Efficacy of a multicomponent psychological intervention for children with insomnia - randomized con-trolled trial including 3 months follow-up

大约15%的学龄前儿童和学龄儿童受到失眠的影响。症状通常是难以入睡和维持睡眠。如果不进行治疗，儿童早期的睡眠障碍在40%以上的病例中持续存在。睡眠障碍的后果是白天困倦，认知能力下降和学习问题，内化和外化行为，以及更高的自杀风险。此外，成年后抑郁和焦虑症的风险也会增加。对于5至10岁的年龄组，没有基于手册的心理治疗，包括儿童及其父母。因此，我们小组开发了一种包含认知行为、催眠治疗和教育成分的非药物、心理治疗(KISS)。在一项先导性研究中，这种治疗方案导致治疗组睡眠问题的减少明显大于等待名单对照组(Schlarb等人，2011年)。基于这些初步结果，我们现在申请一项随机、对照、大型结局研究，并假设在患有失眠的儿童(5-10岁)中，治疗在减少睡眠问题方面将优于心理教育(PE)和等待名单对照组(WL)。作为主要的结果衡量标准，我们期望通过肌动描记术测量的睡眠开始潜伏期减少。作为次要结果指标，我们进一步预测治疗组夜间觉醒次数减少，夜间恐惧和睡前挣扎减少，缓解率(短期和长期)更高，白天嗜睡更少，注意力更集中。此外，我们预测父母的睡眠、心理健康将显著改善，抑郁症状将减少，特别是对母亲来说。

Approximately 15% of preschool and school children are affected by insomnia. Symptoms are usually difficulties initiating and maintaining sleep. Without treatment, sleep disturbances in early childhood persist in more than 40% of the cases. Consequences of disturbed sleep are daytime sleepiness, im-paired cognitive performance and school problems, internalizing and externalizing behaviour and a higher risk for suicide. Furthermore, the risk increases for adulthood depression and anxiety disorders. For the age group of 5 to 10 years, no manual based psychological treatment, including children and their parents, is available. Therefore, our group developed a non-pharmacological, psychological treatment with cognitive-behavioural, hypnotherapeutic and educational components (KiSS). In a pilot-study this treatment program led to a significantly larger reduction of sleep problems in the treatment group than in the waiting list control group (Schlarb et al., 2011). Based on these preliminary results we now apply for a randomized, controlled, large outcome study and assume that in children (aged 5-10 years) with insomnia the treatment will be superior in reducing sleep problems to psychoeducation (PE) and a waiting list control group (WL). As primary outcome measure, we expect reduced sleep onset latency as measured with actigraphy. As secondary outcome measures we further predict for the treatment group reduced number of night-time awakenings, less night-time fears and bedtime struggles, higher remission rates (short- and long-term), less daytime sleepiness and higher level of attention. Additionally, we predict a significant improvement of parental sleep, psychological wellbeing and a reduction of depressive symptoms, specifically for mothers.