Treating sleep problems in young people at ultra-high-risk of psychosis: study protocol for a single-blind parallel group randomised controlled feasibility trial (SleepWell)

Abstract

BackgroundEffective 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.Methods and analysisA 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.Ethics and disseminationThe trial has received ethical approval from the NHS Health Research Authority. Findings will be disseminated through peer-reviewed publications, conference presentations, and lay networks.Trial registration numberISRCTN85601537.

Sleep Disturbance in Individuals at Clinical High Risk for Psychosis

“…58 Adjacent research has found that sleep quality is malleable and thus can be improved even in clinical populations. 59,60 These findings offer promising evidence for advancement in clinical staging models 61 and future sleep-related therapies for both CHR and overt psychosis, such as an upcoming trial by Waite et al 62 Another budding direction of research involves computational advances in causal discovery analysis, offering innovative approaches to addressing causality in the context of observational data. 63,64 Such methods require careful consideration of assumptions and properties underlying the data at hand, 65 but could be utilized in future analyses of these and other prospective longitudinal datasets involving CHR and other clinical populations.…”

A Systematic Review of the Reporting Quality of Observational Studies That Use Mediation Analyses

“…For example, Huang et al (2016) conducted a mediation analysis of an observational cohort and found that personality traits affected mental health partly through its effect (indirect effect) on sleep quality. This study informed the design of preventive programs to improve mental health through targeting sleep quality in randomised controlled trials (Freeman et al, 2017;Waite et al, 2020). Others have investigated the role of peer influence on the effect of drug exposure on drug use (Rudolph et al, 2018;Studer et al, 2014).…”

The nature, consequences, mechanisms, and management of sleep disturbances in individuals at-risk for psychosis

“…. in a randomized trial in young patients at ultra-high-risk of psychosis [for further details, see the published protocol (89)].…”

“…Other sleep interventions have been specifically designed and tested for use in young UHR people, such as the brief psychological intervention “SleepWell” that targets key sleep parameters (i.e., hyperarousal, sleep pressure, and circadian rhythm), and has yielded promising preliminary results ( 82 ). The SleepWell is now being tested in a randomized trial in young patients at ultra-high-risk of psychosis [for further details, see the published protocol ( 89 )].…”