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

NCT ID: NCT02850445

Last Updated: 2016-08-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 170 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31

Brief Summary

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.

Conditions

Schizophrenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Integrated Treatment

Group Type: EXPERIMENTAL

Olanzapine

Intervention Type: DRUG

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.

Cognitive behavior therapy

Intervention Type: OTHER

Patients with schizophrenia allocated to the Integrated Treatment(IT) group received Cognitive behavioral therapy.

Rehabilitation treatment

Intervention Type: OTHER

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.

Case management

Intervention Type: OTHER

Patients with schizophrenia allocated to the Integrated Treatment(IT) group received Case management.

antipsychotic medication alone treatment

Group Type: ACTIVE_COMPARATOR

Olanzapine

Intervention Type: DRUG

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.

Interventions

Olanzapine

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.

Intervention Type: DRUG

Cognitive behavior therapy

Patients with schizophrenia allocated to the Integrated Treatment(IT) group received Cognitive behavioral therapy.

Intervention Type: OTHER

Rehabilitation treatment

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.

Intervention Type: OTHER

Case management

Patients with schizophrenia allocated to the Integrated Treatment(IT) group received Case management.

Intervention Type: OTHER

Eligibility Criteria

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.
• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guangzhou Psychiatric Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Shenglin She

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Guangzhou psychitric hosptial

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yingjun Zheng, MD,PhD

Role: CONTACT

brainzheng@163.com

+8618998303126

Facility Contacts

Yingjun Zheng, Phd,Md

Role: primary

brainzheng@163.com

+8618998303126

References

She S, Deng Y, Chen Y, Wu C, Yi W, Lu X, Chen X, Li J, Li R, Zhang J, Xiao D, Wu H, Ning Y, Zheng Y. Two-stage integrated care versus antipsychotic medication alone on outcomes of schizophrenia: One-year randomized controlled trial and follow-up. Psychiatry Res. 2017 Aug;254:164-172. doi: 10.1016/j.psychres.2017.04.054. Epub 2017 Apr 25.

Reference Type: DERIVED

PMID: 28463714 (View on PubMed)

Other Identifiers

Huiai 2014Y2-00105

Identifier Type: -

Identifier Source: org_study_id