Acute Psychological Sleep Stabilisation for Patients Hospitalised With Depression
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Insomnia Severity Index
研究概览
简要总结
Disturbed sleep occurs in almost all patients in psychiatric inpatient care, and although it is well known that comorbid sleep disorders in depression often persist after treatment of depression and also increase the risk of new depressive episodes, the availability of effective, evidence-based treatments for sleep disorders in hospitalised patients is very limited.
The overall goal of the current project is to translate, adapt and evaluate an acute psychological sleep treatment based on cognitive behavioural therapy for insomnia (CBT-I) for patients hospitalized with depression and comorbid sleep problems in the specialized psychiatric inpatient care in the Stockholm Region. The main hypothesis for the study is that acute psychological sleep stabilization (APS) reduces self-reported sleep complains compared to care as usual reinforced with sleep hygiene advice, and secondary hypotheses are that APS also leads to reduced depressive symptoms and earlier discharge.
The project includes a pilot study, which will be followed by a randomized, controlled trial of APS compared to care as usual with structured sleep hygiene (minimal active control) and treatment effect is evaluated every three days during the hospital stay and 1,2,4 and 12 weeks after randomization. APS will be performed by existing staff in the department with the support of a psychologist.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Admitted to the psychiatric inpatient care (Psykiatri Sydväst)
- •Depressive symptoms / confirmed depressive episode (uni- or bipolar)
- •Reports or is observed to have sleep problems in the form of insomnia, hypersomnia or delayed circadian phase
- •Knowledge of Swedish or English that is deemed sufficient to undergo the treatment
- •Consent to be included in the study and is judged to have understood what the study entails (care according to the Compulsory Psychiatric Care Act is not in itself an exclusion criterion)
排除标准
- •Intellectual disability
- •Severe somatic comorbidity with life expectancy <6 months
- •Ongoing mania / mixed-state
- •Complex problems that make APS impossible or inappropriate
- •Expected discharge within 3 days
研究组 & 干预措施
Acute psychological sleep stabilization
The basis of the treatment is CBT-I adapted to a short version performed by trained staff (nurses or mental health care assistants) together with a psychologist. The manuals are designed to be read by patients and staff together and each treatment manual covers a specific topic. The focus of the treatment is behavioral changes and central manuals are stimulus control and scheduled sleep and sleep compression (if needed).
干预措施: Acute psychological sleep stabilization (Behavioral)
Sleep hygiene education
The control treatment is delivered through structured manuals which patients work through together with the staff. The manuals cover sleep hindering factors (eg coffee, nicotine), sleep promoting factors (eg physical activity during the day, relaxation, blinds), sleep aids (for example, weight blanket, calm music).
干预措施: Sleep hygiene education (Behavioral)
结局指标
主要结局
Insomnia Severity Index
时间窗: 2 weeks post randomization (secondary timepoints include day 4, 7, 10 and week 4 and 12)
A self-report measure of insomnia symptoms. 7-item, self-rated questionnaire measuring insomnia severity. Total score 0-28, higher score indicates more severe sleep problems.
次要结局
- Generalised Anxiety Disorder 7-item scale (GAD-7)(Day 4, 7, 10 14 and week 4 and 12 post randomisation)
- European Quality of Life 5 Dimensions scale (EQ-5D)(Week 2, 4 and 12 post randomisation)
- Patient Health Questionnaire (PHQ-9)(Day 4, 7, 10 14 and week 4 and 12 post randomisation)
研究者
Sandra Tamm
M.D., PhD
Karolinska Institutet