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Group Cognitive Behavioral Therapy Versus Fluoxetine for Obsessive-Compulsive Disorder: a Practical Trial (GCBTVF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00680602
Recruitment Status : Completed
First Posted : May 20, 2008
Last Update Posted : February 16, 2009
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by:
University of Sao Paulo

Brief Summary:
First line treatments fo Obsessive Compulsive Disorder (OCD) are Selective Serotonin Recapture Inhibitors (SSRIs) and Cognitive Behaviour Therapy (CBT) including exposure with response prevention. The aim of the present study is to evaluate the clinical efficacy of GCBT and SSRIs for OCD patients. Other clinical trials have compared these treatments, but with OCD patients without any other psychiatric disorder. In this study patients with current age between 18 and 65 years, with YBOCS score of at least 16 and psychiatric comorbidities will be not excluded. Exclusion criteria will be: OCD secondary to brain trauma, stroke or malformation; current abuse of alcohol or other psychoactive substance, current presence of psychotic symptoms, suicidal risk, psychiatric or clinical comorbidity that might get worse with the medications used in the trial. So, the present study investigates the efficacy of these treatments for a heterogeneous OCD population, trying to identify if the usual treatments are efficient when applied in the public health system that treat not just patients with only OCD diagnosis. Patients will be randomized for GCBT and SSRI, and after treatment will be evaluated by researchers blind to the treatment received.

Condition or disease Intervention/treatment Phase
Obsessive Compulsive Disorder Behavioral: Group Cognitive Behavior Therapy Drug: SSRI (fluoxetine, sertraline, paroxetine, citalopram) Phase 4

Detailed Description:
During the last decades, different pharmacological and psychotherapeutic strategies have been used to treat patients with obsessive compulsive disorder (OCD). Drugs that inhibit the serotonin recapture and the cognitive behavior therapy, that includes the exposure with response prevention and cognitive strategies, have been the most efficient treatment so far. This study's aims are to compare group cognitive-behavior therapy and standard pharmacological treatment (SRIs) in a world real population, using broader inclusion criteria. DSM-IV diagnostic criteria for OCD will be used (APA, 1994) and patients will be interviewed with the following instruments: SCID-I and Y-BOCS. Inclusion criteria are: (1) OCD diagnosis, (2) YBOCS score ≥ 16 (for patients with both obsessions and compulsions) or ≥ 10 (for patients with only obsessions or compulsions), (3) informed consent to participate in this clinical trial. Exclusion criteria are: (1) patients with clinical or neurological diseases that may be worsen by the medications included in treatment protocol, (2) Current substance dependence, (3) Current psychotic symptoms, (4) Current suicide risk. Patients will be randomized in blocks of 12 and with stratification for the following parameters: current SSRI, age, sex and previous response to treatment. Rates of improvement will be based on the results of the YBOCS scores for obsessions and compulsions and on the results of the clinical global impression scale. Pos-treatment measures will be assessed by psychiatrists or psychologists not involved in the patients treatment that will be blind for the treatment being received by the patient. The patient will be considered responsive to treatment when he or she presents a reduction in YBOCS score ≥ 35% of the initial score and a CGI score of 1 (very much improved) or 2 (much improved). The results of this study will help us to identify better health politics planning to a heterogeneous OCD population. So, it will improve our knowledge about the efficacy of the first line treatments in a real world OCD population.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 158 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Group Cognitive Behavioral Therapy Versus Fluoxetine for Obsessive-Compulsive Disorder: a Randomized Open Trial for Any Patient.
Study Start Date : January 2006
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
Group Cognitive Behavior Therapy
Behavioral: Group Cognitive Behavior Therapy
Structured protocol described by Cordioli et al., 2003
Other Names:
  • behavior therapy
  • CBT
  • group psychotherapy

Active Comparator: 2
Selective Serotonin Reuptake Inhibitor
Drug: SSRI (fluoxetine, sertraline, paroxetine, citalopram)
Fluoxetine (80mg/day or maximum tolerated dosage) Sertraline (200mg/day or maximum tolerated dosage) Paroxetine (60 mg/day or maximum tolerated dosage) Citalopram (60 mg/day or maximum tolerated dosage)
Other Names:
  • Prozac
  • Zoloft
  • Paxil
  • Cipramil

Primary Outcome Measures :
  1. Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) (Goodman et al., 1989) and Clinical Global Impressions (CGI) (Guy, 1976) will be implemented at pre and post treatment by a blind evaluator to the treatment received. [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Quality of life measured by SF 36 and social adjustment measured by EAS. [ Time Frame: 12 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Having been diagnosed with primary OCD according to the criteria set forth in the DSM-IV;
  • Current symptoms causing significant distress (YBOCS score greater than 16);
  • Not receiving current adequate treatment;
  • Accepting to participate in the study

Exclusion Criteria:

  • Having a clinical or neurological disease that might be worsened by the medicines included in the treatment protocol;
  • Presenting current substance dependence or abuse;
  • Exhibiting current psychotic symptoms; being currently at risk for suicide;
  • And, being pregnant or having the intention to become pregnant prior to the end of the treatment protocol

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00680602

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Institute of Psychiatry, Clinics Hospital, University of São Paulo Medical School
São Paulo, SP, Brazil, 05403-010
Sponsors and Collaborators
University of Sao Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
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Principal Investigator: Cristina B Silva, Psychologist University of São Paulo

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Cristina Belotto da Silva, Department & Institute of Psychiatry, Clinical Hospital, University of São Paulo Identifier: NCT00680602    
Other Study ID Numbers: 06/50829-8
First Posted: May 20, 2008    Key Record Dates
Last Update Posted: February 16, 2009
Last Verified: February 2009
Keywords provided by University of Sao Paulo:
behavior therapy
group therapy
Additional relevant MeSH terms:
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Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Personality Disorders
Mental Disorders
Anxiety Disorders
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Antiparkinson Agents
Anti-Dyskinesia Agents
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists