School of Behavioural, Social and Legal Sciences, Örebro University Faculty of Humanities and Social Sciences, Örebro, Sweden
Department of Clinical Neuroscience, Karolinska Institute & Stockholm Health Care Services, Stockholm, Sweden.
BMJ Open. 2024 Oct 10;14(10):e086676. doi: 10.1136/bmjopen-2024-086676.
Paradoxical intention (PI) is an insomnia treatment developed in the 1970s, which instructs patients to gently attempt to remain awake while in bed at night with the lights off. Previous research indicates PI's potential in improving insomnia, although no study has been conducted in the last few decades during which the insomnia diagnostic criteria have changed. Additionally, there are knowledge gaps regarding outcomes related to wake after sleep onset, the treatment mechanisms as well as the acceptability and feasibility of the treatment. This study therefore aims to address these gaps by assessing the potential mechanisms, preliminary efficacy, and patient experience and acceptability of PI.
We aim to include 40 adult participants with insomnia, aged 18 and above, from the Swedish general population. In this uncontrolled pilot study using a mixed-methods approach, both qualitative and quantitative data will be collected. The trial will be conducted on a self-help online platform, accessible from participants' homes, with weekly phone call support by therapists. Process and outcome measures will be assessed weekly across a 4-week intervention period and at a 3-month follow-up. A subset of participants will be asked to participate in qualitative semistructured interviews regarding the treatment.
Ethical approval for this project has been granted by the Swedish Ethical Review Authority (Dnr: 2023-06594-01). All participants will sign informed consent forms on a web service application prior to enrolment. From this mixed-methods study, we anticipate insights into the preliminary efficacy and mechanisms of paradoxical intention for treating insomnia, enriched by patient experience data. Results will be disseminated through peer-reviewed publications. The findings will inform adaptations to the treatment protocol and serve as groundwork for a possible larger scale randomised controlled trial.
NCT06259682.
矛盾意向（PI）是一种 20 世纪 70 年代发展起来的失眠治疗方法，它指导患者在晚上关灯躺在床上时，轻轻尝试保持清醒。以前的研究表明 PI 在改善失眠方面具有潜力，尽管在过去几十年中，失眠的诊断标准已经发生了变化，没有研究进行过。此外，关于睡眠后觉醒相关的结果、治疗机制以及治疗的可接受性和可行性，还存在知识空白。因此，本研究旨在通过评估 PI 的潜在机制、初步疗效以及患者的体验和可接受性来填补这些空白。
我们的目标是纳入 40 名年龄在 18 岁及以上的瑞典普通人群中的失眠成年参与者。在这项使用混合方法的非对照试点研究中，将同时收集定性和定量数据。该试验将在一个自我帮助的在线平台上进行，参与者可以在家中访问该平台，并由治疗师每周通过电话提供支持。在 4 周的干预期间和 3 个月的随访中，每周评估过程和结果测量。将要求一部分参与者参加关于治疗的半结构化定性访谈。
该项目已获得瑞典伦理审查局的批准（编号：2023-06594-01）。所有参与者将在注册前通过网络服务应用程序签署知情同意书。从这项混合方法研究中，我们预计将深入了解矛盾意向治疗失眠的初步疗效和机制，并丰富患者的体验数据。结果将通过同行评审的出版物进行传播。研究结果将为治疗方案的调整提供信息，并为可能的更大规模随机对照试验奠定基础。
NCT06259682。
