Digital Mood-enhanced CBT-I to Improve Depressive Symptoms in Adolescents
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Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Standard dCBT-I, Modified Mood enhanced CBT-I (M-dCBT-I).
- Кому может быть актуально
- Состояния в реестре: Insomnia, Depression, Adolescent. Базовые параметры: 12 лет — 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
- Гонконг
- Следующий шаг
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Официальное название
Effect of a Smartphone-based, Mood-enhanced Cognitive Behavioral Therapy for Insomnia in Adolescents At Risk of Depression: A Cluster Randomized Trial
Обзор
Emerging encouraging evidence showed that sleep focused treatment can simultaneously improve sleep and depression in adult with comorbid conditions. Although these favorable changes in depressed adults is encouraging, little is known in the potential efficacy of CBT-I in altering depression trajectory in adolescent population. This current study aims to compare the effect of digitally delivered, mood enhanced cognitive behavioral therapy for insomnia (M-dCBT-I) and standard digital cognitive behavioral therapy for insomnia (dCBT-I) in improving depressive symptoms in adolescents, and to examine the potential sustained treatment effect in mood outcomes following M-dCBT-I or dCBT-I treatment.
Подробное описание
Adolescence is a critical transitional stage accompanied by the emergence of mental disorders, with major depressive disorder (MDD) being the most common mental disorder. The point prevalence of depression ranges from 3% to 18% across different studies. In addition, according to our previous studies, approximately 10% of adolescents experience insomnia disorders, and 36% have insomnia symptoms. Adolescent concurrently experiencing sleep and mood problems are typically at a higher risk of adverse health outcomes. This particular group is usually much more difficult to treat, with a poorer prognosis, suggesting that this group maybe in particular need for effective treatment.
There is accumulating evidence that adolescent sleep and mood problems can be treated successfully using cognitive behavioral therapy (CBT), which is one of the most extensively evaluated non-pharmacological approach for managing either depression or insomnia symptoms in adolescents. Cognitive behavioral therapy for depression (CBT-D) involves psychoeducation and addresses cognitive restructuring for unrealistic thinking contribute to depressed mood and behavioral strategies to increase pleasant activities. While cognitive behavioral therapy for insomnia (CBT-I) is the first-line treatment in managing adult insomnia, it has gained increasing empirical evidence in managing adolescent insomnia. The high comorbidity of insomnia and depression calls for the need for addressing both problems due to the fact that residual insomnia or residual depressive symptoms could further hasten a relapse to the other comorbid disorder. In addition, depression becomes more difficult to treat in the presence of insomnia. In fact, there has, however, been emerging encouraging evidence showing that sleep focused treatment can simultaneously improve sleep and depression in adult with comorbid conditions. Although these favorable changes in depressed adults is encouraging, little is known in the potential efficacy of CBT-I in altering depression trajectory in adolescent population.
This current study aims to compare the effect of digitally delivered, mood enhanced cognitive behavioral therapy for insomnia (M-dCBT-I) and standard digital cognitive behavioral therapy for insomnia (dCBT-I) in improving depressive symptoms in adolescents, and to examine the potential sustained treatment effect in mood outcomes following M-dCBT-I or dCBT-I treatment. Primary outcomes include the depressive symptoms as measured by PHQ-9, while secondary outcomes include clinician rated depression scale (HRSD), insomnia (ISI), sleep-related measures (Sleep diary variables, dysfunctional sleep belief), daytime sleepiness, anxiety (HADS), quality of life (Kidscreen-27). Outcome measurement will be conducted at baseline, postintervention, 6-month and 12-month follow up.
Вмешательства
- Поведенческое Standard dCBT-I
This standard digital CBT-I intervention will cover (1) psycho-education about sleep, circadian and sleep hygiene education, (2) stimulus control, (3) sleep restriction, (4) relaxation techniques, (5) structured worry time, (6) cognitive restructuring (targeting sleep-related dysfunctional cognitions), and (7) relapse prevention. In order to have comparable dosage as modified CBT-I, the treatment will be dispersed to 8 modules (8-week) which is still in the range of standard CBT-I duration (usua - Поведенческое Modified Mood enhanced CBT-I (M-dCBT-I)
Additional depression specific components will be added to the standard CBT-I, including behavioral activation and problem solving.
Первичные конечные точки
- Depressive symptoms [Срок оценки: Baseline, Postintervention (8 weeks), 6-month follow up and 12-month follow up]
Вторичные конечные точки (8)
- Assessor-rated depressive symptomatology [Срок оценки: Baseline, Postintervention (8 weeks), 6-month follow up and 12-month follow up]
- Overall severity of depression symptoms [Срок оценки: Baseline, Postintervention (8 weeks), 6-month follow up and 12-month follow up]
- Severity of insomnia symptoms [Срок оценки: Baseline, Postintervention (8 weeks), 6-month follow up and 12-month follow up]
- Sleep-wake pattern [Срок оценки: Baseline, Postintervention (8 weeks), 6-month follow up and 12-month follow up]
- Sleep-related beliefs and cognitions [Срок оценки: Baseline, Postintervention (8 weeks), 6-month follow up and 12-month follow up]
- Daytime sleepiness [Срок оценки: Baseline, Postintervention (8 weeks), 6-month follow up and 12-month follow up]
- Anxiety and depression symptoms [Срок оценки: Baseline, Postintervention (8 weeks), 6-month follow up and 12-month follow up]
- Quality of life by KIDSCREEN-27 [Срок оценки: Baseline, Postintervention (8 weeks), 6-month follow up and 12-month follow up]
Критерии участия
Критерии включения
- Chinese adolescent aged 12-18 years old
- presence of insomnia problems as defined by insomnia severity index ≥ 9 (locally validated cut off for detecting clinical insomnia in adolescents)
- presence of depressive problems as defined by Patient Health Questionnaire-9 (PHQ-9) using cut off of 10 for detecting clinical depression
- ability to read and understand Chinese
- possession of smartphone
Критерии исключения
- presence of prominent suicidality (suicide plans and suicide attempts) as determined by the Mini-International Neuropsychiatric Interview (MINI)
- a clinical diagnosis of psychosis, schizophrenia, bipolar disorders, or intellectual disability
- presence of other sleep disorders that significantly affect sleep continuity or sleep quality (e.g. restless leg symptoms or obstructive sleep apnea syndrome) as determined by validated Diagnostic Interview for Sleep Patterns and Disorders
- currently receiving psychological treatment for insomnia and/or pharmacological treatment for depression
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
- Двойное слепое
- Основная цель
- Лечение
Центры проведения
Гонконг · 1 центр
- Department of Psychiatry, the Chinese University of Hong Kong — Shatin
Идентификаторы
NCT: NCT06358898 · 20221207