Extended Specialized Assertive Intervention for First Episode Psychosis
Condition: First Episode Psychosis of Schizophrenia and Schizotypal Disorder; Psychotic Disorders; Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders; Mental Disorders
Study type: Interventional

Summary: 
      In a randomized clinical trial, the researchers want to investigate if the positive
      short-term outcomes (first 1-2 years), achieved with specialized assertive intervention
      programme (OPUS), can be maintained for five years if the specialized treatment is sustained
      over the first five years in comparison to only two years of specialized treatment followed
      by three years of standard treatment.
    

Detailed description: 
      The Danish OPUS I trial succeeded in randomizing 547 patients with first-episode psychosis to
      a two-year specialized intensive treatment program (OPUS) or standard treatment. The results
      clearly favored OPUS treatment, and psychotic and negative symptoms, substance abuse,
      adherence to treatment, use of anti-psychotic medication, user satisfaction, and use of bed
      days were better in OPUS compared to standard treatment. However, the five-year follow-up,
      three years after patients from OPUS were transferred to standard treatment, showed that the
      positive clinical effects were not sustained, when the intensive treatment was terminated,
      except from OPUS-patients being less likely to stay in institutions than patients who
      received standard care.

      Objective: The aim in OPUS II trial is to compare the effect of five-years versus two-years
      specialized assertive intervention program (OPUS-treatment) for first episode psychosis on
      clinical symptoms, substance abuse, institutionalization, and labor market affiliation.

      Hypothesis: It is possible to maintain the positive results of the intensive two-year
      intervention in another three years for those who keep receiving the specialized assertive
      intervention program.

      Design: Open label randomized clinical trial. Setting: Psychiatric Center Bispebjerg and
      Center for Psychiatric Research Aarhus, Denmark.Participants: 400 patients with first episode
      of schizophrenia spectrum disorder received treatment in one of the six OPUS - teams for 1½
      years.

      Intervention: Another 3½ years OPUS-treatment versus ½ year OPUS-treatment and thereafter
      referral to standard treatment. The extended OPUS treatment consist modified assertive case
      management, rational pharmacotherapy, family psycho-educational intervention, group
      interventions to aid with recovery, social skills training, cognitive behavior therapy when
      indicated, and crisis intervention. OPUS-treatment is tailored to meet the individual
      patient's needs.
    

Intervention name(s): 2 years OPUS treatment; OPUS 5 years
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 2 years OPUS and transfer to standard treatment.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Randomized clinical trial; first episode psychosis of schizophrenia and schizotypal disorder; rehabilitation; psychosocial; health service research; schizotypal Disorder