Group Cognitive Behavioral Therapy Versus Fluoxetine for Obsessive-Compulsive Disorder: a Practical Trial
Condition: Obsessive Compulsive Disorder
MeSH terms: Compulsive Personality Disorder; Obsessive-Compulsive Disorder
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): Group Cognitive Behavior Therapy; SSRI (fluoxetine, sertraline, paroxetine, citalopram)
Intervention type(s): Behavioral; Drug
Intervention description(s): Structured protocol described by Cordioli et al., 2003; 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 intervention name(s): behavior therapy; CBT; group psychotherapy; Prozac; Zoloft; Paxil; Cipramil
Intervention MeSH terms: Sertraline; Fluoxetine; Paroxetine; Citalopram
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: behavior therapy; group therapy; psychopharmacology