Colagiuri Ben, Sharpe Louise, Ambarchi Zahava, Glozier Nick, Bartlett Delwyn, Costa Daniel S J, Scott Amelia
School of Psychology, The University of Sydney, Sydney, New South Wales, Australia
School of Psychology, The University of Sydney, Sydney, New South Wales, Australia.
BMJ Open. 2021 Feb 26;11(2):e044045. doi: 10.1136/bmjopen-2020-044045.
Insomnia is a prevalent sleep disorder that causes substantial personal and societal harm. There is evidence that placebo interventions can reduce insomnia symptoms, but this research has involved deceptively administering the placebo under the guise of a real medication (conventional placebo, CP), which has obvious ethical constraints. Open-label placebo (OLP) treatment, in which a placebo is administered with full disclosure that there are no active ingredients, has been proposed as a method of using the placebo effect ethically, but the efficacy and acceptability of OLP for insomnia is currently unknown.
This study uses a cohort multiple randomised controlled trial design to compare OLP, CP and no treatment for insomnia. Two-hundred and sixty-seven participants with self-reported insomnia symptoms (Insomnia Severity Index, ISI ≥10) will be recruited into an observational study and have their sleep monitored over a 2-week period. Participants will then be randomised to one of three groups: invite to OLP, invite to CP described deceptively as a new pharmacological agent, or no invite/observational control. Those in OLP and CP accepting the invite receive identical placebos for a 2-week treatment period while sleep is monitored in all participants. The primary outcome is ISI at the end of the treatment period. Secondary outcomes include treatment uptake and clinically significant response rates, objective and subjective sleep parameters, fatigue, mood, expectancy, treatment satisfaction and side effects. Predictors of uptake and responses to OLP and CP will be explored.
The trial has been approved by The University of Sydney Human Research Ethics Committee. Written informed consent is obtained from every participant. OLP and CP participants accepting the invite undergo an additional consent process. Results will be disseminated via peer-reviewed conference proceedings and publications.
ACTRN12620001080910.
失眠是一种常见的睡眠障碍，会对个人和社会造成重大危害。有证据表明，安慰剂干预可以减轻失眠症状，但此前的研究涉及在真实药物的伪装下欺骗性地给予安慰剂（传统安慰剂，CP），这存在明显的伦理限制。公开标签安慰剂（OLP）治疗，即给予安慰剂时完全告知其不含活性成分，已被提议作为一种符合伦理地利用安慰剂效应的方法，但目前尚不清楚OLP治疗失眠的疗效和可接受性。
本研究采用队列多重随机对照试验设计，比较OLP、CP和不治疗对失眠的效果。将招募267名自我报告有失眠症状（失眠严重程度指数，ISI≥10）的参与者进入一项观察性研究，并在2周内对他们的睡眠进行监测。然后，参与者将被随机分为三组之一：邀请接受OLP、邀请接受被欺骗性描述为新型药物的CP，或不邀请/观察对照。接受邀请的OLP组和CP组参与者在2周的治疗期内接受相同的安慰剂，同时对所有参与者的睡眠进行监测。主要结局是治疗期结束时的ISI。次要结局包括治疗接受率和临床显著反应率、客观和主观睡眠参数、疲劳、情绪、期望、治疗满意度和副作用。将探索OLP和CP的接受率及反应的预测因素。
该试验已获得悉尼大学人类研究伦理委员会的批准。每位参与者均获得书面知情同意书。接受邀请的OLP组和CP组参与者需经历额外的同意过程。研究结果将通过同行评审的会议论文集和出版物进行传播。
ACTRN12620001080910。
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