Набор по приглашению NCT06145555

Acute Psychological Sleep Stabilisation for Patients Hospitalised With Depression

Без фазы С лечением Insomnia Depression

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: Acute psychological sleep stabilization, Sleep hygiene education.
Кому может быть актуально: Состояния в реестре: Insomnia, Depression. Базовые параметры: от 18 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: Швеция
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

Disturbed sleep occurs in almost all patients in psychiatric inpatient care, and although it is well known that comorbid sleep disorders in depression often persist after treatment of depression and also increase the risk of new depressive episodes, the availability of effective, evidence-based treatments for sleep disorders in hospitalised patients is very limited. The overall goal of the current project is to translate, adapt and evaluate an acute psychological sleep treatment based on cognitive behavioural therapy for insomnia (CBT-I) for patients hospitalized with depression and comorbid sleep problems in the specialized psychiatric inpatient care in the Stockholm Region. The main hypothesis for the study is that acute psychological sleep stabilization (APS) reduces self-reported sleep complains compared to care as usual reinforced with sleep hygiene advice, and secondary hypotheses are that APS also leads to reduced depressive symptoms and earlier discharge. The project includes a pilot study, which will be followed by a randomized, controlled trial of APS compared to care as usual with structured sleep hygiene (minimal active control) and treatment effect is evaluated every three days during the hospital stay and 1,2,4 and 12 weeks after randomization. APS will be performed by existing staff in the department with the support of a psychologist.

Вмешательства

Поведенческое Acute psychological sleep stabilization
See above (arm description)
Поведенческое Sleep hygiene education
See above (arm description)

Первичные конечные точки

Insomnia Severity Index [Срок оценки: 2 weeks post randomization (secondary timepoints include day 4, 7, 10 and week 4 and 12)]

Вторичные конечные точки (3)

Patient Health Questionnaire (PHQ-9) [Срок оценки: Day 4, 7, 10 14 and week 4 and 12 post randomisation]
Generalised Anxiety Disorder 7-item scale (GAD-7) [Срок оценки: Day 4, 7, 10 14 and week 4 and 12 post randomisation]
European Quality of Life 5 Dimensions scale (EQ-5D) [Срок оценки: Week 2, 4 and 12 post randomisation]

Критерии участия

Критерии включения

Admitted to the psychiatric inpatient care (Psykiatri Sydväst)
Depressive symptoms / confirmed depressive episode (uni- or bipolar)
Reports or is observed to have sleep problems in the form of insomnia, hypersomnia or delayed circadian phase
Knowledge of Swedish or English that is deemed sufficient to undergo the treatment
Consent to be included in the study and is judged to have understood what the study entails (care according to the Compulsory Psychiatric Care Act is not in itself an exclusion criterion)