posted
December 2, 2015
Last Updated
March 22, 2022
Sponsor
Hemanny, Curt, M.D.
Collaborators
Federal University of Bahia
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1. Study Identification

Unique Protocol Identification Number
NCT02624102
Brief Title
Efficacy of Trial-Based Cognitive Therapy and Behavioral Activation in Treatment of Depression
Official Title
Efficacy of Trial-based Cognitive Therapy and Behavioral Activation in Treatment of Depression: a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hemanny, Curt, M.D.
Collaborators
Federal University of Bahia

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
Major depressive disorder, Cognitive behavioral therapy, Trial based cognitive therapy, Behavioral activation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
76 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cognitive therapy
Arm Type
Experimental
Arm Description
Major depressive disorder treated with cognitive therapy (Trial Based Cognitive Therapy plus Drug).
Arm Title
Behavioral Therapy
Arm Type
Experimental
Arm Description
Major depressive disorder treated with behavioral therapy (Behavioral Activation plus drug).
Arm Title
Antidepressants
Arm Type
Other
Arm Description
Major depressive disorder treated only with antidepressants (Drug alone).
Intervention Type
Behavioral
Intervention Name(s)
Trial based cognitive therapy
Other Intervention Name(s)
TBCT
Intervention Description
Patients with MDD, in use of antidepressants plus Trial Based Cognitive Therapy
Intervention Type
Behavioral
Intervention Name(s)
Behavioral Activation
Other Intervention Name(s)
BA
Intervention Description
Patients with MDD, in use of antidepressants plus Behavioral Activation
Intervention Type
Drug
Intervention Name(s)
Antidepressants
Other Intervention Name(s)
Pharmacotherapy, Control
Intervention Description
Patients with MDD, in use of antidepressants (fluoxetine, citalopram, escitalopram, bupropion, etc.) without psychotherapy.
Primary Outcome Measure Information:
Title
Severity of Depression
Description
Change from baseline in severity of depression at twelve weeks. Scale used is Beck Depression Inventory (BDI).
Time Frame
Twelve weeks (three months)
Secondary Outcome Measure Information:
Title
WHOQoL
Description
Change from baseline in quality of life at twelve weeks. The scale used is World Health Organization Quality-of-Life Scale (WHOQoL-brief)
Time Frame
Twelve weeks (three months).
Title
WHOQoL
Description
Change from baseline in quality of life at one year (follow-up). The scale used is World WHOQoL-brief.
Time Frame
One year.
Title
Cognitive Distortions
Description
Change from baseline in Cognitive Distortions at twelve weeks. The scale used is Cognitive Distortions Questionnaire (CD-Quest).
Time Frame
Twelve weeks (Three months).
Title
Cognitive Distortions
Description
Change from baseline in Cognitive Distortions at one years (follow-up). The scale used is CD-Quest.
Time Frame
One year.
Title
Disability
Description
Change from baseline in Disability at twelve weeks). The scale used is Sheehan Disability Scale.
Time Frame
twelve weeks.
Title
Disability
Description
Change from baseline in Disability at one year (follow-up). The scale used is Sheehan Disability Scale..
Time Frame
One year.
Title
Severity of Depression (BDI)
Description
Change from baseline in Disability at one year (follow-up). Scale used is BDI.
Time Frame
One year.
Title
Severity of Depression
Description
Change from baseline in severity of depression at one year (follow-up). Scale used is Hamilton Rating Scale for Depression (HRSD).
Time Frame
One year.
Title
Severity of Depression (HRSD)
Description
Change from baseline in severity of depression at twelve weeks. Scale used is HRSD.
Time Frame
Twelve weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Irismar Reis de Oliveira, Ph.D
Organizational Affiliation
Federal University of Bahia
Official's Role
Study Director
Facility Information:
Facility Name
Curt Hemanny
City
Salvador
State/Province
Bahia
ZIP/Postal Code
41815340
Country
Brazil

12. IPD Sharing Statement

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

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