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The National Danish Schizophrenia Project

Sponsor
University of Copenhagen (Other)
Overall Status
Unknown status
CT.gov ID
NCT00221585
Collaborator
University of Aarhus (Other)
1
Location
93
Duration (Months)

Study Details

Study Description

Brief Summary

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'.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Psychosocial treatment/Psychodynamic treatment

Detailed 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

Study Design

Study Type:
Observational
Observational Model:
Defined Population
Time Perspective:
Prospective
Study Start Date :
Oct 1, 1997
Study Completion Date :
Jul 1, 2005

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    16 Years to 35 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Psychiatric Hospitäl in Aarhus Risskov Aarhus Denmark 8240

    Sponsors and Collaborators

    • University of Copenhagen
    • University of Aarhus

    Investigators

    • Study Director: Bent Rosenbaum, DMSci, Psychiatric Center Glostrup, Dernmark

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00221585
    Other Study ID Numbers:
    • 5490-184
    First Posted:
    Sep 22, 2005
    Last Update Posted:
    Nov 7, 2006
    Last Verified:
    Jul 1, 1997
    Additional relevant MeSH terms:
    Schizophrenia

    Study Results

    No Results Posted as of Nov 7, 2006