Trial and Follow-up of the Efficacy of Two-stage Integrated Treatment for Chinese Schizophrenia Inpatients

Study Overview
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Brief Summary
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Regular psychosocial intervention combined with antipsychotic drugs, compared with usual medication alone treatments, can reduce psychiatric symptoms and improve quality of life in patients with schizophrenia. However, it's expensive, time-consuming, and sometimes inconvenient for patients and their family members in developing areas where the number of well-trained therapist remains limited in local psychiatric settings. The investigators aimed to establish an efficient model of integrated treatment (IT) for patients with schizophrenia. The procedure contains two stages: a centralized treatment during hospitalization and the following consolidation treatments with long intervals.

Official Title
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Effects of Integrated Treatment for Chinese Patients With Schizophrenia: 1-year Follow-up

Conditions
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Schizophrenia

Intervention / Treatment
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* Drug: Olanzapine
* Other: Cognitive behavior therapy
* Other: Rehabilitation treatment
* Other: Case management


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with the Structured Clinical Interview for DSM-IV (SCID-DSM-IV) (First et al., 1996), were recruited from inpatient psychiatric ward. Patients with diagnoses of schizoaffective or other psychotic disorders were not included. Additional inclusion criteria for participants were aged between 18 and 50 years with education of more than 9 years, and PANSS (Positive and Negative Syndrome Scale) total scores of more than 60. Exclusion Criteria: Diagnosed with a serious and unstable medical condition including abuse and/or dependence of alcohol and/or drugs; Pregnant or breastfeeding; Under a treatment of clozapine with a dose of more than 200 mg/day, Had a treatment of the electroconvulsive therapy (ECT) or modified electroconvulsive therapy within 6 months(MECT) within the past six months.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Integrated Treatment<br> | Drug: Olanzapine<br>* All patients with schizophrenia were under medication treatment at the baseline. Individualized plan of antipsychotic medication for the patients were determined by psychiatrist who were blind to the group allocation. Medications could be changed at any time during the course of the study if the change was clinically warranted, the drug can also be any other antipsychotic medication.<br>Other: Cognitive behavior therapy<br>* Patients with schizophrenia allocated to the Integrated Treatment(IT) group received Cognitive behavioral therapy.<br>Other: Rehabilitation treatment<br>* Rehabilitation treatment include three modules: medication management, symptom management, and social kill training. Patients with schizophrenia allocated to the Integrated Treatment(IT) group received Rehabilitation treatment therapy.<br>Other: Case management<br>* Patients with schizophrenia allocated to the Integrated Treatment(IT) group received Case management.<br>|
| Active Comparator: antipsychotic medication alone treatment<br> | Drug: Olanzapine<br>* All patients with schizophrenia were under medication treatment at the baseline. Individualized plan of antipsychotic medication for the patients were determined by psychiatrist who were blind to the group allocation. Medications could be changed at any time during the course of the study if the change was clinically warranted, the drug can also be any other antipsychotic medication.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medication nonadherence was assessed in two groups after 12-month follow-up. | Medication non-adherence was defined as a failure to take medication for one week or longer | One year follow-up | 
| Rehospitalization rate was assessed in two groups after 12-month follow-up. |  | One year follow-up | 
| Rate of Relapse was assessed in two groups after 12-month follow-up. |  | One year follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of symptoms in each group was assessed by the change of PANSS(Positive and Negative Syndrome Scale) total scale score. | Time course and treatment differences for changes in the PANSS( Positive and Negative Syndrome Scale) was analyzed using Mixed-Effects Model for Repeated-Measures analyses (MMRM). | One year follow-up | 
| Improvement of symptoms in each group was assessed by the change of CGI( Clinical Global Impressions) scale score. | Time course and treatment differences for changes in the CGI( Clinical Global Impressions) was analyzed using Mixed-Effects Model for Repeated-Measures analyses (MMRM). | One year follow-up | 
| Social functioning in each group was assessed by the change of PSP(Personal and Social Performance)scale score. | Time course and treatment differences for changes in the PSP(Personal and Social Performance) were analyzed using Mixed-Effects Model for Repeated-Measures analyses (MMRM). | One year follow-up |