Become Your Own SLEEPexpert: a Behavioral Treatment Program for Insomnia in Patients With Psychiatric Disorders
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change in Insomnia Severity Index (ISI)
研究概览
简要总结
Comorbid insomnia represents a frequent health problem in patients with severe mental disorders, and cognitive behavioral therapy for insomnia (CBT-I) has been identified as the first line treatment. However, CBT-I has not sufficiently been implemented in acute psychiatry settings. Rather, patients are often overtreated with benzodiazepines or benzodiazepine receptor agonists, related to adverse effects and the risk of tolerance and dependency. This work aims to empower patients with severe mental disorders to take care of their own sleep health based on a pragmatic behavioral treatment program ("Become your own SLEEPexpert"). Implementation research strategies in collaboration with patients and health care providers were used to adaptat CBT-I components to the needs of psychiatric inpatients. Evidence for feasibility in an acute hospital setting and preliminary evidence for efficacy has been shown. ln the proposed project, the investigators aim to compare treatment as usual (TAU) + SLEEPexpert to TAU + sleep monitoring in a pilot randomized controlled trial. The objective is to target sleep to improve mental health and to investigate the efficacy of the SLEEPexpert programme for the improvement of sleep and mental health. Given the high burden of comorbid insomnia in psychiatry, the investigators believe that the presented work is of interest to basic scientists and clinicians and, potentially, of heightened public health relevance.
详细描述
- Standard operating procedures: patient recruitment
During the enrolment phase, all patients admitted to the participating wards of the UPD Bern will be screened in person. The screening will consist of a few questions regarding sleep, implemented into the routine clinical interview at enrolment, and filling in the insomnia severity index. Eligible patients will be contacted by study staff, informed about the study, and invited to participate. For further information about the study, a flyer containing the most important details will be given to the participants. The screening and enrolment process will be standardized across the wards to minimize the risk of selection bias.
- Standard operating procedures: data collection & data management Source data verification Quality assurance: data validation & registry procedures
Data is recorded and collected in paper CRFs as source documents. ECRFs will be given as an option for direct anonymized data entry from participants if feasible. The eCRFs will be created and stored on the database RedCap which is a database recommended by the Clinical Trial Unit Bern. Data entry from the source paper CRFs to eCRFs should only be performed by authorized personnel and data should be consistent with the available source documents. When this is not the case, a detailed explanation of the discrepancies should be provided. The principal investigator should ensure the accuracy, completeness, and timeliness of the data reported and sign off the completed eCRFs. In order to reflect the current patient status throughout the study, eCRFs will be kept up to date. This means that eCRFs should be completed no later than two weeks after a participant's visit and that data entry not should be delayed unnecessarily.
- Data checks
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Study participants and care providers cannot be blinded because they will notice whether they receive / deliver an actual treatment or a monitoring control. Due to the crossover cluster design (randomization of wards to either TAU plus sleep monitoring or TAU plus SLEEPexpert), patients who are on the same ward at the same time will not get in contact with patients who are in the other arm. Thus, contamination due to exchange between patients will be reduced as far as possible.
Outcome assessors (interviewers) and data analysts will be blinded. In the respective documents and database entries, patients will be identified with a code. The key for assigning the codes to patients will not be known to the interviewers and data analysts.
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
- •Age 18 years or older
- •Documented diagnosis of acute insomnia, i.e. insomnia criteria according to ICD-10 for at least 2 weeks
- •Insomnia Severity Index (ISI) total score ≥ 8, equivalent to relevant insomnia
- •Inpatient in one of the two participating psychiatric wards in the UPD Bern
- •Ability to understand the aims and procedures of the study
- •Willingness to participate and ability to provide written informed consent
排除标准
- •Incabability of judgement
- •Inability to participate in a low-threshold behavioral treatment program, e.g. due to severe cognitive impairment or high symptom severity precluding participation (e.g., severe catatonic symptoms, massive hallucinations, acute endangerment to self or others, involuntary commitment). Note that the named symptoms will lead to exclusion only if they lead to inability to give informed consent or an inability to participate in the program. Excluded patients will be re-assessed regularly and included if symptoms improve and participation is possible at a later point in time.
结局指标
主要结局
Change in Insomnia Severity Index (ISI)
时间窗: change from time point T0 (study start) to T1 ( week 1),T2(week2), T3 (week12), T4 (week26)
The Insomnia Severity Index (ISI) is a valid, reliable and change-sensitive self-rating questionnaire that is widely used as an outcome measure in clinical trials in insomnia research (scores from 0 to 28 with higher values indicative for more severe insomnia).
次要结局
- Change in Brief Symptom Inventory (BSI) 18-items(change from time point T0 (study start) to T2 (week 2) and T4 (week26))
研究者
Christoph Nissen
Professor
University of Bern