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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Randomised Clinical Trial of Integrated Treatment Versus Standard Treatment in First Episode Psychosis

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

Intervention / Treatment
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* Behavioral: Integrated treatment, family involvement
* Behavioral: Social skills training


Participation Criteria
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Eligibility Criteria
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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:

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Integrated treatment, family involvement|nan|
|Behavioral: Social skills training|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psychotic symptoms at one and two year follow-up |  |  | 
| Negative symptoms at one and two year follow-up |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Schizophrenia, First episode psychosis, Psychosocial intervention