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Идёт набор NCT05177055

Sleep in Psychiatric Care (SIP): Treatment for Comorbid Delayed Sleep-Wake Phase Disorder (DSWPD)

Без фазы С лечением Delayed Sleep-Wake Phase Disorder Sleep Disorder Psychiatric Disorder

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 light therapy at gradually advanced timing for DSWPD, Group-based light therapy at gradually advanced timing for DSWPD and additive bb-glasses, 6-week wait list for sleep-school.
Кому может быть актуально
Состояния в реестре: Delayed Sleep-Wake Phase Disorder, Sleep Disorder, Psychiatric Disorder. 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 (SIP): A Transdiagnostic Group-based Sleep-school as Treatment for Comorbid Delayed Sleep-Wake Phase Disorder (DSWPD)

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 recommended treatment for Delayed Sleep-Wake phase disorder is light therapy at gradually advanced timing and/or melatonin administered in order to help phase-advance the circadian rhythm. There is a great gap in the knowledge on how sleep disorders can be treated effectively when they occur comorbid to moderate and severe psychiatric illness. In this project the we therefore seek to investigate the effect of psychological and behavioural, group-based treatment in a randomized controlled trial (RCT) where sleep and psychiatric symptoms are the primary outcome measures.

Подробное описание

The recommended treatment for Delayed Sleep-Wake phase disorder is bright light therapy (LT) at gradually advanced timing and/or melatonin administered in order to phase-advance the circadian rhythm. 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 advancing effect on the circadian rhythm. The investigators therefore also want to test bb-glasses as an additive treatment to LT at gradually advanced timing.

The sleep-school at Bjørgvin District Psychiatric Hospital (DPS) is an already established treatment since 2017. The DSWPD-group gets together every other Monday from 1 pm until 3 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 treatment, this often leads the group to function as a support for each other. Participants are patients at the general psychiatric outpatient clinic at Bjørgvin DPS in Bergen, Norway. Participants 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, hence the project has high ecological validity.

All participants have an individual consultation before joining the group where the focus is on eligibility to participate in the group-based treatment, sleep-diagnostic evaluation, receive a standardized education on sleep-regulation and sleep hygiene advice and receive a date to start the group-based LT at gradually advanced timing. 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 6 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 on 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, hence both groups are in active treatment for their symptoms. Participants that start sleep-school as soon as possible, are also allocated to a) ordinary group-based LT at gradually advanced timing for 6 weeks or b) group-based group-based LT at gradually advanced timing for 6 weeks and bb-glasses. All participant will be followed up after 12 months.

Вмешательства

  • Поведенческое Group-based light therapy at gradually advanced timing for DSWPD
    Light therapy at gradually advanced timing, Sleep education, sleep hygiene, cognitive restructuring, relaxation techniques
  • Поведенческое Group-based light therapy at gradually advanced timing for DSWPD and additive bb-glasses
    Light therapy (LT) at gradually advanced timing, bb-glasses 12 hrs after LT, Sleep education, sleep hygiene, cognitive restructuring, relaxation techniques
  • Другое 6-week wait list for sleep-school
    Treatment as usual in a psychiatric outpatient clinic

Первичные конечные точки

  • Changes (advancement) of sleep timing [Срок оценки: baseline, post intervention after 6 weeks, follow-up after 12 months]
Вторичные конечные точки (12)
  • Changes in objective sleep onset latency (SOL) [Срок оценки: baseline and post intervention after 6 weeks, follow-up after 12 months]
  • Changes in Sleep efficiency (SE) [Срок оценки: baseline, bi-weekly assesment and post intervention after 6 weeks, follow-up after 12 months]
  • Changes in Time in bed (TIB) [Срок оценки: baseline, bi-weekly assesment and post intervention after 6 weeks, follow-up after 12 months]
  • Changes in immediate sleepiness [Срок оценки: baseline, bi-weekly assesment and post intervention after 6 weeks, follow-up after 12 months]
  • Changes in objective total sleep length/time asleep (TST) [Срок оценки: baseline and post intervention after 6 weeks, follow-up after 12 months]
  • Work status [Срок оценки: baseline and post intervention after 6 weeks, follow-up after 12 months]
  • Changes in Total sleep length/time asleep (TST) [Срок оценки: baseline, bi-weekly assesment and post intervention after 6 weeks, follow-up after 12 months]
  • Changes in Early morning awakening (EMA) [Срок оценки: baseline, bi-weekly assesment and post intervention after 6 weeks, follow-up after 12 months]
  • Changes in objective sleep efficiency (SE) [Срок оценки: baseline and post intervention after 6 weeks, follow-up after 12 months]
  • Changes in objective early morning awakening (EMA) [Срок оценки: baseline and post intervention after 6 weeks, follow-up after 12 months]
  • Changes in well-being [Срок оценки: baseline and post intervention after 6 weeks, follow-up after 12 months]
  • Changes in sleepiness [Срок оценки: baseline, bi-weekly assesment and post intervention after 6 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 DSWPD 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 DSWPD 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

  • Night work
  • Patients that do not fulfil the DSM-V criteria for DSWPD 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 · 2 центра
  • Haukeland University Hospital — Bergen
  • Haukeland University Hospital — Bergen

Публикации

  • Wilhelmsen-Langeland A, Osnes B, Gradisar M, Vagenes VA, Sorensen L, Bjorvatn B, Fasmer OB, Koenig J, Pallesen S, Saxvig IW. Group bright light therapy compared to treatment as usual for delayed sleep-wake phase disorder among patients in psychiatric care (the SIP trials): a protocol for a pragmatic, randomised controlled trial. BMJ Open. 2025 Apr 17;15(4):e093091. doi: 10.1136/bmjopen-2024-093091 PMID 40250869

Идентификаторы

NCT: NCT05177055 · 66304-2

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗