Major Depressive DisorderPhase 3NCT02624102
Efficacy of Trial-Based Cognitive Therapy and Behavioral Activation in Treatment of Depression
A Phase 3 study testing Trial based cognitive therapy, Behavioral Activation and Antidepressants in people with Major Depressive Disorder, run by Hemanny, Curt, M.D. at 1 site in Brazil.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Trial based cognitive therapy, Behavioral Activation and Antidepressants
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteBrazil
- Study dates
- Sep 2015to Dec 2019
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Major Depressive Disorder
- Both Genres
- Minimum of 20 in BDI Score
- Refractory depressive disorder
Who cannot join
- Bipolar disorder
- High risk of suicide
- Borderline personality
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Trial-based Cognitive Therapy and Behavioral Activation in Treatment of Depression: a Randomized Clinical Trial
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,
Read the 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.
- Conditions
- Major Depressive Disorder
- Being tested
- Trial based cognitive therapy, Behavioral Activation, Antidepressants
- Keywords
- Major depressive disorder, Cognitive behavioral therapy, Trial based cognitive therapy, Behavioral activation
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trial based cognitive therapyBehavioural
Also called TBCT
Patients with MDD, in use of antidepressants plus Trial Based Cognitive Therapy
Behavioral ActivationBehavioural
Also called BA
Patients with MDD, in use of antidepressants plus Behavioral Activation
AntidepressantsDrug
Also called Pharmacotherapy, Control
Patients with MDD, in use of antidepressants (fluoxetine, citalopram, escitalopram, bupropion, etc.) without psychotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive therapy | Experimental | Major depressive disorder treated with cognitive therapy (Trial Based Cognitive Therapy plus Drug). Receives: Behavioral: Trial based cognitive therapy |
| Behavioral Therapy | Experimental | Major depressive disorder treated with behavioral therapy (Behavioral Activation plus drug). Receives: Behavioral: Behavioral Activation |
| Antidepressants | Other | Major depressive disorder treated only with antidepressants (Drug alone). Receives: Drug: Antidepressants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of Depression
Change from baseline in severity of depression at twelve weeks. Scale used is Beck Depression Inventory (BDI).
Measured: Twelve weeks (three months)
Secondary outcomes (9)
WHOQoL
Change from baseline in quality of life at twelve weeks. The scale used is World Health Organization Quality-of-Life Scale (WHOQoL-brief)
Measured: Twelve weeks (three months).
WHOQoL
Change from baseline in quality of life at one year (follow-up). The scale used is World WHOQoL-brief.
Measured: One year.
Cognitive Distortions
Change from baseline in Cognitive Distortions at twelve weeks. The scale used is Cognitive Distortions Questionnaire (CD-Quest).
Measured: Twelve weeks (Three months).
Cognitive Distortions
Change from baseline in Cognitive Distortions at one years (follow-up). The scale used is CD-Quest.
Measured: One year.
Disability
Change from baseline in Disability at twelve weeks). The scale used is Sheehan Disability Scale.
Measured: twelve weeks.
Disability
Change from baseline in Disability at one year (follow-up). The scale used is Sheehan Disability Scale..
Measured: One year.
Severity of Depression (BDI)
Change from baseline in Disability at one year (follow-up). Scale used is BDI.
Measured: 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).
Measured: One year.
Severity of Depression (HRSD)
Change from baseline in severity of depression at twelve weeks. Scale used is HRSD.
Measured: Twelve weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2015 (estimated)
- Study startSep 2015
- Primary completionDec 2017
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hemanny, Curt, M.D.
- Collaborators
- Federal University of Bahia
- Responsible party
- Principal investigator, Curt Hemanny, Hemanny, Curt, M.D.
- Investigators
- Irismar Reis de Oliveira, Ph.D, Study director, Federal University of Bahia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02624102
- Sponsor's protocol ID
- CAAE 44663315.4.0000.5662
- Status last verified
- Mar 2022
- First submitted
- 2 Dec 2015
- Last updated
- 4 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Trial-based Cognitive Therapy and Behavioral Activation in Treatment of Depression: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02624102
- Acronym / sponsor ID
- CAAE 44663315.4.0000.5662
- Conditions
- Major Depressive Disorder
- Keywords
- Major depressive disorder, Cognitive behavioral therapy, Trial based cognitive therapy, Behavioral activation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Hemanny, Curt, M.D.
- Collaborators
- Federal University of Bahia
- Study start
- Sep 2015
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 8 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cognitive therapy | Experimental | Behavioral: Trial based cognitive therapyMajor depressive disorder treated with cognitive therapy (Trial Based Cognitive Therapy plus Drug). |
| Behavioral Therapy | Experimental | Behavioral: Behavioral ActivationMajor depressive disorder treated with behavioral therapy (Behavioral Activation plus drug). |
| Antidepressants | Other | Drug: AntidepressantsMajor depressive disorder treated only with antidepressants (Drug alone). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Major Depressive Disorder
- Both Genres
- Minimum of 20 in BDI Score
- Refractory depressive disorder
Key exclusion criteria (3 listed)
- Bipolar disorder
- High risk of suicide
- Borderline personality
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trial based cognitive therapyAlso: TBCTPatients with MDD, in use of antidepressants plus Trial Based Cognitive Therapy | Behavioural | Cognitive therapy |
| Behavioral ActivationAlso: BAPatients with MDD, in use of antidepressants plus Behavioral Activation | Behavioural | Behavioral Therapy |
| AntidepressantsAlso: Pharmacotherapy, ControlPatients with MDD, in use of antidepressants (fluoxetine, citalopram, escitalopram, bupropion, etc.) without psychotherapy. | Drug | Antidepressants |
Primary outcome
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).
9 secondary outcomes
WHOQoL
Time frame: Twelve weeks (three months).
WHOQoL
Time frame: One year.
Cognitive Distortions
Time frame: Twelve weeks (Three months).
Cognitive Distortions
Time frame: One year.
Disability
Time frame: twelve weeks.
Disability
Time frame: One year.
Severity of Depression (BDI)
Time frame: One year.
Severity of Depression
Time frame: One year.
Severity of Depression (HRSD)
Time frame: Twelve weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Irismar Reis de Oliveira, Ph.D study director
Federal University of Bahia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Trial based cognitive therapy, Behavioral Activation and Antidepressants in people with Major Depressive Disorder, run by Hemanny, Curt, M.D. at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity of Depression (time frame: Twelve weeks (three months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2022.