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

13. februar 2009 opdateret af: University of Sao Paulo

Group Cognitive Behavioral Therapy Versus Fluoxetine for Obsessive-Compulsive Disorder: a Randomized Open Trial for Any Patient.

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

158

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Brasilien
    • SP
      • São Paulo, SP, Brasilien, 05403-010
        • Institute of Psychiatry, Clinics Hospital, University of São Paulo Medical School

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Sundhedstjenesteforskning
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 1
Group Cognitive Behavior Therapy
Adfærdsmæssigt: Group Cognitive Behavior Therapy
Structured protocol described by Cordioli et al., 2003
Andre navne:
  • CBT
  • adfærdsterapi
  • group psychotherapy
Aktiv komparator: 2
Selective Serotonin Reuptake Inhibitor
Medicin: 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)
Andre navne:
  • Zoloft
  • Prozac
  • Paxil
  • Cipramil

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
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.
Tidsramme: 12 weeks
12 weeks

Sekundære resultatmål

Resultatmål
Tidsramme
Quality of life measured by SF 36 and social adjustment measured by EAS.
Tidsramme: 12 weeks
12 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Sao Paulo

Samarbejdspartnere

Fundação de Amparo à Pesquisa do Estado de São Paulo

Efterforskere

  • Ledende efterforsker: Cristina B Silva, Psychologist, University of Sao Paulo

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. januar 2006

Primær færdiggørelse (Faktiske)

1. september 2008

Studieafslutning (Faktiske)

1. september 2008

Datoer for studieregistrering

Først indsendt

15. maj 2008

Først indsendt, der opfyldte QC-kriterier

19. maj 2008

Først opslået (Skøn)

20. maj 2008

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

16. februar 2009

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

13. februar 2009

Sidst verificeret

1. februar 2009

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 06/50829-8

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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