Tailored Treatment of Insomnia in Social and Health Care Sector Shift Workers in Occupational Health Care
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 84
- 试验地点
- 5
- 主要终点
- Change from baseline in mean of Insomnia Severity Index at the end of treatment (12 weeks after the first session) and at 6 months after the end of treatment.
研究概览
简要总结
The goal of this clinical trial is to evaluate the usefulness of cognitive behavioural therapy for insomnia (CBT-I) tailored to shift workers in the social and health care sector. The study will also learn about the shift workers' experiences of the acceptability and feasibility of CBT-I and investigate which features of shift work and individual characteristics promote or interfere with the effectiveness of the tailored CBT-I.
The main question the study aims to answer is:
• Does CBT-I tailored to shift workers in the social and health care sector improve perceived insomnia severity, insomnia symptoms, mental health and quality of life?
Researchers will compare CBT-I to a control intervention (short sleep hygiene counselling) to see if CBT-I works to treat insomnia in shift workers.
Participants will:
- Participate in the research intervention (CBT-I tailored to the shift work context; six individual sessions) or the control intervention (sleep hygiene counselling; one individual session)
- Complete the measures (sleep diary, actigraphy and questionnaires) at baseline, after the end of treatment (12 weeks after the first session) and at 6 months after the end of treatment.
详细描述
Disturbed sleep and insomnia are common among shift workers, and disturbed sleep is considered a key factor in other health risks associated with shift work. However, there are no established treatment practices for treating insomnia in shift workers. This study aims to evaluate the effectiveness of Cognitive-Behavioural Therapy for Insomnia (CBT-I) tailored for social and health care sector shift workers whose work includes night shifts. Furthermore, the study will assess the shift workers' experiences of the acceptability and feasibility of CBT-I from their perspective. The study will also examine which features of shift work and employee characteristics promote or interfere with the effectiveness of the tailored CBT-I.
The study is a randomised controlled trial. Participants will be shift workers in the social and health care sector who work in three or two shifts, including night shifts, and have significant insomnia symptoms. Participants will be recruited through occupational health services (OHS) and social media posts. The FIOH study group will carry out the measurements of the participants. Participants will complete the baseline measures (sleep diary, actigraphy and questionnaires) and then will be randomly assigned to receive the research intervention (CBT-I tailored to the shift work context; six individual sessions) or the control intervention (sleep hygiene counselling; one individual session). The interventions will be delivered by the nurses of the participants´ OHS and the FIOH. Participants will complete the follow-up measures after the end of treatment (12 weeks after the first session) and at 6 months after the end of treatment.
The results of the study can be utilised in OHS to guide and treat shift workers with insomnia as part of supporting their work ability.
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 (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
- 否
入选标准
- •age 18-65 years
- •working in social and heath care sector
- •3- or 2-shift work including night shift at least once per month
- •full time or nearly full time shift work (75-100 %)
- •Insomnia Severity Index score > 10
- •duration of insomnia symptoms at least 3 months
- •shift work continuing for at least the next year
- •sufficient Finnish language skills (coaching materials in Finnish only)
排除标准
- •non-assessed or untreated clinically significant somatic or mental symptoms or illnesses or other sleep disorders that could explain current insomnia symptoms
- •earlier participation to CBT-I
- •other ongoing or planned psychotherapeutic/psychological intervention
研究组 & 干预措施
Cognitive Behavioral Therapy for Insomnia
Cognitive-Behavioural Therapy for Insomnia (CBT-I) is tailored for shift workers in social and health care sector. CBT-I is delivered individually (six sessions) by trained nurses. It includes behavioral methods (sleep compression tailored for shift work context), cognitive methods, and shift work related sleep hygiene counselling.
干预措施: Cognitive behavioral therapy for insomnia (Behavioral)
Sleep hygiene counselling
Sleep hygiene counselling is delivered individually (one session) by trained nurses. It includes sleep hygiene instructions tailored to the context of shift work.
干预措施: Sleep hygiene counselling (Behavioral)
结局指标
主要结局
Change from baseline in mean of Insomnia Severity Index at the end of treatment (12 weeks after the first session) and at 6 months after the end of treatment.
时间窗: From baseline to the end of treatment (12 weeks after the first session) and to the 6 months after the end of treatment.
Insomnia Severity Index (ISI) contains seven items about insomnia during the last month \[item scale 0 (not at all) -4 (very severe)\]. The sum of the scores serves as the ISI score.
次要结局
- Change from baseline in means of insomnia symptoms assessed by sleep diary at the end of treatment (12 weeks after the first session) and at 6 months after the end of treatment.(From baseline to the end of treatment (12 weeks after the first session) and to the 6 months after the end of treatment.)
- Change from baseline in means of insomnia symptoms assessed by actigraphy at the end of treatment (12 weeks after the first session) and at 6 months after the end of treatment.(From baseline to the end of treatment (12 weeks after the first session) and to the 6 months after the end of treatment.)
- Change from baseline in shift work disorder case at the end of treatment (12 weeks after the first session) and at 6 months after the end of treatment.(From baseline to the end of treatment (12 weeks after the first session) and to the 6 months after the end of treatment.)
- Change from baseline in mean insomnia reactivity at the end of treatment (12 weeks after the first session) and at 6 months after the end of treatment.(From baseline to the end of treatment (12 weeks after the first session) and to the 6 months after the end of treatment.)
- Change from baseline in mean of sleep-related dysfunctional cognitions at the end of treatment (12 weeks after the first session) and at 6 months after the end of treatment.(From baseline to the end of treatment (12 weeks after the first session) and to the 6 months after the end of treatment.)
- Change from baseline in mean daytime sleepiness at the end of treatment (12 weeks after the first session) and at 6 months after the end of treatment.(From baseline to the end of treatment (12 weeks after the first session) and to the 6 months after the end of treatment.)
- Change from baseline in mean depression severity at the end of treatment (12 weeks after the first session) and at 6 months after the end of treatment.(From baseline to the end of treatment (12 weeks after the first session) and to the 6 months after the end of treatment.)
- Change from baseline in mean anxiety disorder symptoms at the end of treatment (12 weeks after the first session) and at 6 months after the end of treatment.(From baseline to the end of treatment (12 weeks after the first session) and to the 6 months after the end of treatment.)
- Change from baseline in mean burnout symptoms at the end of treatment (12 weeks after the first session) and at 6 months after the end of treatment.(From baseline to the end of treatment (12 weeks after the first session) and to the 6 months after the end of treatment.)
- Change from baseline in mean quality of life at the end of treatment (12 weeks after the first session) and at 6 months after the end of treatment.(From baseline to the end of treatment (12 weeks after the first session) and to the 6 months after the end of treatment.)
- Change from baseline in mean self-rated work ability at the end of treatment (12 weeks after the first session) and at 6 months after the end of treatment.(From baseline to the end of treatment (12 weeks after the first session) and to the 6 months after the end of treatment.)
- Change from baseline in mean recovery at the end of treatment (12 weeks after the first session) and at 6 months after the end of treatment.(From baseline to the end of treatment (12 weeks after the first session) and to the 6 months after the end of treatment.)