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

B

Bispebjerg Hospital

Status

Unknown

Conditions

Schizophrenia, Borderline
Psychosis, Brief Reactive
Schizophreniform Disorders
Psychotic Disorders
Schizoaffective Disorder

Treatments

Behavioral: Social skills training
Behavioral: Integrated treatment, family involvement

Study type

Interventional

Funder types

Other

Identifiers

NCT00157313
OPUS trial

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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:

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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