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Идёт набор NCT04463498

Sleep in Psychiatric Care (SIP): A Transdiagnostic Group-based Sleep-school as Treatment for Comorbid Insomnia

Без фазы С лечением Sleep Disorder; Insomnia Type Psychiatric Disorders

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Group-based cognitive behavioral therapy for insomnia, Group-based cognitive behavioral therapy for insomnia and additive bb-glasses, 8-week wait list for sleep-school.
Кому может быть актуально
Состояния в реестре: Sleep Disorder; Insomnia Type, Psychiatric Disorders. Базовые параметры: 18 лет — 80 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Норвегия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Sleep in Psychiatric Care: A Transdiagnostic Group-based Sleep-school as Treatment for Comorbid Insomnia

Обзор

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.

Подробное описание

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.

Вмешательства

  • Поведенческое Group-based cognitive behavioral therapy for insomnia
    Sleep education, sleep restriction, stimulus control, cognitive restructuring, relaxation techniques
  • Поведенческое Group-based cognitive behavioral therapy for insomnia and additive bb-glasses
    Sleep education, sleep restriction, stimulus control, cognitive restructuring, relaxation techniques, bb-glasses worn from 3 hrs before bedtime.
  • Другое 8-week wait list for sleep-school
    Treatment as usual in a psychiatric outpatient clinic

Первичные конечные точки

  • Insomnia symptoms [Срок оценки: baseline, bi-weekly and post intervention after 8 weeks, follow-up after 12 months]
Вторичные конечные точки (12)
  • Changes in insomnia diagnosis [Срок оценки: baseline and post intervention after 8 weeks, follow-up after 12 months]
  • Changes in insomnia severity [Срок оценки: baseline and post intervention after 8 weeks, follow-up after 12 months]
  • Changes in Time in bed (TIB) [Срок оценки: baseline, bi-weekly assesment and post intervention after 8 weeks, follow-up after 12 months]
  • Changes in objective early morning awakening (EMA) [Срок оценки: baseline and post intervention after 8 weeks, follow-up after 12 months]
  • Changes in objective wake after sleep onset (WASO) [Срок оценки: baseline and post intervention after 8 weeks, follow-up after 12 months]
  • Changes in Early morning awakening (EMA) [Срок оценки: baseline, bi-weekly assesment and post intervention after 8 weeks, follow-up after 12 months]
  • Changes in objective time in bed (TIB) [Срок оценки: baseline and post intervention after 8 weeks, follow-up after 12 months]
  • Changes in objective sleep efficiency (SE) [Срок оценки: baseline and post intervention after 8 weeks, follow-up after 12 months]
  • Changes in objective total sleep length/time asleep (TST), [Срок оценки: baseline and post intervention after 8 weeks, follow-up after 12 months]
  • Changes in Total sleep length/time asleep (TST) [Срок оценки: baseline, bi-weekly assesment and post intervention after 8 weeks, follow-up after 12 months]
  • Changes in Sleep quality (SQ) [Срок оценки: baseline, bi-weekly assesment and post intervention after 8 weeks, follow-up after 12 months]
  • Changes in Daytime function (DF) [Срок оценки: baseline, bi-weekly assesment and post intervention after 8 weeks, follow-up after 12 months]

Критерии участия

Критерии включения

  • 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)

Критерии исключения

  • 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

Норвегия · 1 центр
  • Haukeland University Hospital — Bergen

Публикации

  • Wilhelmsen-Langeland A, Saxvig IW, Gradisar M, Vagenes VA, Pallesen S, Sorensen L, Fasmer OB, Koenig J, Bjorvatn B, Osnes B. Group cognitive behavioural therapy for insomnia compared with treatment as usual for sleep problems in psychiatric care (the SIP trials): a protocol for a pragmatic, randomised controlled trial. BMJ Open. 2025 Apr 17;15(4):e090997. doi: 10.1136/bmjopen-2024-090997. PMID 40250874

Идентификаторы

NCT: NCT04463498 · 66304

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗