Clinical trial NCT02624102: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Major Depressive Disorder
Keywords: Major depressive disorder
Cognitive behavioral therapy
Trial based cognitive therapy
Behavioral activation
Lead sponsor: Hemanny, Curt, M.D.
Sponsor class: INDIV
Collaborators: name: Federal University of Bahia
First posted: 2015-12-08
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Severity of Depression
timeFrame: Twelve weeks (three months)
Secondary outcomes:
measure: WHOQoL
timeFrame: Twelve weeks (three months).
measure: WHOQoL
timeFrame: One year.
measure: Cognitive Distortions
timeFrame: Twelve weeks (Three months).
measure: Cognitive Distortions
timeFrame: One year.
measure: Disability
timeFrame: twelve weeks.
measure: Disability
timeFrame: One year.
measure: Severity of Depression (BDI)
timeFrame: One year.
measure: Severity of Depression
timeFrame: One year.
measure: Severity of Depression (HRSD)
timeFrame: Twelve weeks.
Other outcomes:
Locations:
city: Salvador
country: Brazil
facility: Curt Hemanny
state: Bahia
Study officials:
affiliation: Federal University of Bahia
name: Irismar Reis de Oliveira, Ph.D
role: STUDY_DIRECTOR
References: