Individual Placement and Support (IPS) Enhanced With Cognitive Remediation and Social Skills Training in Denmark: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 717
- 试验地点
- 2
- 主要终点
- Hours in competitive employment or education
研究概览
简要总结
The purpose of this study is to investigate the efficacy of IPS in Denmark and compare effects of 1. Individual Placement and Support (IPS) vs. 2. IPS + cognitive remediation and work-related social skills training vs. 3. standard intervention, among individuals with severe mental illness.
详细描述
Individual Placement and Support (IPS) is established as the most effective vocational intervention available for persons with severe mental illness,and the intervention is widely recognized as an evidence-based practice. Despite evidence, long-term job retention and economic self-sufficiency have not been clearly demonstrated. Research has suggested that integrating methods such as cognitive remediation and social skills training could reduce such limitations. Further, there has not been conducted any randomized controled trials with IPS in Scandinavian countries with highly developed and generous social security and welfare systems, and with high thresholds to the open labour market.
The aim of this study is to investigate the effectiveness of IPS in Denmark and compare effects of 1. IPS vs. 2. IPS + cognitive remediation and work-related social skills training vs. 3. Standard intervention.
The intervention is based on the 7 principles of IPS Supported Employment, and IPS enhanced with cognitive remediation and work-related social skills training, consists of 24 sessions of computer based cognitive training and 24 group based sessions of cognitive coping strategies and work-related social skills training.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Psychosis within the schizophrenic spectrum (F 2, International Classification of Diseases (ICD 10)).
- •Severe depression (F33, ICD-10) or Bipolar disorder (F31, ICD-10) and minimum 3 years psychiatric treatment.
- •Motivated for employment or education. 18 to 65 years old. Participants must speak and understand Danish.
排除标准
- •Lack of informed consent Above 64 years and receiving state pension Match group 1 (No problems besides unemployment)
研究组 & 干预措施
Standard intervention
Individual Placement and Support (IPS)
干预措施: Individual Placement and support (IPS) (Behavioral)
IPS plus
Individual Placement and Support plus cognitive remediation and work-related social skills training
干预措施: Individual Placement and support (IPS) (Behavioral)
IPS plus
Individual Placement and Support plus cognitive remediation and work-related social skills training
干预措施: IPS plus (Behavioral)
结局指标
主要结局
Hours in competitive employment or education
时间窗: Measured at 18 month
次要结局
- Negative symptoms measured with Schedule for assessment of negative symptoms in schizophrenia (SANS)(Measured at 18 month follow-up)
- In competitive employment or education at some point during follow up period(Measured at 18 month follow-up)
- Days to first employment or beginning of education(Measured at 18 month follow-up)
- Average monthly earnings in follow-up period(Measured at 18 month follow-up)
- Cognitive functions measured with The Brief Assessment of Cognition in Schizophrenia (BAC)(Measured at 18 month follow-up)
- Hours of work per week among those who obtain competitive employment during the follow-up period(Measured at 18 month follow-up)
- Functioning measured with Global Assessment of Functioning (GAF)(Measured at 18 month follow-up)
- Self-esteem measured with The Rosenberg Self-Esteem scale(Measured at 18 month follow-up)
- Functioning measured with Personal and Social Performance (PSP)(Measured at 18 month follow-up)
- Quality of life measured with SF-12(Measured at 18 month follow-up)
- Empowerment measured with Empowerment Scale(Measured at 18 month follow-up)
- Self-efficacy measured with General self-efficacy scale (GSE)(Measured at 18 month follow-up)