Cognitive Therapy and Cognitive Training in Work Rehabilitation for Persons With Severe Mental Illness. A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- The Work Behavior Inventory
研究概览
简要总结
This study will compare the effects of cognitive behaviour therapy (CBT) and cognitive training in work rehabilitation of patients with severe mental illness (psychoses).
These interventions will be compared with a matched control group ('treatment as usual'). The patients will be recruited in nine different counties in Norway. During a two-year period around 27-30 patients can be recruited from each county, meaning that each intervention arm will contain approximately 80 patients. The evaluation of the patients will include several validated diagnostic instruments as described below. The counties has been randomised to the two different intervention groups by a neutral institution: 1.group receiving work rehabilitation based on cognitive behaviour therapy, and 2.group receiving cognitive training. The control group will be matched according to gender and age. With Ntotal=160 for the comparison of two groups (80 patients x 2), a 0.05 level of significance and a power of 0.80, a standardised group difference of 0.44 can be detected. The standardised difference detected between supported employment and treatment as usual has been as high as 0.80 in comparable American studies, indicating that N is large enough in the present study.
The participants in each county will be evaluated and followed by a local project coordinator and by a local psychiatrist/psychologist in a District Psychiatric Centre. Written evaluation protocols will be sent anonymously to the research centre for registration. Data will be stored according to current laws of person protection and data security. Pre-post differences in each group, differences between the control group and the intervention groups, and differences between the intervention groups will be tested using a mixed linear model programme.
Research questions The project will compare the effects of CBT oriented work rehabilitation and work rehabilitation with cognitive training with regard to the ability of persons with severe mental disorders to cope with and keep a job. The two intervention arms will be compared with each other and with a matched treatment as usual control group.
Main hypotheses
- By the end of the project (T2) and by follow up examination (T3) the global psychosocial function of patients will be higher in the CBT work rehabilitation group than in the control group
- The global psychosocial function of patients at T2 and T3 will be higher in the cognitive training group than in the control group
详细描述
Cognitive behaviour therapy and cognitive training in work rehabilitation for persons with severe mental illness.
A randomised controlled trial
Introduction This study will compare the effects of cognitive behaviour therapy (CBT) and cognitive training in work rehabilitation of patients with severe mental illness (psychoses).
These interventions will be compared with a matched control group ('treatment as usual'). The patients will be recruited in nine different counties in Norway. During a two-year period around 27-30 patients can be recruited from each county, meaning that each intervention arm will contain approximately 80 patients. The evaluation of the patients will include several validated diagnostic instruments as described in the detailed description below. The counties will be randomised to the two different intervention groups: 1. a group receiving CBT inspired work rehabilitation, and 2. a group receiving work rehabilitation integrated with cognitive training. The control group will be matched according to gender and age. With Ntotal=160 for the comparison of two groups (80 patients x 2), a 0.05 level of significance and a power of 0.80, a standardised group difference of 0.44 can be detected. The standardised difference detected between supported employment and treatment as usual has been as high as 0.80 in comparable American studies, indicating that N is large enough in the present study.
The participants in each county will be evaluated and followed by a local project coordinator in a District Psychiatric Centre (DPS), and by a local psychiatrist/psychologist. Written evaluation protocols will be sent anonymously to the research centre for registration. Data will be stored according to current laws of person protection and data security. Pre-post differences in each group, differences between the control group and the intervention groups, and differences between the intervention groups will be tested using a mixed linear model programme.
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Persons with schizophrenia spectrum disorders
排除标准
- •neurological disease diagnosis
- •Active suicidality
- •Severe drug abuse
结局指标
主要结局
The Work Behavior Inventory
时间窗: Ten months
The instrument assesses various dimensions of the participant's work performance
次要结局
- The Positive and Negative Symptom Scale (PANSS)(Ten months)
- The Drug Use Disorder Identification Test(Ten months)
- The Global Assessment of Function(Ten months)
- The Apathy Evaluation Scale(Ten months)
- The Alcohol Use Disorder Identification Test(Ten months)
- The Measurement and Treatment Research to Improve Cognitive Function in Schizophrenia(Ten months)