Department of Clinical, Neuro-, and Developmental Psychology, Amsterdam Public Health Research Institute, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.
Jonx, Department of (Youth) Mental Health and Autism, Autism Team Northern-Netherlands, Lentis Psychiatric Institute, Laan Corpus Den Hoorn 102-2, 9728 JR Groningen, the Netherlands; Department of Psychology, Clinical Psychology and Experimental Psychopathology Unit, University of Groningen, Broerstraat 5, 9712 CP Groningen, the Netherlands.
Contemp Clin Trials. 2024 Nov;146:107704. doi: 10.1016/j.cct.2024.107704. Epub 2024 Sep 30.
Sleep problems, especially insomnia, are prevalent among autistic adults, affecting about 60 %, and significantly impact their quality of life. Internet-based cognitive behavioral therapy for insomnia (iCBT-I) could provide accessible and scalable treatment. Given the unique sensory- and information processing, and social challenges at play in autism, a tailored treatment approach may be essential to tackle sleep problems. Yet, interventions developed and tested specifically for autistic adults were scarce. Addressing this gap is crucial to meet the urgent need for effective insomnia treatments in this population.
With this two-arm, parallel, superiority randomized controlled trial, we will assess the effectiveness of a guided iCBT-I intervention for adults (N = 160) with autism and insomnia (i-Sleep Autism). In co-creation, i-Sleep Autism has been adjusted from an existing intervention (i-Sleep). Inclusion criteria are: age ≥ 18, an ASD diagnosis, and at least sub-threshold insomnia (Insomnia Severity Index ≥10). Participants are randomly assigned to either i-Sleep Autism or an information only waitlist control condition (online psychoeducation and sleep hygiene). After 6 weeks, the control group receives the intervention. Insomnia severity is the primary outcome. Secondary outcomes include pre-sleep arousal, general mental health, depression, anxiety, daily functioning, and quality of life. Assessments will occur at baseline, mid-intervention (3 weeks), post-intervention (6 weeks), and at 6-month follow-up (the intervention group). Linear mixed-effect regression models are employed to evaluate the effectiveness of i-Sleep Autism, alongside exploration of potential moderators and mediators.
This trial can reveal whether autistic adults with insomnia benefit from a guided e-health intervention.
NL-OMON56692.
睡眠问题，尤其是失眠，在自闭症成年人中很常见，患病率约为 60%，显著影响他们的生活质量。基于互联网的认知行为疗法治疗失眠（iCBT-I）可以提供便捷且可扩展的治疗。鉴于自闭症患者在感官和信息处理以及社交方面存在独特的挑战，量身定制的治疗方法可能对于解决睡眠问题至关重要。然而，针对自闭症成年人开发和测试的干预措施却很少。解决这一差距对于满足该人群对有效失眠治疗的迫切需求至关重要。
本研究采用两臂、平行、优势随机对照试验，评估针对自闭症和失眠成年人的 iCBT-I 干预（i-Sleep Autism）的有效性。i-Sleep Autism 是在现有的干预措施（i-Sleep）的基础上共同创建的。纳入标准为：年龄≥18 岁、自闭症谱系障碍（ASD）诊断和至少亚阈值失眠（失眠严重指数≥10）。参与者被随机分配到 i-Sleep Autism 或仅信息等待名单对照条件（在线心理教育和睡眠卫生）。6 周后，对照组接受干预。失眠严重程度是主要结局。次要结局包括睡前觉醒、一般心理健康、抑郁、焦虑、日常功能和生活质量。评估将在基线、干预中期（3 周）、干预后（6 周）和 6 个月随访（干预组）进行。线性混合效应回归模型用于评估 i-Sleep Autism 的有效性，同时探索潜在的调节因素和中介因素。
本试验可以揭示自闭症成年失眠患者是否受益于有指导的电子健康干预。
NL-OMON56692。
