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

NCT02850445 | Unknown

• 1 other identifier: Huiai 2014Y2-00105
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Improvement of symptoms in each group was assessed by the change of PANSS(Positive and Negative Syndrome Scale) total scale score.

  One year follow-up

• Improvement of symptoms in each group was assessed by the change of CGI( Clinical Global Impressions) scale score.

  One year follow-up

• Social functioning in each group was assessed by the change of PSP(Personal and Social Performance)scale score.

  One year follow-up

Study Arms (2)

Integrated Treatment

EXPERIMENTAL

Drug: Olanzapine; Other: Cognitive behavior therapy; Other: Rehabilitation treatment; Other: Case management

antipsychotic medication alone treatment

ACTIVE COMPARATOR

Drug: Olanzapine

Interventions

Olanzapine 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.

Integrated Treatment; antipsychotic medication alone treatment

Cognitive behavior therapy OTHER

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

Integrated Treatment

Rehabilitation treatment 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.

Integrated Treatment

Case management OTHER

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

Integrated Treatment

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guangzhou Psychiatric Hospital: lead

Study Sites (1)

Guangzhou psychitric hosptial

Guangzhou, Guangdong, 510370, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 28463714 DERIVED

MeSH Terms

Conditions

Schizophrenia

Interventions

Olanzapine; Cognitive Behavioral Therapy; Rehabilitation; Case Management

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Patient Care Planning; Comprehensive Health Care; Patient Care Management; Health Services Administration

Central Study Contacts

Yingjun Zheng, MD,PhD

CONTACT

+8618998303126; brainzheng@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: July 14, 2016
• First Posted: August 1, 2016
• Study Start: January 1, 2012
• Primary Completion: December 1, 2016
• Last Updated: August 1, 2016

Record last verified: 2016-07

Locations

CN (1)