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Completed

NCT Number: NCT02624102

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

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,

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Curt Hemanny

Salvador, Estado de Bahia, 41815340, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Trial based cognitive therapy

Behavioral

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

Other names: TBCT

Behavioral Activation

Behavioral

Patients with MDD, in use of antidepressants plus Behavioral Activation

Other names: BA

Antidepressants

Drug

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

Other names: Pharmacotherapy, Control

Primary outcomes

  1. Severity of Depression

    Time frame: Twelve weeks (three months)

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

Secondary outcomes

  1. WHOQoL

    Time frame: Twelve weeks (three months).

    Change from baseline in quality of life at twelve weeks. The scale used is World Health Organization Quality-of-Life Scale (WHOQoL-brief)

  2. WHOQoL

    Time frame: One year.

    Change from baseline in quality of life at one year (follow-up). The scale used is World WHOQoL-brief.

  3. Cognitive Distortions

    Time frame: Twelve weeks (Three months).

    Change from baseline in Cognitive Distortions at twelve weeks. The scale used is Cognitive Distortions Questionnaire (CD-Quest).

  4. Cognitive Distortions

    Time frame: One year.

    Change from baseline in Cognitive Distortions at one years (follow-up). The scale used is CD-Quest.

  5. Disability

    Time frame: twelve weeks.

    Change from baseline in Disability at twelve weeks). The scale used is Sheehan Disability Scale.

  6. Disability

    Time frame: One year.

    Change from baseline in Disability at one year (follow-up). The scale used is Sheehan Disability Scale..

  7. Severity of Depression (BDI)

    Time frame: One year.

    Change from baseline in Disability at one year (follow-up). Scale used is BDI.

  8. Severity of Depression

    Time frame: One year.

    Change from baseline in severity of depression at one year (follow-up). Scale used is Hamilton Rating Scale for Depression (HRSD).

  9. Severity of Depression (HRSD)

    Time frame: Twelve weeks.

    Change from baseline in severity of depression at twelve weeks. Scale used is HRSD.

Sponsors and collaborators

Lead sponsor

Hemanny, Curt, M.D.

Indiv

Collaborators

  • Federal University of Bahia

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2019
First posted
Dec 8, 2015
Registry last updated
Apr 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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