Effectiveness and Cost Effectiveness of Individual Career Management for People With Anxiety and Depression: A Randomised Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 261
- 试验地点
- 2
- 主要终点
- Length of Competitive Employment
研究概览
简要总结
The aim of the investigation is to evaluate the effectiveness and costeffectiveness of a model of supported employment (the Individual Career Management (ICM) model) designed to help people with common mental illness return to work.
详细描述
The design of the study is a randomised controlled trial of two groups in a natural setting (intervention group vs control group). The primary outcome is paid employment. Standard care for all participants is a package of psychological therapy (IAPT). The intervention is an additional package of employment support (ICM) delivered alongside standard care.
The intervention group and control group will both receive standard care. The intervention group will receive ICM support in addition to standard care and the control group will be given details of other employment programmes in the local area, in line with current IAPT practice. The control period will last six months. There will be no fewer than 184 participants in the study (92 in each arm).
The study will take place at the Southwark Psychological Therapies Service at the SLaM NHS Foundation Trust. Patients that meet the inclusion criteria will be invited to attend an interview where written informed consent and baseline measures will be obtained. The participant will then be randomly assigned to either the intervention or control group. All participants will be invited to attend a second interview at the end of a six month period where followup measures will be taken. If the intervention is available at this time, control group participants may then be offered the opportunity to receive it.
A randomised controlled trial of supported employment for people with common mental health problems has never been carried out in the UK, therefore this study will be the first of its kind. The results will help to determine if ICM is an effective and costeffective service and will provide the foundations for further research in this area.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Investigator)
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
- 是
入选标准
- •Must be either unemployed or off sick for at least two weeks if employed at the time of entry to the study
- •Must be legally allowed to work in the UK
- •Must be between the age of 18-65 for men, and 18-60 for women (based on UK retirement age)
- •Must have received an IAPT assessment and been offered psychological therapy
- •Must not have been receiving therapy for more than one month
- •Must be interested in obtaining competitive employment
- •Must have given full written consent to participate in the study
- •Exclusion criteria:
- •People who are employed and attending work or off sick for less than two weeks at the time of entry to the study
- •People who do not have the legal right to work in the UK
- •People who have not yet received an IAPT assessment
- •People who have received an IAPT assessment but not eligible for psychological therapy
- •People who have been receiving therapy for more than one month
- •People who are not interested in obtaining competitive employment
- •People who do not give written consent or who lack mental capacity to give consent at the time of the study
排除标准
- 未提供
结局指标
主要结局
Length of Competitive Employment
时间窗: 6 months
Length of competitive employment during the 6 month study period. The following definition of competitive employment will be used: 1. A job paying at least the national minimum wage. 2. A job located in a mainstream setting not set aside for people with disabilities. 3. A job that is not owned by the ICM service.
次要结局
- Return to Work Efficacy(6 months)
- Working Hours(6 months)
- Career Search Efficacy(6 months)
- Health-related quality of Life(6 months)
- Work-related quality of Life(6 months)
- Self Esteem(6 months)
- Time to Employment(6 months)
- Number of Jobs(6 months)
- Anxiety(6 months)
- Depression(6 months)
- Salary(6 months)
- Job Terminations(6 months)
- Other occupational activity(6 months)
- Social Functioning(6 months)
- Productivity(6 months)
研究者
Claire Price
Employment & Social Inclusion Manager
South London and Maudsley NHS Foundation Trust