Effects of Integrated Treatment for Chinese Patients With Schizophrenia: 1-year Follow-up
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 170
- 试验地点
- 1
- 主要终点
- Rate of Relapse was assessed in two groups after 12-month follow-up.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Integrated Treatment
干预措施: Olanzapine (Drug)
Integrated Treatment
干预措施: Cognitive behavior therapy (Other)
Integrated Treatment
干预措施: Rehabilitation treatment (Other)
Integrated Treatment
干预措施: Case management (Other)
antipsychotic medication alone treatment
干预措施: Olanzapine (Drug)
结局指标
主要结局
Rate of Relapse was assessed in two groups after 12-month follow-up.
时间窗: One year follow-up
Medication nonadherence was assessed in two groups after 12-month follow-up.
时间窗: One year follow-up
Medication non-adherence was defined as a failure to take medication for one week or longer
Rehospitalization rate was assessed in two groups after 12-month follow-up.
时间窗: One year follow-up
次要结局
- 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)
研究者
Shenglin She
Clinical Professor
Guangzhou Psychiatric Hospital