Effects of Motivational Interviewing for Long-term Sick Absence: A Randomized Controlled Trial With Mixed Methods
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 774
- 试验地点
- 1
- 主要终点
- Total number of sickness absence days during the year after enrollment in the study (i.e. after randomization)
研究概览
简要总结
Long-term sickness absence has considerable impact on social functioning, families involved, the employer, and society as a whole. Preventing long-term sickness absence and increase the likelihood of return to work (RTW) are critical concerns for industrialized countries across the world. Motivational factors contributing to RTW and maintenance of work participation are therefore of importance to explore in order to get the person back to work after long-term sick leave. Motivational interviewing (MI) is an empirically validated psychological approach that may be particularly useful in a RTW context. Even though MI has been widely studied and is considered a flexible intervention strategy in different domains, its effectiveness in improving RTW has not yet been studied.
The aim of this study is to evaluate whether MI provided by trained caseworkers at The Norwegian Labour and Welfare Administration (NAV) to sick-listed users with unselected diagnoses facilitates RTW compared with follow-up as usual.
详细描述
The main study will be preceded by a pilot study (anticipated start medio august 2017). The aim of the pilot is to test the practical aspects of the study. If no changes are made to the study protocol, the intervention or one of the other arms, participants from the pilot will be included in the main study, In case of modifications to the study protocol after the pilot, participants from the pilot study will not be included in the main study. Data for primary and secondary outcomes will not be assessed before the end of the main study.
In addition to the intention to treat and per protocol analyses, subgroup analyses will be performed if sufficient power for age, gender, diagnoses for sick leave, occupational category and length of previous sick leave.
In addition to the effect evaluation, qualitative studies, a feasibility/process evaluation study and a health economic evaluation (cost-effectiveness, cost-utility and cost-benefit) will be performed. The qualitative studies will be based on data from focus group discussions. The main areas for investigation will be:
- The participants' expectations to return to work before and after motivational interviewing.
- Perceived facilitators and obstacles for return to work among participants
- The perceived benefits and challenges in using motivational interview to facilitate a return to work process
Changes made Sept.29 2017: Due to slow recruitment, it was decided to leave out one of the arms from the study (TAU-1: extra phone call to employer). The extra phone call element was also taken out from the other arms where it was included. Another reason for this change was that the TAU-1 intervention arm was not ideally designed to evaluate the extra phone call. It was decided this intervention arm is better evaluated in a separate trial. Currently 12 persons are included and randomized in the trial. Those who are randomized to TAU-1 and have not received an intervention, will be randomized again. The ones randomized to TAU-1 who already have got an intervention will stop participating in the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Living in the county Sør-Trøndelag
- •On sick leave for 8 weeks
- •Current sick leave status of 50-100%
排除标准
- •no employment
- •pregnancy
结局指标
主要结局
Total number of sickness absence days during the year after enrollment in the study (i.e. after randomization)
时间窗: 12 months
Register data from the national health and welfare services
次要结局
- Return to work expectations(12 months)
- Probability of working (i.e. not receiving medical benefits) each month during follow-up, measured as repeated events(12 months)
- Resilience(12 months)
- Workability(12 months)
- The time until full sustainable return to work (RTW), i.e. for at least 4 weeks without relapse(12 months)
- Return to Work Self-Efficacy(12 months)
- Health-related quality of life(12 months)