Denis Dan, Eley Thalia C, Rijsdijk Fruhling, Zavos Helena M S, Keers Robert, Espie Colin A, Luik Annemarie I, Badini Isabella, Derveeuw Sarah, Romero Alvin, Hodsoll John, Gregory Alice M
Department of Psychiatry, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.
MRC Social, Genetic, and Developmental Psychiatry Centre, Institute of Psychiatry, Psychology, and Neuroscience, King's College London, London, UK.
BMJ Open. 2017 Dec 1;7(11):e017177. doi: 10.1136/bmjopen-2017-017177.
Cognitive-behavioural therapy for insomnia (CBT-I) leads to insomnia symptom improvements in a substantial proportion of patients. However, not everyone responds well to this treatment, and it is unclear what determines individual differences in response. The broader aim of this work is to examine to what extent response to CBT-I is due to genetic and environmental factors. The purpose of this pilot study is to examine feasibility of a design to test hypotheses focusing on an unselected sample, that is, without selection on insomnia complaints, in order to plan a larger behavioural genetics study where most participants will likely not have an insomnia disorder.
A two parallel-group randomised controlled trial is being conducted across three London universities. Female students (minimum age 18 years) enrolled on a psychology programme at one of the three sites were invited to participate. The target number of participants to be recruited is 240. Following baseline assessments, participants were randomly allocated to either the treatment group, where they received weekly sessions of digital CBT-I for 6 weeks, or the control group, where they completed an online puzzle each week for 6 weeks. Follow-up assessments have taken place mid-intervention (3 weeks) and end of intervention (6 weeks). A 6-month follow-up assessment will also occur. Primary outcomes will be assessed using descriptive statistics and effect size estimates for intervention effects. Secondary outcomes will be analysed using multivariate generalised estimating equation models.
The study received ethical approval from the Research Ethics and Integrity subcommittee, Goldsmiths, University of London (application reference: EA 1305). DNA sample collection for the BioResource received ethical approval from the NRES Committee South Central-Oxford (reference number: 15/SC/0388). The results of this work shall be published in peer-reviewed journals.
NCT03062891; Results.
失眠的认知行为疗法（CBT-I）可使相当一部分患者的失眠症状得到改善。然而，并非所有人对这种治疗的反应都良好，而且尚不清楚是什么决定了个体反应的差异。这项研究的更广泛目标是检验对CBT-I的反应在多大程度上归因于遗传和环境因素。这项初步研究的目的是检验一种设计的可行性，该设计旨在测试针对未经过选择的样本（即不根据失眠主诉进行选择）的假设，以便规划一项更大的行为遗传学研究，其中大多数参与者可能没有失眠症。
正在伦敦的三所大学进行一项双平行组随机对照试验。邀请了在这三个地点之一参加心理学课程的女学生（最低年龄18岁）参与。计划招募的参与者目标人数为240名。在进行基线评估后，参与者被随机分配到治疗组，在该组中他们接受为期6周的每周一次的数字CBT-I治疗，或者被分配到对照组，在该组中他们每周完成一个在线拼图游戏，为期6周。在干预中期（3周）和干预结束时（6周）进行了随访评估。还将进行6个月的随访评估。主要结局将使用描述性统计和干预效果的效应量估计进行评估。次要结局将使用多变量广义估计方程模型进行分析。
该研究获得了伦敦大学金史密斯学院研究伦理与诚信小组委员会的伦理批准（申请编号：EA 1305）。生物资源库的DNA样本采集获得了牛津中南部国家研究伦理服务委员会的伦理批准（参考编号：1/5C/0388）。这项研究的结果将发表在同行评审期刊上。
NCT03062891；结果
