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Набор скоро начнётся NCT03624400

Internet-delivered Cognitive Behaviour Therapy for Sleep Problems in ASD

Без фазы С лечением Autism Spectrum Disorder Sleep Disturbance Insomnia

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: Internet-based CBT-I, Internet-based psychoeducation.
Кому может быть актуально
Состояния в реестре: Autism Spectrum Disorder, Sleep Disturbance, Insomnia. Базовые параметры: 13 лет — 17 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
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Официальное название

Internet-delivered Cognitive Behaviour Therapy for Sleep Problems in Adolescents with Autism Spectrum Disorder

Обзор

This trial investigates the behavioural effects of Internet-based Cognitive behaviour therapy for insomnia (CBT-I) in adolescents with autism spectrum disorder with sleep problems. This is a randomised controlled trial.

Подробное описание

Sleep problems are common in adolescents with autism spectrum disorder (ASD)1. Internet-based Cognitive behaviour therapy for insomnia (iCBT-I) is considered as an evidence-based treatment for insomnia 2. To date, no Internet-based CBT-I delivered treatment for sleep problems in adolescents with ASD has been undertaken. The objective of the study is to investigate the efficacy and effectiveness of the Internet-based CBT-I for sleep problems in adolescents with ASD.

Вмешательства

  • Поведенческое Internet-based CBT-I
    The adapted Internet-based CBT-I for adolescents with ASD includes sleep hygiene, restriction of time in bed, stimulus control, cognitive therapy, and relaxation techniques. The treatment consists of 8 weekly modules and each module consists of several website pages that will be presented in a fixed order, with preprogrammed modules containing information, interactive questionnaires, descriptions of exercises and movies.
  • Поведенческое Internet-based psychoeducation
    Internet-based psychoeducation contains information about ASD, sleep difficulties and aspects of sleep hygiene. The intervention takes place in 8 weeks modules.

Первичные конечные точки

  • Change in sleep impairment by using The Insomnia Severity Index (ISI) [Срок оценки: Baseline, post intervention (8 weeks), 3 months post intervention follow-up and 6 months post intervention follow-up]
Вторичные конечные точки (5)
  • Sleep diaries by using Actigraphy [Срок оценки: Baseline, post intervention (8 weeks), 3 months post intervention follow-up and 6 months post intervention follow-up]
  • Quality of sleep by using Athens Insomnia Scale (AIS) [Срок оценки: Baseline, post intervention (8 weeks), 3 months post intervention follow-up and 6 months post intervention follow-up]
  • Everyday functioning by using Developmental disabilities modification of the Children's Global Assessment scale (DD-CGAS) [Срок оценки: Baseline, post intervention (8 weeks), 3 months post intervention follow-up and 6 months post intervention follow-up]
  • Anxiety problems by using Spence Children's Anxiety Scale [Срок оценки: Baseline, post intervention (8 weeks), 3 months post intervention follow-up and 6 months post intervention follow-up]
  • Emotion regulation difficulties by using The brief version of Difficulties in Emotion Regulation Scale (DERS-16) [Срок оценки: Baseline, post intervention (8 weeks), 3 months post intervention follow-up and 6 months post intervention follow-up]

Критерии участия

Критерии включения

  • Adolescents with a clinical ASD diagnosis based on the Diagnostic and Statistical Manual-fifth edition (DSM-5). Participants have been investigated with the Autism Diagnostic Observation Schedule (ADOS).
  • Insomnia diagnosis or sleep problems according to DSM-5
  • Intelligence quotient (IQ) > 70 according to Wechsler Intelligence Scale for Children - fourth edition
  • Psychiatric comorbidities according to DSM-5: anxiety disorders or depression.

Критерии исключения

  • The presence of clinically assessed self-injury
  • High risk of suicidal behaviour
  • borderline personality disorder or any form of schizophrenia or related disorders;
  • substance abuse as well as physical illness or condition that was largely influence sleep condition.

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
Тройное слепое
Основная цель
Лечение

Центры проведения

Швеция · 1 центр
  • Nora Choque Olsson — Stockholm

Публикации

  • Owens J. Classification and epidemiology of childhood sleep disorders. Prim Care. 2008 Sep;35(3):533-46, vii. doi: 10.1016/j.pop.2008.06.003. PMID 18710669
  • Bastien CH, Morin CM, Ouellet MC, Blais FC, Bouchard S. Cognitive-behavioral therapy for insomnia: comparison of individual therapy, group therapy, and telephone consultations. J Consult Clin Psychol. 2004 Aug;72(4):653-9. doi: 10.1037/0022-006X.72.4.653. PMID 15301650
  • Georen L, Jansson-Frojmark M, Nordenstam L, Andersson G, Olsson NC. Internet-delivered Cognitive Behavioral Therapy for insomnia in youth with autism spectrum disorder: A pilot study. Internet Interv. 2022 May 23;29:100548. doi: 10.1016/j.invent.2022.100548. eCollection 2022 Sep. PMID 35651733

Идентификаторы

NCT: NCT03624400 · Sleep Good Autism

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗