This trial is active, not recruiting.

Condition schizophrenia
Treatment psychosocial treatment/psychodynamic treatment
Sponsor University of Copenhagen
Collaborator University of Aarhus
Start date October 1997
End date July 2005
Trial identifier NCT00221585, 5490-184


A prospective, longitudinal, multi-centre investigation (16 centres), including 562 patients, consecutively referred during two years, with a first-episode psychosis of ICD-10, F-2 type. Patients were treated with: 1) ‘Supportive psychodynamic psychotherapy as a supplement to treatment as usual’, 2) an ‘Integrated, assertive, psychosocial and educational treatment programme’, and 3) ‘Treatment as usual’.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model defined population
Primary purpose screening
Time perspective longitudinal

Eligibility Criteria

Male or female participants from 16 years up to 35 years old.

Inclusion Criteria: consecutively referred patients, age 16-35 years, who suffered from a first-episode psychosis of the schizophrenic spectrum disorder (ICD-10, DF 20-29). - Exclusion Criteria: - patients suffering from mental retardation or other organic brain damage, and patients who were not proficient enough in Danish due to their foreign origins.

Additional Information

Description The study is a prospective, comparative, longitudinal study with an intervention period of a minimum of two years and a registration of data at baseline and 1, 2 and 5 years after inclusion. Three sub-cohorts with different treatment modalities were designed: Treatment1: 119 patients were, in addition to TaU, offered SPP, i.e. a scheduled manualised supportive individual psychotherapy (1 session of 45 min. per week, for a period of 1-3 years) and/or group psychotherapy (1 session of 60 min. per week for a period of 1-3 years). Anti-psychotic medication was given in doses based on individual needs; Treatment 2: 139 patients were offered IT, i.e. a scheduled, two-year long programme consisting of assertive community treatment, psycho-educational multi-family treatment (a.m. McFarlane, consisting of 4-6 families including the patients, meeting 1½ hour every second week for 1½ year), social skills training (concerning medication, self-management, coping with symptoms, conversational skills, problem and conflict solving skills), and antipsychotic medication (low dose strategy). This project, OPUS, has been described in detail elsewhere
Trial information was received from ClinicalTrials.gov and was last updated in November 2006.
Information provided to ClinicalTrials.gov by University of Copenhagen.