Randomised Study of Web-based CBT Intervention (Sleepio) to Reduce Insomnia and Improve Social Recovery in Early Psychosis (CRISP)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Change from baseline Work and Social Adjustment Scale (WSAS) score at week 9 of study
研究概览
简要总结
Sleep disturbances and cognitive dysfunction are consistently reported as extremely troublesome aspects of psychotic illnesses. While sleep disturbances are not included in definitions of psychosis they are associated with poor levels of daily function and impaired social recovery. Despite sleep problems being documented as co-occurring with psychosis, sleep remains unexamined as a potential therapeutic target pathway for social recovery. Specific areas of cognition are known to be associated with psychosis, sleep deficits and daily function, yet these have not been tested as possible mediators of the association between improved sleep and better daily function and social recovery.
This study will examine the relationship between sleep quality, daily function and ultimately social recovery in early psychosis. A secondary aim will examine whether specified areas of cognition (i.e. attention, memory, executive function, social and emotional recognition) mediate the proposed association between sleep and social recovery. Participants will have experienced a first episode psychosis and be currently engaged with CAMEO early intervention, in Cambridgeshire and Peterborough NHS Foundation Trust (CPFT) or Early Intervention in Psychosis Services (EIS), in Norfolk and Suffolk NHS Foundation Trust (NSFT). Cameo CPFT and Early Intervention in Psychosis Services NSFT are services for people aged 14-65 years old who are experiencing symptoms of psychosis for the first time (http://www.cameo.nhs.uk and https://www.nsft.nhs.uk/adults/service/early-intervention-in-psychosis-services-norfolk-and-waveney-103/). A publicly available, online intervention based on cognitive behavioural therapy (CBT) for insomnia (Sleepio) will be utilised to improve sleep. Participants will be randomised to receive the intervention + treatment as usual (TAU) through their early intervention team or TAU alone over an eight-week period. The entire study will last for seventeen weeks including an eight-week follow-up period.
详细描述
The study will take place in three stages; an initial survey, an eight week study period and a follow-up period for an additional eight weeks.
Stage One: Perceptions of Sleep Problems and Their Treatment in Psychosis:
Clinicians and service users will receive an online link to a short 18-question survey (primarily multiple choice) that should take approximately 5 min to complete. Although they can complete this online, a paper copy can be provided if they prefer to handwrite their answers.
Stage Two: Randomised 8 Week Study:
At our initial phone or NHS approved video platform meeting participants will be invited to ask any questions they have. If they choose to participate in our study, they will be asked to read and sign a consent form virtually or through the post. They will also be asked their preferred method of contact during the study so that the primary researcher can arrange appointments and check in once or twice per week. This will allow them to ask any questions which may arise and offer assistance if they are having any challenges with logging in or participation. They will also be informed that they have the right to withdraw from the study at any point and this will have no affect on their ongoing treatment through the EIS they are currently supported by.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Experiencing or having experienced a First Episode of Psychosis (FEP) within the past 5 years.
- •Currently participating in CPFT CAMEO EIPS or NSFT EIS and intending to continue TAU with the specified service for at least the next 4 months.
- •Mental capacity for consent.
- •Currently experiencing threshold level (score ≤ 16 on SCI-8) of disrupted sleep.
- •Adults 18 years or older.
- •Ability to understand and follow therapeutic instructions necessary for experiment and respond to online questionnaires.
- •Illness duration less than or equal to 5 years. Onset of illness was defined as first contact with psychiatric services for psychotic symptoms.
- •Access to the internet.
排除标准
- •Too unwell to viably participate in study.
- •A diagnosis of drug induced psychosis or bipolar disorder.
- •Psychotic disorder due to a medical or physical disease (i.e. considered to have an organic basis).
- •Current drug or alcohol dependency.
- •Currently taking prescribed sleep medication or intending to do so during study.
- •Currently doing night shift work.
- •Travel over 2 time zones during or within two weeks prior to assessment period.
结局指标
主要结局
Change from baseline Work and Social Adjustment Scale (WSAS) score at week 9 of study
时间窗: Measure completed at baseline (start of week 1) and week 9.
WSAS is a simple and reliable measure of impaired functioning. Scores range from 0-40, with lower scores representing better functioning, scores 0-10 are considered subclinical, 11-20 associated with significant functional impairment but less severe clinical symptomology, and \>20 suggest moderately severe functional impairment (Mundt et al. 2002).
次要结局
- Time Use Survey - Structured Hours (TUS-SH)(Measure completed in weeks 1, 5, 9, 13 and 17.)
- Spatial Working Memory (SWM) / CANTAB Cognitive Test(Measure completed in weeks 1, 5, 9, 13 and 17.)
- Patient Health Questionnaire (PHQ-9)(Measure completed in weeks 1, 5, 9, 13 and 17.)
- Global Assessment of Functioning (GAF) (split version / subscales GAF-D & GAF-S)(Measure completed in weeks 1, 9 and 17.)
- Rapid Visual Information Processing (RVP) / CANTAB Cognitive Test(Measure completed in weeks 1, 5, 9, 13 and 17.)
- Paired Associates Learning (PAL) / CANTAB Cognitive Test(Measure completed in weeks 1, 5, 9, 13 and 17.)
- Change from baseline Work and Social Adjustment Scale (WSAS) score at week 5, to correct for confounding in mediation analysis(Measure completed at baseline (start of week 1) and week 5.)
- Change from baseline Work and Social Adjustment Scale (WSAS) score at week 13, to correct for confounding in mediation analysis(Measure completed at baseline (start of week 1) and week 13.)
- Emotion Recognition Task (ERT) / CANTAB Cognitive Test(Measure completed in weeks 1, 5, 9, 13 and 17.)
- Change from baseline Work and Social Adjustment Scale (WSAS) score at week 17(Measure completed at baseline (start of week 1) and week 17.)
研究者
Peter Jones
Professor of Psychiatry / Deputy Head of Clinical School
University of Cambridge