Major Depressive Disorder
Conditions
Keywords
Major depressive disorder, Cognitive behavioral therapy, Trial based cognitive therapy, Behavioral activation
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.
Interventions
BEHAVIORALTrial based cognitive therapy
Patients with MDD, in use of antidepressants plus Trial Based Cognitive Therapy
BEHAVIORALBehavioral Activation
Patients with MDD, in use of antidepressants plus Behavioral Activation
DRUGAntidepressants
Patients with MDD, in use of antidepressants (fluoxetine, citalopram, escitalopram, bupropion, etc.) without psychotherapy.
Sponsors
Federal University of Bahia
Hemanny, Curt, M.D.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Severity of Depression | Twelve weeks (three months) | Change from baseline in severity of depression at twelve weeks. Scale used is Beck Depression Inventory (BDI). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cognitive Distortions | Twelve weeks (Three months). | Change from baseline in Cognitive Distortions at twelve weeks. The scale used is Cognitive Distortions Questionnaire (CD-Quest). |
| Disability | twelve weeks. | Change from baseline in Disability at twelve weeks). The scale used is Sheehan Disability Scale. |
| WHOQoL | 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) |
| Severity of Depression | One year. | 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) | Twelve weeks. | Change from baseline in severity of depression at twelve weeks. Scale used is HRSD. |
| Severity of Depression (BDI) | One year. | Change from baseline in Disability at one year (follow-up). Scale used is BDI. |
Countries
Brazil
Outcome results
None listed