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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by Bispebjerg Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Ministry of the Interior and Health, Denmark
Ministry of Social Affairs, Denmark
University of Copenhagen
Copenhagen Hospital Corporation
Medical Research Council
Wørzners Foundation.
Information provided by:
Bispebjerg Hospital
ClinicalTrials.gov Identifier:
NCT00157313
First received: September 8, 2005
Last updated: April 25, 2006
Last verified: September 2005
  Purpose

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.


Condition Intervention
Psychotic Disorders
Schizophreniform Disorders
Schizoaffective Disorder
Psychosis, Brief Reactive
Schizophrenia, Borderline
Behavioral: Integrated treatment, family involvement
Behavioral: Social skills training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomised Clinical Trial of Integrated Treatment Versus Standard Treatment in First Episode Psychosis

Resource links provided by NLM:


Further study details as provided by Bispebjerg Hospital:

Primary Outcome Measures:
  • Psychotic symptoms at one and two year follow-up
  • Negative symptoms at one and two year follow-up

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 600
Study Start Date: January 1998
Estimated Study Completion Date: December 2005
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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00157313

Locations
Denmark
Bispebjerg Hospital, department of psychiatry
Copenhagen, Denmark, 2400
Sponsors and Collaborators
Bispebjerg Hospital
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
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00157313     History of Changes
Other Study ID Numbers: OPUS trial
Study First Received: September 8, 2005
Last Updated: April 25, 2006
Health Authority: Denmark: National Board of Health

Keywords provided by Bispebjerg Hospital:
Schizophrenia
First episode psychosis
Psychosocial intervention

Additional relevant MeSH terms:
Schizophrenia
Disease
Psychotic Disorders
Mental Disorders
Schizotypal Personality Disorder
Schizophrenia and Disorders with Psychotic Features
Pathologic Processes
Personality Disorders

ClinicalTrials.gov processed this record on October 01, 2014