Department of Psychiatry, University of Oxford, Oxford, UK
Oxford Health NHS Foundation Trust, Oxford, Oxfordshire, UK.
BMJ Open. 2020 Nov 10;10(11):e045235. doi: 10.1136/bmjopen-2020-045235.
Effective interventions, targeting key contributory causal factors, are needed to prevent the emergence of severe mental health problems in young people. Insomnia is a common clinical issue that is problematic in its own right but that also leads to the development and persistence of psychotic experiences. The implication is that treating sleep problems may prevent the onset of psychosis. We collected initial case series data with 12 young people at ultra-high-risk of psychosis. Post-intervention, there were improvements in sleep, depression and psychotic experiences. Now we test the feasibility of a randomised controlled trial, with a clinical aim to treat sleep problems and hence reduce depression, psychotic experiences, and prevent transition to psychosis.
A randomised controlled feasibility trial will be conducted. Forty patients aged 14 to 25 years who are at ultra-high-risk of psychosis and have sleep disturbance will be recruited from National Health Service (NHS) mental health services. Participants will be randomised to receive either a novel, targeted, youth-focussed sleep intervention in addition to usual care or usual care alone. Assessor-blinded assessments will be conducted at baseline, 3 months (post-intervention) and 9 months (follow-up). The eight-session psychological intervention will target the key mechanisms which disrupt sleep: circadian rhythm irregularities, low sleep pressure, and hyperarousal. To gain an in-depth understanding of participants' views on the acceptability of the intervention and study procedures, 16 participants (n=10 intervention, n=6 control) will take part in qualitative interviews. Analyses will focus on feasibility outcomes (recruitment, retention, and treatment uptake rates) and provide initial CI estimates of intervention effects. Thematic analysis of the qualitative interviews will assess the acceptability of the intervention and trial procedures.
The trial has received ethical approval from the NHS Health Research Authority. Findings will be disseminated through peer-reviewed publications, conference presentations, and lay networks.
ISRCTN85601537.
需要有效的干预措施来针对关键促成因素，以预防年轻人出现严重的心理健康问题。失眠是一种常见的临床问题，本身就存在问题，但也会导致精神病性体验的发展和持续。这意味着治疗睡眠问题可能会预防精神病的发作。我们对 12 名处于精神病超高风险的年轻人进行了初步的病例系列数据收集。干预后，睡眠、抑郁和精神病性体验都有所改善。现在我们正在测试一项随机对照试验的可行性，临床目标是治疗睡眠问题，从而减少抑郁、精神病性体验，并预防向精神病的转变。
将进行一项随机对照可行性试验。从国家卫生服务（NHS）心理健康服务中招募 40 名年龄在 14 岁至 25 岁之间、处于精神病超高风险且有睡眠障碍的患者。参与者将被随机分配接受一种新的、有针对性的、以年轻人为重点的睡眠干预措施，同时接受常规护理或单独接受常规护理。评估员盲法评估将在基线、3 个月（干预后）和 9 个月（随访）进行。八节心理干预将针对扰乱睡眠的关键机制：昼夜节律不规律、睡眠压力低和过度觉醒。为了深入了解参与者对干预措施和研究程序的可接受性的看法，将有 16 名参与者（n=10 名干预组，n=6 名对照组）参加定性访谈。分析将重点关注可行性结果（招募、保留和治疗参与率），并提供干预效果的初步置信区间估计。定性访谈的主题分析将评估干预措施和试验程序的可接受性。
该试验已获得英国国家卫生研究院伦理审查委员会的批准。研究结果将通过同行评议的出版物、会议演讲和非专业网络进行传播。
ISRCTN85601537。
