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| Name | Class |
|---|---|
| Federal University of Bahia | OTHER |
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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,
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive therapy | Experimental | Major depressive disorder treated with cognitive therapy (Trial Based Cognitive Therapy plus Drug). |
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| Behavioral Therapy | Experimental | Major depressive disorder treated with behavioral therapy (Behavioral Activation plus drug). |
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| Antidepressants | Other | Major depressive disorder treated only with antidepressants (Drug alone). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trial based cognitive therapy | Behavioral | Patients with MDD, in use of antidepressants plus Trial Based Cognitive Therapy |
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| Measure | Description | Time Frame |
|---|---|---|
| Severity of Depression | Change from baseline in severity of depression at twelve weeks. Scale used is Beck Depression Inventory (BDI). | Twelve weeks (three months) |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| WHOQoL | Change from baseline in quality of life at one year (follow-up). The scale used is World WHOQoL-brief. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Irismar Reis de Oliveira, Ph.D | Federal University of Bahia | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Curt Hemanny | Salvador | Estado de Bahia | 41815340 | Brazil |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000928 | Antidepressive Agents |
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D011619 | Psychotropic Drugs |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
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| Behavioral Activation | Behavioral | Patients with MDD, in use of antidepressants plus Behavioral Activation |
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| Antidepressants | Drug | Patients with MDD, in use of antidepressants (fluoxetine, citalopram, escitalopram, bupropion, etc.) without psychotherapy. |
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| One year. |
| Cognitive Distortions | Change from baseline in Cognitive Distortions at twelve weeks. The scale used is Cognitive Distortions Questionnaire (CD-Quest). | Twelve weeks (Three months). |
| Cognitive Distortions | Change from baseline in Cognitive Distortions at one years (follow-up). The scale used is CD-Quest. | One year. |
| Disability | Change from baseline in Disability at twelve weeks). The scale used is Sheehan Disability Scale. | twelve weeks. |
| Disability | Change from baseline in Disability at one year (follow-up). The scale used is Sheehan Disability Scale.. | One year. |
| Severity of Depression (BDI) | Change from baseline in Disability at one year (follow-up). Scale used is BDI. | One year. |
| 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. |
| Severity of Depression (HRSD) | Change from baseline in severity of depression at twelve weeks. Scale used is HRSD. | Twelve weeks. |
| D020164 | Chemical Actions and Uses |
| D013812 | Therapeutics |