Sato Daisuke, Yoshinaga Naoki, Nagai Eiichi, Hanaoka Hideki, Sato Yasunori, Shimizu Eiji
Departments of Cognitive Behavioral Physiology, Chiba University Graduate School of Medicine, Chiba, Japan.
Department of Rehabilitation Sciences, Faculty of Health Care Sciences, Chiba Prefectural University of Health Sciences, Chiba, Japan.
BMJ Open. 2018 Jan 30;8(1):e018220. doi: 10.1136/bmjopen-2017-018220.
Insomnia has severe consequences for health. Primary care physicians in Japan commonly provide hypnotics, which is far from optimal. The recommended treatment for insomnia is cognitive-behavioural therapy (CBT). Access to trained therapists, however, is limited. Rather than face-to-face CBT, several researchers have studied internet-delivered computerised CBT (ICBT). This paper describes the study protocol for a randomised controlled trial (RCT) to evaluate effectiveness and feasibility of our newly developed five-step ICBT as an adjunct to usual care (UC) compared with UC alone for patients with insomnia who remain symptomatic following hypnotics.
This proposed exploratory RCT comprises two parallel groups (ICBT+UC and UC alone) consisting of 15 participants each (n=30) diagnosed with insomnia who remain symptomatic after pharmacotherapy. We aim to evaluate the effectiveness of six intervention weeks. The primary outcome of insomnia severity will be the Pittsburgh Sleep Quality Index (PSQI) at week 6. Secondary outcomes include sleep onset latency, total sleep time, sleep efficiency extracted from PSQI, current feeling of refreshment and perceived soundness of sleep measured using visual analogue scale, number of awakenings, anxiety by Hospital Anxiety and Depression Scale, depression by Center for Epidemiologic Studies Depression Scale and quality of life by Euro Qol-5D. All measures will be assessed at weeks 0 (baseline), 6 (postintervention) and 12 (follow-up), and intention-to-treat analysis will be applied. The statistical analysis plan has been developed considering design of field materials.
This study will be conducted at the academic outpatient clinic of Chiba University Hospital, Japan. Ethics approval was granted by the Institutional Review Board of Chiba University Hospital. All participants will be required to provide written informed consent. The trial will be implemented and reported in accordance with Consolidated Standards of Reporting Trials recommendations.
UMIN000021509; Pre-results.
失眠对健康有严重影响。日本的初级保健医生通常会开具催眠药，但这远非最佳治疗方法。失眠的推荐治疗方法是认知行为疗法（CBT）。然而，获得经过培训的治疗师的途径有限。与面对面的CBT不同，一些研究人员对通过互联网提供的计算机化CBT（ICBT）进行了研究。本文描述了一项随机对照试验（RCT）的研究方案，以评估我们新开发的五步ICBT作为常规护理（UC）辅助手段的有效性和可行性，并将其与仅接受UC治疗的失眠患者进行比较，这些患者在服用催眠药后仍有症状。
这项拟进行的探索性RCT包括两个平行组（ICBT+UC组和仅UC组），每组由15名被诊断为失眠且在药物治疗后仍有症状的参与者组成（n=30）。我们旨在评估六周干预的有效性。失眠严重程度的主要结局指标将是第6周的匹兹堡睡眠质量指数（PSQI）。次要结局指标包括入睡潜伏期、总睡眠时间、从PSQI中提取的睡眠效率、使用视觉模拟量表测量的当前恢复感和睡眠质量感知、觉醒次数、医院焦虑抑郁量表测量的焦虑、流行病学研究中心抑郁量表测量的抑郁以及欧洲五维健康量表测量的生活质量。所有测量指标将在第0周（基线）、第6周（干预后）和第12周（随访）进行评估，并将采用意向性分析。已根据现场材料的设计制定了统计分析计划。
本研究将在日本千叶大学医院的学术门诊进行。千叶大学医院机构审查委员会已批准伦理审查。所有参与者都将被要求提供书面知情同意书。该试验将按照《报告试验的统一标准》的建议进行实施和报告。
UMIN000021509；预结果。
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