Sleep in Psychiatric Care: A Transdiagnostic Group-based Sleep-school as Treatment for Comorbid Insomnia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Insomnia symptoms
研究概览
简要总结
Sleep disorders commonly co-occur with psychiatric disorders. Sleep disorders are often treated with medication or not at all in psychiatric care, although there exist a plethora of documentation of the effectiveness of sleep interventions. There is also an increase in studies showing effectiveness of sleep-interventions when the sleep disorder co-occurs with psychiatric illness. The most common and best documented treatment for insomnia is cognitive behavioral therapy for insomnia (CBTi). There is a great gap in the knowledge on how sleep disorders can be treated effectively in psychiatric care. In this project the investigators therefore seek to investigate the effect of non-pharmacological, group-based treatment in a randomized controlled trial (RCT) where sleep and psychiatric symptoms are the primary outcome measures. CBTi comprise of sleep education, sleep restriction, stimulus control and cognitive restructuring of dysfunctional thoughts about sleep.
详细描述
The recommended treatment for insomnia is CBTi. Recent research has proven that dark therapy, or blocking light in wavelengths <530 nm by the use of for example orange blue-blocking glasses (bb-glasses), has shown the ability to maintain melatonin production comparable to darkness and to have an additive effect in the treatment of insomnia. The investigators therefore also want to test bb-glasses as an additive treatment to CBTi for insomnia.
The sleep-school at Bjørgvin District Psychiatric Hospital (DPS) is an already established treatment since 2017. The insomnia-group gets together every other Monday from noon until 2 pm. The group is open, which means that participants start at different dates and meet people in the group that might be at the end of their CBTi treatment. Participants are patients at the general psychiatric outpatient clinic at Bjørgvin DPS. Participant have been referred to the sleep-team by their psychologist or doctor. In this RCT the investigators will carry on the same structure for the group for participants that are recruited to the RCT.
All participants have an individual consultation before joining the group where the focus is on eligibility to participate in the group-based treatment, diagnostic evaluation, receive a standardized education on sleep-regulation and sleep hygiene advice and receive a date to start the group-based CBTi treatment. In a randomized manner, they will be allocated to the sleep-school group and start the treatment on the next possible date or to a 8 week wait-list and receive a date the treatment starts. All eligible participants will be informed that there may be a waitlist and receive a start-date without being informed that thay are in a waitlist group or not a waitlist group. All participants will be treated as usual (TAU) for their psychiatric problems parallel to either sleep-school or waitlist. Participants that start sleep-school as soon as possible, are also allocated to a) ordinary group-based CBTi 8 weeks or b) group-based CBTi 8 weeks and bb-glasses. All participant will be followed up after 12 months.
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 (Participant)
盲法说明
All eligible participants will be informed that there may be a waitlist (length not specified) and receive a start-date without being informed that thay are in a waitlist group or not a waitlist group.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients referred to the sleep-school at Bjørgvin DPS psychiatric hospital
- •Patients fulfilling the Diagnostic Manual for Mental Disorders (DSM-V) criteria for insomnia comorbid to moderate to severe psychiatric illness (confirmed F-diagnosis based on the International Statistical Classification of Diseases and Related Health Problems (ICD-11) diagnostic system that are used in Norway in addition to insomnia and/or scores of ≥19 on BDI and/or scores of ≥16 on BAI at the time of referral to the sleep school)
排除标准
- •Nightwork
- •Patients that do not fulfil the DSM-V criteria for insomnia comorbid to moderate to severe psychiatric illness (confirmed F-diagnosis based on the ICD-10 diagnostic system that are used in Norway in addition to insomnia and/or scores of ≥19 on BDI and/or scores of ≥16 on BAI at the time of referral to the sleep school)
结局指标
主要结局
Insomnia symptoms
时间窗: baseline, bi-weekly and post intervention after 8 weeks, follow-up after 12 months
Measured by the questionnaires Insomnia severity Index (ISI) and Bergen Insomnia Scale (BIS). From sleep diaries; sleep onset latency (SOL), wake after sleep onset (WASO) and sleep efficiency (SE).
次要结局
- Changes in objective wake after sleep onset (WASO)(baseline and post intervention after 8 weeks, follow-up after 12 months)
- Changes in Daytime function (DF)(baseline, bi-weekly assesment and post intervention after 8 weeks, follow-up after 12 months)
- Changes in objective sleep onset latency (SOL)(baseline and post intervention after 8 weeks, follow-up after 12 months)
- Changes in fatigue(baseline and post intervention after 8 weeks, and at follow-up after 12 months)
- Changes in insomnia severity(baseline and post intervention after 8 weeks, follow-up after 12 months)
- Changes in objective total sleep length/time asleep (TST),(baseline and post intervention after 8 weeks, follow-up after 12 months)
- Changes in Total sleep length/time asleep (TST)(baseline, bi-weekly assesment and post intervention after 8 weeks, follow-up after 12 months)
- Changes in Sleep quality (SQ)(baseline, bi-weekly assesment and post intervention after 8 weeks, follow-up after 12 months)
- Changes in beliefs and attitudes about sleep(baseline and post intervention after 8 weeks, follow-up after 12 months)
- Changes in Time in bed (TIB)(baseline, bi-weekly assesment and post intervention after 8 weeks, follow-up after 12 months)
- Changes in objective early morning awakening (EMA)(baseline and post intervention after 8 weeks, follow-up after 12 months)
- Changes in anxiety(baseline and post intervention after 8 weeks, follow-up after 12 months)
- Work status(baseline and post intervention after 8 weeks, and at follow-up after 12 months)
- Changes in insomnia diagnosis(baseline and post intervention after 8 weeks, follow-up after 12 months)
- Well-being(baseline and post intervention after 8 weeks, and at follow-up after 12 months)
- Changes in Early morning awakening (EMA)(baseline, bi-weekly assesment and post intervention after 8 weeks, follow-up after 12 months)
- Changes in objective time in bed (TIB)(baseline and post intervention after 8 weeks, follow-up after 12 months)
- Changes in objective sleep efficiency (SE)(baseline and post intervention after 8 weeks, follow-up after 12 months)
- Changes in depression(baseline and post intervention after 8 weeks, follow-up after 12 months)