Group Cognitive Behavioral Therapy Versus Fluoxetine for Obsessive-Compulsive Disorder: a Practical Trial (GCBTVF)
Primary Purpose
Obsessive Compulsive Disorder
Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Group Cognitive Behavior Therapy
SSRI (fluoxetine, sertraline, paroxetine, citalopram)
Sponsored by
About this trial
This is an interventional health services research trial for Obsessive Compulsive Disorder focused on measuring behavior therapy, group therapy, psychopharmacology
Eligibility Criteria
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
Sites / Locations
- Institute of Psychiatry, Clinics Hospital, University of São Paulo Medical School
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Group Cognitive Behavior Therapy
Selective Serotonin Reuptake Inhibitor
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Quality of life measured by SF 36 and social adjustment measured by EAS.
Full Information
NCT ID
NCT00680602
First Posted
May 15, 2008
Last Updated
February 13, 2009
Sponsor
University of Sao Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
1. Study Identification
Unique Protocol Identification Number
NCT00680602
Brief Title
Group Cognitive Behavioral Therapy Versus Fluoxetine for Obsessive-Compulsive Disorder: a Practical Trial
Acronym
GCBTVF
Official Title
Group Cognitive Behavioral Therapy Versus Fluoxetine for Obsessive-Compulsive Disorder: a Randomized Open Trial for Any Patient.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2009
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Sao Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive Compulsive Disorder
Keywords
behavior therapy, group therapy, psychopharmacology
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
158 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Group Cognitive Behavior Therapy
Arm Title
2
Arm Type
Active Comparator
Arm Description
Selective Serotonin Reuptake Inhibitor
Intervention Type
Behavioral
Intervention Name(s)
Group Cognitive Behavior Therapy
Other Intervention Name(s)
behavior therapy, CBT, group psychotherapy
Intervention Description
Structured protocol described by Cordioli et al., 2003
Intervention Type
Drug
Intervention Name(s)
SSRI (fluoxetine, sertraline, paroxetine, citalopram)
Other Intervention Name(s)
Prozac, Zoloft, Paxil, Cipramil
Intervention Description
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)
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Quality of life measured by SF 36 and social adjustment measured by EAS.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cristina B Silva, Psychologist
Organizational Affiliation
University of São Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Psychiatry, Clinics Hospital, University of São Paulo Medical School
City
São Paulo
State/Province
SP
ZIP/Postal Code
05403-010
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
23948637
Citation
da Conceicao Costa DL, Shavitt RG, Castro Cesar RC, Joaquim MA, Borcato S, Valerio C, Miguel EC, Diniz JB. Can early improvement be an indicator of treatment response in obsessive-compulsive disorder? Implications for early-treatment decision-making. J Psychiatr Res. 2013 Nov;47(11):1700-7. doi: 10.1016/j.jpsychires.2013.07.006. Epub 2013 Aug 13.
Results Reference
derived
PubMed Identifier
22841131
Citation
Hoexter MQ, Dougherty DD, Shavitt RG, D'Alcante CC, Duran FL, Lopes AC, Diniz JB, Batistuzzo MC, Evans KC, Bressan RA, Busatto GF, Miguel EC. Differential prefrontal gray matter correlates of treatment response to fluoxetine or cognitive-behavioral therapy in obsessive-compulsive disorder. Eur Neuropsychopharmacol. 2013 Jul;23(7):569-80. doi: 10.1016/j.euroneuro.2012.06.014. Epub 2012 Jul 27.
Results Reference
derived
PubMed Identifier
21907540
Citation
Belotto-Silva C, Diniz JB, Malavazzi DM, Valerio C, Fossaluza V, Borcato S, Seixas AA, Morelli D, Miguel EC, Shavitt RG. Group cognitive-behavioral therapy versus selective serotonin reuptake inhibitors for obsessive-compulsive disorder: a practical clinical trial. J Anxiety Disord. 2012 Jan;26(1):25-31. doi: 10.1016/j.janxdis.2011.08.008. Epub 2011 Aug 19.
Results Reference
derived
PubMed Identifier
19578654
Citation
Fossaluza V, Diniz JB, Pereira Bde B, Miguel EC, Pereira CA. Sequential allocation to balance prognostic factors in a psychiatric clinical trial. Clinics (Sao Paulo). 2009;64(6):511-8. doi: 10.1590/s1807-59322009000600005.
Results Reference
derived
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Group Cognitive Behavioral Therapy Versus Fluoxetine for Obsessive-Compulsive Disorder: a Practical Trial
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