The AkuSleep Study- Treating Sleep Disturbances in Patients With Psychotic Symptoms in an Acute Ward Setting Using Cognitive Behavioral Treatment Techniques
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Assessment of sleep
研究概览
简要总结
Sleep disturbance is recognized as a major problem for patients with psychosis and is seen in nearly all patients admitted in acute crisis to a psychiatric hospital.
Cognitive behavioral treatment is recommended as first-line treatment for insomnia in national and international guidelines. This study explores effect of adapting the milieu therapy to comply with the principles of CBT for insomnia. Our aim is to rethink our day to day psychological interventions and our around the clock milieu therapy for patients with acute and severe mental illness in light of established knowledge on how sleep is obtained and maintained.
详细描述
Sleep disturbances are highly prevalent among patients admitted to any hospital ward, but in particular in psychiatric patients where insomnia and poor sleep quality is a major clinical challenge.
Approximately 950 patients are admitted to The Acute Psychiatric Department at Oslo University each year. The majority of the patients (approximately 450) admitted for more than 48 hours have a severe psychotic disorder and after being evaluated by a psychiatrist upon admittance, they are allocated to one of three similar wards specialized in the treatment of psychosis. A majority of the patients experience sleep difficulties both in terms of insomnia and problems regulating circadian rhythm. Psychiatric wards in general offer several challenges to sleep, including limited access to natural daylight, noisy environment and frequent observations by staff during night for risk management purposes. A part from offering medication which the patient often declines, staff members possess little means as to how to cope with noise and agitation at night time due to frustrated patients unable to find rest.
In September 2019 our department started organizing the treatment for psychotic patients in three similar wards ("psychosis wards") and patients were allocated to a ward according to their date of birth. Nurses are stationed permanently at each ward, while psychiatrist and psychologists make up a "specialist pool" serving all three psychosis wards. One of the main intentions for organizing the department and treatment this way is to ensure that all patients with psychotic disorders receive the same treatment according to recommended guidelines.
The aim of our study is to rethink our day to day psychological interventions and our around the clock milieu therapy for our patients with acute and severe mental illness in light of established knowledge on how sleep is obtained and maintained. After making physical adjustments to the ward environment and training allocated nurses in modified CBT techniques, the AkuSleep intervention will start up in March 2020 and will be carried out for up to six months. All patients admitted one of the psychosis wards will be offered the same customized treatment focusing on sleep, whereas all the patients admitted to the other two psychosis wards will receive treatment as usual (TAU). Upon discharge, all patients admitted to the Department of Acute Psychiatry who are able to give informed consent are asked to give a broad consent allowing us to systemize clinical information from hospital records for research purposes.
The AkuSleep protocol is as follows:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 95 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients admitted to th he Acute Psychiatric Department at Oslo University who are able to consent
排除标准
- •Patients not able to consent
结局指标
主要结局
Assessment of sleep
时间窗: 10 months
Nursing staff report hours of sleep and number of awakening based on their observations which are recorded in the clinical record by night staff. All patients who receive treatment will be offered the opportunity to keep a sleeping diary for psycheducative purposes. The patients who are able to, will fill out the Insomnia Severity Index which is a brief instrument for assessment of sleep disturbances. In addition all patients, except those who cannot wear one for security reasons, will be offered an actigraph which provides the patient with a clear picture of their sleeping pattern. Relevant data from these actigraphs will be noted in the patients' clinical records.
次要结局
- Mania symptoms(10 months)
- Depressive symptoms(10 months)
- Nursing category (PK-score)(10 months)
- Number of days of stay.(10 months)
- Average bed days per ward.(10 months)
- Aggressive events(10 months)
- Disease severity(10 months)
- Psychotic symptoms(10 months)
- Brøset Violence Checklist (BVC)(10 months)
- Medication(10 months)
- Patient satisfaction(10 months)
- Psychosocial functioning(10 months)
研究者
Ingrid Dieset
MD, PhD
Oslo University Hospital
