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Clinical Trial of Integrated Treatment Versus Standard Treatment in First Episode Psychosis

This study is ongoing, but not recruiting participants.
Study NCT00157313.   Last updated on April 25, 2006.   Information provided by Bispebjerg Hospital

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Descriptive Information Fields
Brief Title  Clinical Trial of Integrated Treatment Versus Standard Treatment in First Episode Psychosis
Official Title  Randomised Clinical Trial of Integrated Treatment Versus Standard Treatment in First Episode Psychosis
Brief Summary

The purpose of the study was to evaluate the effects of integrated treatment for patients with a first episode of psychotic illness. We conducted a randomised clinical trial in Copenhagen Hospital Corporation and Psychiatric Hospital Aarhus, Denmark. We included 547 patients with first episode of schizophrenia spectrum disorder, who has not received antipsychotic medication for more than 12 weeks.

Patients were randomised to integrated treatment or standard treatment. The integrated treatment lasted for two years and consisted of assertive community treatment with programmes for family involvement and social skills training. Standard treatment offered contact with a community mental health centre.

We wanted to study the effect on psychotic (hallucinations and delusions)and negative (lack of initiative, apati, blunted affect) symptoms (each scored from 0 to a maximum of 5) at one and two years’ follow-up.

We found that integrated treatment improved clinical outcome and adherence to treatment. The improvement in clinical outcome was consistent at one year and two year follow-ups. We will study further outcome measures such as social network, quality of life, depression and suicidal behaviour.

Detailed Description

Objectives: To evaluate the effects of integrated treatment for patients with a first episode of psychotic illness.

Design: Randomised clinical trial. Setting: Copenhagen Hospital Corporation and Psychiatric Hospital Aarhus, Denmark Participants: 547 patients with first episode of schizophrenia spectrum disorder.

Interventions: Integrated treatment and standard treatment. The integrated treatment lasted for two years and consisted of assertive community treatment with programmes for family involvement and social skills training. Standard treatment offered contact with a community mental health centre.

Main outcome measures: Psychotic and negative symptoms (each scored from 0 to a maximum of 5) at one and two years’ follow-up.

Results: At one year’s follow-up, psychotic symptoms changed favourably to a mean of 1.09 (standard deviation 1.27) with an estimated mean difference between groups of –0.31 (95% confidence interval –0.55 to –0.07, P=0.02) in favour of integrated treatment. Negative symptoms changed favourably with a estimated difference between groups of –0.36 (–0.54 to –0.17, P<0.001) in favour of integrated treatment. At two years’ follow-up the estimated mean difference between groups in psychotic symptoms was –0.32 (0.58 to –0.06, P=0.02) and in negative symptoms was –0.45 (–0.67 to –0.22, P<0.001), both in favour of integrated treatment. Patients who received integrated treatment had significantly less comorbid substance misuse, better adherence to treatment, and more satisfaction with treatment.

Conclusion: Integrated treatment improved clinical outcome and adherence to treatment. The improvement in clinical outcome was consistent at one year and two year follow-ups.

Study Phase
Study Type  Interventional
Study Design  Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Primary Outcome Measure  Psychotic symptoms at one and two year follow-up
Negative symptoms at one and two year follow-up
Secondary Outcome Measure  Adherence at one and two year follow-up
Depression at one and two year follow-up
Suicidal behaviour at one and two year follow-up
Use satisfaction at one and two year follow-up
Quality of life at one and two year follow-up
Condition  Psychotic Disorders
Schizophreniform Disorders
Schizoaffective Disorder
Psychosis, Brief Reactive
Schizophrenia, Borderline
Intervention  Behavioral: Integrated treatment, family involvement
Behavioral: Social skills training
MEDLINE PMIDs 12271808,   16141449,   16122909,   16055817,   16055815,   15863743,   11016522
Links
Recruitment Information Fields
Recruitment Status  Active, not recruiting
Enrollment  600
Start Date  January 1998
Completion Date December 2005
Eligibility Criteria 

Inclusion Criteria:

  • 18-45 years of age
  • F2 diagnosis in ICD 10
  • Address in Copenhagen, Frederiksberg or Aarhus
  • Antipsychotic medication not exceeding 12 weeks
  • Informed consent

Exclusion Criteria:

Gender Both
Ages 18 Years to 45 Years
Accepts Healthy Volunteers No
Contacts ††
Location Countries  Denmark
Administrative Information Fields
NCT ID  NCT00157313
Organization ID OPUS trial
Secondary IDs ††
Study Sponsor  Bispebjerg Hospital
Collaborators †† Ministry of the Interior and Health, Denmark
Ministry of Social Affairs, Denmark
University of Copenhagen
Copenhagen Hospital Corporation
Medical Research Council
Wørzners Foundation.
Investigators 
Principal Investigator:     Merete Nordentoft, Ph.D.     Bispebjerg Hospital, department of psychiatry, University of Copenhagen    
Information Provided By Bispebjerg Hospital
Verification Date September 2005
First Received Date  September 8, 2005
Last Updated Date April 25, 2006

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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