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The effects of improving sleep on mental health (OASIS): a randomised controlled trial with mediation analysis

Open access
Freeman, Daniel, Sheaves, Bryony, Goodwin, Guy M, Yu, Ly-Mee, Nickless, Alecia, Harrison, Paul J, Emsley, Richard, Luik, Annemarie I +34 more·2017·The Lancet Psychiatry
DOI 10.1016/s2215-0366(17)30328-0PMC PMC5614772
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Abstract

BACKGROUND: Sleep difficulties might be a contributory causal factor in the occurrence of mental health problems. If this is true, improving sleep should benefit psychological health. We aimed to determine whether treating insomnia leads to a reduction in paranoia and hallucinations. METHODS: We did this single-blind, randomised controlled trial (OASIS) at 26 UK universities. University students with insomnia were randomly assigned (1:1) with simple randomisation to receive digital cognitive behavioural therapy (CBT) for insomnia or usual care, and the research team were masked to the treatment. Online assessments took place at weeks 0, 3, 10 (end of therapy), and 22. The primary outcome measures were for insomnia, paranoia, and hallucinatory experiences. We did intention-to-treat analyses. The trial is registered with the ISRCTN registry, number ISRCTN61272251. FINDINGS: Between March 5, 2015, and Feb 17, 2016, we randomly assigned 3755 participants to receive digital CBT for insomnia (n=1891) or usual practice (n=1864). Compared with usual practice, the sleep intervention at 10 weeks reduced insomnia (adjusted difference 4·78, 95% CI 4·29 to 5·26, Cohen's d=1·11; p<0·0001), paranoia (-2·22, -2·98 to -1·45, Cohen's d=0·19; p<0·0001), and hallucinations (-1·58, -1·98 to -1·18, Cohen's d=0·24; p<0·0001). Insomnia was a mediator of change in paranoia and hallucinations. No adverse events were reported. INTERPRETATION: To our knowledge, this is the largest randomised controlled trial of a psychological intervention for a mental health problem. It provides strong evidence that insomnia is a causal factor in the occurrence of psychotic experiences and other mental health problems. Whether the results generalise beyond a student population requires testing. The treatment of disrupted sleep might require a higher priority in mental health provision. FUNDING: Wellcome Trust.

AI snapshot

Written from the paper’s full text.

TL;DR

In the OASIS trial, digital CBT for insomnia in university students reduced insomnia and produced small sustained reductions in paranoia and hallucinations compared with usual practice. Mediation analyses suggested that improvements in insomnia accounted for a substantial portion of the reductions in psychotic experiences.

Key findings

  • Among 3755 randomised participants (digital CBT n=1891; usual practice n=1864), at 10 weeks the intervention reduced insomnia (adjusted difference 4·78, 95% CI 4·29–5·26, Cohen’s d=1·11), paranoia (−2·22, −2·98 to −1·45, d=0·19), and hallucinations (−1·58, −1·98 to −1·18, d=0·24); all p<0·0001.
  • Insomnia mediated change in psychotic experiences: week 3 insomnia explained 29·5% of the paranoia effect and 20·7% of the hallucination effect at week 10; week 10 insomnia explained 57·8% and 38·6%, respectively. Reverse-direction mediation was much smaller (paranoia 3·8%; hallucinations 3·4%).
  • Secondary outcomes improved for depression, anxiety, prodromal symptoms, nightmares, psychological wellbeing, and functioning, and participants were less likely to meet criteria for depressive episode, anxiety disorder, or ultra-high risk of psychosis. However, mania symptoms increased and risk of meeting criteria for a manic episode was greater; no adverse events were reported.

Methods

  • Single-blind, randomised controlled trial at 26 UK universities. Participants were university students aged 18 or older with a positive insomnia screen (SCI score ≤16) and no exclusion criteria; recruitment ran March 5, 2015, to Feb 17, 2016.
  • Participants were randomly assigned 1:1 via simple randomisation to digital CBT for insomnia (Sleepio) or usual practice, with online assessments at weeks 0, 3, 10, and 22. Primary outcomes were insomnia (SCI-8), paranoia (GPTS part B), and hallucinations (SPEQ hallucinations subscale).
  • Intention-to-treat analyses used linear mixed effects models with time, randomised group, baseline score, sex, and course level as fixed effects and random effects for students nested within universities. Mediation used a Baron-and-Kenny-like approach with linear mixed effects models.

Limitations

  • The paper states: reliance on self-report questionnaires; samples were predominantly in the non-clinical range of psychotic experiences; participants were self-selecting; generalisability beyond students is unknown; high dropout, especially in the treatment group, may bias results; and mediation cannot fully capture temporal order or rule out reverse causation.
  • The text also makes evident that treatment uptake was low: 69% logged on for at least one session and 18% accessed all six sessions, with treatment effects greater among completers.
  • The paper reports no adverse events, but also reports increased mania symptoms and greater risk of meeting manic episode criteria with the sleep treatment, which it discusses as possibly reflecting increased wellbeing or problematic manic symptoms.

Model-written summary. Check it against the paper before relying on it.

Integrity signals

Registry

Crossref · 10.1016/s2215-0366(17)30328-0

Cites

39 of 39 references verified0 citation errors · 0 not checkable

Statistics

Nothing to recompute.

Claims the paper makes

0 of 34 cited sources checked · 0 supported · 0 flagged

  • Findingown data

    Insomnia was a mediator of change in hallucinations.

    “Insomnia was a mediator of change in paranoia and hallucinations.”
    Quote in the paperSubstantial claim
  • Findingown data

    Insomnia was a mediator of change in paranoia.

    “Insomnia was a mediator of change in paranoia and hallucinations.”
    Quote in the paperSubstantial claim
  • Findingown data

    Compared with usual practice, the sleep intervention at 10 weeks reduced paranoia (−2.22, −2.98 to −1.45, Cohen's d=0.19; p<0.0001).

    “Compared with usual practice, the sleep intervention at 10 weeks reduced insomnia (adjusted difference 4·78, 95% CI 4·29 to 5·26, Cohen's d=1·11; p<0·0001), paranoia (−2·22, −2·98 to −1·45, Cohen's d=0·19; p<0·0001), and hallucinations (−1·58, −1·98 to −1·18, Cohen's d=0·24; p<0·0001).”
    Quote in the paperSubstantial claim
  • Findingown data

    Compared with usual practice, the sleep intervention at 10 weeks reduced hallucinations (−1.58, −1.98 to −1.18, Cohen's d=0.24; p<0.0001).

    “Compared with usual practice, the sleep intervention at 10 weeks reduced insomnia (adjusted difference 4·78, 95% CI 4·29 to 5·26, Cohen's d=1·11; p<0·0001), paranoia (−2·22, −2·98 to −1·45, Cohen's d=0·19; p<0·0001), and hallucinations (−1·58, −1·98 to −1·18, Cohen's d=0·24; p<0·0001).”
    Quote in the paperSubstantial claim
  • Findingown data

    No adverse events were reported.

    “No adverse events were reported.”
    Quote in the paperNot a substantial claim
  • May combine two claims. 16
  • Classified as probably not a substantial claim. 36

  • May combine two claims.

    Findingown data

    A PubMed search identified 130 papers, and only two were randomised controlled trials that tested the effects of sleep treatment on psychotic experiences, with the larger of the trials being the authors' own with 50 patients with schizophrenia or related disorders.

    “130 papers were identified and only two were randomised controlled trials that tested the effects of sleep treatment on psychotic experiences, with the larger of the trials being our own with 50 patients with schizophrenia or related disorders.”
    Quote in the paperSubstantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingown data

    The sample was predominately studying for their first university degree.

    “The sample was predominately female, studying for their first university degree, and two-thirds were of white British ethnicity (table 1).”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingown data

    Two-thirds of the sample were of white British ethnicity.

    “The sample was predominately female, studying for their first university degree, and two-thirds were of white British ethnicity (table 1).”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingown data

    Around a fifth of the participants were in contact with mental health services.

    “Around a fifth of the participants were in contact with mental health services (table 1).”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingown data

    The sample was predominately female.

    “The sample was predominately female, studying for their first university degree, and two-thirds were of white British ethnicity (table 1).”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Findingown data

    The improvements in depression, anxiety, prodromal symptoms, nightmares, psychological wellbeing, and functioning were maintained over time.

    “The sleep treatment also led to improvements in depression, and improvements in anxiety, prodromal symptoms, nightmares, psychological wellbeing, and functioning, and all these improvements were maintained over time (Table 4, Table 5).”
    Quote in the paperSubstantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductown data

    Sensitivity analyses (pattern mixture models, inclusion of baseline covariates predictive of missing data, and imputation) examined robustness of the three main outcomes to different missing-data assumptions.

    “We did sensitivity analyses (pattern mixture models, inclusion of baseline covariates predictive of missing data, and imputation) for the three main outcomes, examining the robustness of the results to different assumptions regarding missing data.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Premisecitation

    Clinical guidelines recommend CBT as the first-line treatment for insomnia.

    “Clinical guidelines recommend the use of cognitive behavioural therapy (CBT) as the first-line treatment for insomnia.9”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [9] Qaseem, 2016, Management of chronic insomnia disorder in adults: a clinical practice guideline from the American College of Physicians, Ann Intern Med source

      Not checked in the free run.

  • Classified as probably not a substantial claim.

    Premisecitation

    The effects of manipulation can be substantiated further by use of mediation analysis.

    “The effects of the manipulation can then be substantiated further by use of mediation analysis.5, 6”
    Quote in the paperSubstantial claim0 of 2 sources checked
    • cites [5] Dunn, 2015, Evaluation and validation of social and psychological markers in randomised trials of complex interventions in mental health: a methodological research programme, Health Technol Assess source

      Not checked in the free run.

    • cites [6] Emsley, 2010, Mediation and moderation of treatment effects in randomised controlled trials of complex interventions, Stat Methods Med Res source

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductnone given

    The trial is registered with the ISRCTN registry, number ISRCTN61272251.

    “The trial is registered with the ISRCTN registry, number ISRCTN61272251.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Study design and conductreasoning

    Participants completed all assessments independently online, so their responses could not be affected by the trial team.

    “Participants completed all the assessments independently online and therefore their responses could not be affected by the trial team.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductown data

    The internal consistency of the SPEQ hallucinations subscale in the present study was 0.93.

    “The internal consistency of the scale in the present study was 0·93.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Study design and conductown data

    The normality assumption of residuals was confirmed for each outcome, with no deviations from normality apparent.

    “We confirmed the normality assumption of the residuals for each outcome. No deviations from normality were apparent and therefore maximum likelihood estimates were reported.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductown data

    The sample size was increased in a study amendment because of a higher than initially expected dropout rate.

    “In a study amendment, the sample size was increased because of a higher than initially expected dropout rate.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Premisecitation

    Each psychotic experience exists on a spectrum of severity in the general population with differing heritability and differing strength of association with insomnia.

    “Each psychotic experience exists on a spectrum of severity in the general population with differing heritability and differing strength of association with insomnia.7”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [7] Taylor, 2015, Do sleep disturbances and psychotic experiences in adolescence share genetic and environmental influences?, J Abnorm Psychol source

      Not checked in the free run.

  • Classified as probably not a substantial claim.

    Premisecitation

    The interventionist-causal model approach to establishing a causal association is to manipulate the hypothesised mechanistic variable and observe the effect on the outcome of interest.

    “The interventionist–causal model approach to establishment of a causal association is to manipulate the hypothesised mechanistic variable and observe the effect on the outcome of interest;4”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [4] Kendler, 2009, Interventionist causal models in psychiatry: repositioning the mind-body problem, Psychol Med source

      Not checked in the free run.

  • Classified as probably not a substantial claim.

    Premisecitation

    If a causal association exists, then the outcome variable should alter when the hypothesised mechanistic variable is manipulated.

    “if a causal association exists then the outcome variable should alter.”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [4] Kendler, 2009, Interventionist causal models in psychiatry: repositioning the mind-body problem, Psychol Med source

      Not checked in the free run.

  • May combine two claims.

    Study design and conductcitation

    Randomisation was simple (1:1) with an automated online system, ensuring the research team was unable to affect randomisation.

    “As recommended for large clinical trials,17 we used simple randomisation (1:1) with an automated online system, ensuring that the research team was unable to affect randomisation.”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [17] Hewitt, 2006, Is restricted randomisation necessary?, Br Med J source

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductcitation

    A full statistical analysis plan was agreed before the trial analysis.

    “An outline of the analysis strategy was provided in the published trial protocol15 and a full statistical analysis plan was agreed before the trial analysis (appendix 2).”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [15] Freeman, 2015, Effects of cognitive behavioural therapy for insomnia on the mental health of university students, Trials source

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Study design and conductnone given

    Analyses were by intention to treat and carried out at the end of the last follow-up assessment with no interim analyses.

    “Analyses were by intention to treat and were carried out at the end of the last follow-up assessment (with no interim analyses).”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Premisecitation

    Digital forms of CBT for insomnia that require no therapist to be present have been shown to be efficacious.

    “Digital forms of CBT for insomnia that require no therapist to be present have been shown to be efficacious as well.10, 11, 12”
    Quote in the paperNot a substantial claim0 of 3 sources checked
    • cites [10] Ritterband, 2017, Effect of a web-based cognitive behaviour therapy for insomnia intervention with a 1-year follow-up: a randomized clinical trial, JAMA Psychiatry source

      Not checked in the free run.

    • cites [11] Espie, 2012, A randomized, placebo-controlled trial of online cognitive behavioral therapy for chronic insomnia disorder delivered via an automated media-rich web application, Sleep source

      Not checked in the free run.

    • cites [12] Christensen, 2016, Effectiveness of an online insomnia program (SHUTi) for prevention of depressive episodes (the GoodNight Study): a randomised controlled trial, Lancet Psychiatry source

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing), S4 (based).

    Interpretationnone given

    The trial is consistent with a small number of other randomised controlled trials that indicate multiple other benefits for mental health when treating sleep problems.

    “Furthermore, the trial is consistent with a small number of other randomised controlled trials that indicate multiple other benefits for mental health when treating sleep problems.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductown data

    The internal consistency (Cronbach's α at baseline) of the SCI in the present study was 0.63.

    “The internal consistency (Cronbach's α at baseline) of the scale in the present study was 0·63.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductown data

    The internal consistency of the GPTS in the present study was 0.94.

    “The internal consistency of the scale in the present study was 0·94.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductnone given

    All analyses were validated by a second statistician.

    “All the analyses were validated by a second statistician.”
    Quote in the paperNot a substantial claim

  • Classified as probably not a substantial claim.

    Premisereasoning

    The effect of altering the amount of sleep disruption on psychotic experiences remains to be established.

    “However, the effect of altering the amount of sleep disruption—eg, by targeted sleep treatment—on these psychotic experiences remains to be established.”
    Quote in the paperSubstantial claim

  • Classified as probably not a substantial claim. May combine two claims.

    Study design and conductcitation

    The SCI-8 is an 8-item measure validated against DSM-5 criteria, assessing sleep and its impact on daytime functioning over the past week.

    “This score is an 8-item measure, validated against DSM-5 criteria, assessing sleep and its impact on daytime functioning over the past week.”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [16] Espie, 2014, The sleep condition indicator: a clinical screening tool to evaluate insomnia disorder, BMJ Open source

      Not checked in the free run.

  • Classified as probably not a substantial claim.

    Premisecitation

    Disturbed sleep is a contributory causal factor in the occurrence of many mental health disorders.

    “An alternative perspective is that disturbed sleep is a contributory causal factor in the occurrence of many mental health disorders.1”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [1] Harvey, 2011, Sleep disturbance as transdiagnostic: consideration of neurobiological mechanisms, Clin Psychol Rev source

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductown data

    For secondary measures, ISI, PHQ-9, Altman Mania Scale, and WSAS scores were slightly higher in the missing groups than in the non-missing groups.

    “For the secondary measures, ISI, PHQ-9, Altman Mania Scale, and WSAS scores were slightly higher, and the WEMWBS score was slightly lower, in the missing groups than the non-missing groups (appendix 1).”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Interpretationnone given

    The participants were self-selecting in responding to the invitation, which will have affected the representativeness of the sample.

    “Third, the participants were self-selecting in responding to the invitation, which will have affected the representativeness of the sample.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductnone given

    No adverse events were reported to the trial team.

    “No adverse events were reported to the trial team.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductown data

    Participants who dropped out from both groups were more likely to be male than participants who remained in the study.

    “Compared with participants who remained in the study, participants who dropped out from both groups were younger in age and more likely to be male (appendix 1).”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Interpretationown data

    The trial indicates that the provision of internet-delivered CBT for insomnia to university students is likely to lead to reductions overall in insomnia, and smaller reductions in a number of other mental health symptoms, with benefits for positive psychological wellbeing too.

    “the trial does indicate that the provision of internet-delivered CBT for insomnia to university students is likely to lead to reductions overall in insomnia, and smaller reductions in a number of other mental health symptoms, with benefits for positive psychological wellbeing too.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Interpretationcitation

    The high rate of positive psychosis-risk screens at baseline reflects the well established associations of sleep difficulties with psychotic experiences and the limitations of brief self-report questionnaires for assessing psychosis risk.

    “this high rate will reflect the well established associations of sleep difficulties with psychotic experiences2, 3, 7, 8 (ie, that participants have been selected for insomnia and therefore will score higher on psychosis measures), and also the limitations of brief self-report questionnaires for assessing psychosis risk.”
    Quote in the paperNot a substantial claim0 of 3 sources checked
    • cites [2] Freeman, 2009, Insomnia and paranoia, Schizophr Res source

      Not checked in the free run.

    • cites [3] Reeve, 2015, The role of sleep dysfunction in the occurrence of delusions and hallucinations, Clin Psychol Rev source

      Not checked in the free run.

    • cites [7] Taylor, 2015, Do sleep disturbances and psychotic experiences in adolescence share genetic and environmental influences?, J Abnorm Psychol source

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductown data

    Participants who dropped out from both groups were younger in age than participants who remained in the study.

    “Compared with participants who remained in the study, participants who dropped out from both groups were younger in age and more likely to be male (appendix 1).”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Premisecitation

    The dropout figure and pattern were almost identical to the most comparable previous study.

    “with this figure and pattern almost identical to the most comparable previous study.12”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [12] Christensen, 2016, Effectiveness of an online insomnia program (SHUTi) for prevention of depressive episodes (the GoodNight Study): a randomised controlled trial, Lancet Psychiatry source

      Not checked in the free run.

  • May combine two claims.

    Interpretationnone given

    The samples tested were predominately in the non-clinical range of psychotic experiences, restricting the conclusions to the less severe end of the psychosis spectrum.

    “Second, the samples tested were predominately in the non-clinical range of psychotic experiences, restricting the conclusions to the less severe end of the psychosis spectrum.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductnone given

    The study relied on self-report questionnaires, albeit validated in their development against clinical interviews.

    “First, the study relied on self-report questionnaires, albeit validated in their development against clinical interviews.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Premisecitation

    The Altman scale has been found to correlate poorly with self-ratings of elation.

    “The Altman scale has been found to correlate poorly with self-ratings of elation.35”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [35] Tsanas, 2016, Daily longitudinal self-monitoring of mood variability in bipolar disorder and borderline personality disorder, J Affect Disord source

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Interpretationnone given

    The extent to which the results will generalise to the rest of the population is not known.

    “Fourth, the extent to which the results will generalise to the rest of the population is not known.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductown data

    For secondary measures, the WEMWBS score was slightly lower in the missing groups than in the non-missing groups.

    “For the secondary measures, ISI, PHQ-9, Altman Mania Scale, and WSAS scores were slightly higher, and the WEMWBS score was slightly lower, in the missing groups than the non-missing groups (appendix 1).”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Study design and conductown data

    In the intervention group, 1302 participants (69%) logged on for at least one treatment session, 953 (50%) accessed at least two sessions, 672 (36%) accessed at least three sessions, 497 (26%) accessed at least four sessions, 390 (21%) accessed at least five sessions, and 331 (18%) accessed six sessions.

    “In the intervention group, 1302 participants (69%) logged on for at least one treatment session, 953 (50%) accessed at least two sessions, 672 (36%) accessed at least three sessions, 497 (26%) accessed at least four sessions, 390 (21%) accessed at least five sessions, and 331 (18%) accessed six sessions (figure).”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Interpretationreasoning

    Insomnia might not be the largest cause of psychotic experiences but it is not an epiphenomenon.

    “Insomnia might not be the largest cause of psychotic experiences but it is not an epiphenomenon.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Study design and conductreasoning

    The mediation analyses in this trial based on week 10 outcomes cannot fully capture the temporal order of changes or rule out reverse causation.

    “but the mediation analyses in this trial based on week 10 outcomes cannot fully capture the temporal order of changes or rule out reverse causation.”
    Quote in the paperSubstantial claim

  • Probably not a substantial claim: may not pass S2 (checkable). May combine two claims.

    Interpretationreasoning

    Overall, this trial indicates the importance of sleep difficulties for mental health in the general population and the need for a reconsideration in clinical services of the priority given to improving sleep.

    “Overall, this trial indicates the importance of sleep difficulties for mental health in the general population and the need for a reconsideration in clinical services of the priority given to improving sleep.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S2 (checkable).

    Interpretationreasoning

    In reality, it is difficult in a clinical trial to capture potential temporal changes between mediator and outcomes, since improvements in paranoia and hallucinations are likely to closely parallel the improvement in sleep.

    “In reality, it is difficult in a clinical trial to capture potential temporal changes between mediator and outcomes, since improvements in paranoia and hallucinations are likely to closely parallel the improvement in sleep.”
    Quote in the paperNot a substantial claim
46 of 46

  • The paper relies on this without support.

    Usual practice is likely to mean receiving little or no treatment.

    “usual care, which is likely to mean receiving little or no treatment”
    “The amount of treatment input was likely to be minimal, with prescription of medication for a small proportion.”

  • The authors state this as an assumption.

    The data are missing at random.

    “The method has the advantage of implicitly accounting for data missing at random.”

  • The paper relies on this without support.

    There are multiple, independent psychotic experiences.

    “There are multiple, independent, psychotic experiences.”

  • The authors state this as an assumption.

    The sleep treatment first changes the occurrence of insomnia.

    “the causal argument rests on the plausible assumption that the sleep treatment first changes the occurrence of insomnia, since that was the topic of the intervention”

  • The paper relies on this without support.

    A gap exists in mental health services regarding intervention for early, relatively non-specific presentations.

    “a gap exists in mental health services regarding intervention for early, relatively non-specific presentations”

  • The paper relies on this without support.

    Young people with incipient disorders might be very reluctant to seek help for psychiatric problems.

    “Young people with incipient disorders might be very reluctant to seek help for psychiatric problems.”

  • The paper relies on this without support.

    Trouble sleeping is a common complaint with little stigma.

    “Trouble sleeping is a common complaint with little stigma.”
7 of 7

Claims other papers make about this one

Each is checked against this paper’s own text: does it say what the citing paper says it does?

Self-check

Percentages, sums and reported differences re-computed from the paper’s own numbers.

Each contradiction between two passages listed here was confirmed by an independent check.

  • Paranoia direct-effect confidence interval conflicts with its p value

    Minor

    The reported 95% confidence interval for the week 3 insomnia-mediated paranoia direct effect includes zero, while its associated two-sided p value is reported as less than 0·0001.

1 of 1

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Authors
Freeman, D., Sheaves, B., Goodwin, G. M., Yu, L.-M., Nickless, A., Harrison, P. J., Emsley, R., Luik, A. I., Foster, R. G., Wadekar, V., Hinds, C., Gumley, A., Jones, R., Lightman, S., Jones, S., Bentall, R., Kinderman, P., Rowse, G., Brugha, T., Blagrove, M., Gregory, A. M., Fleming, L., Walklet, E., Glazebrook, C., Davies, E. B., Hollis, C., Haddock, G., John, B., Coulson, M., Fowler, D., Pugh, K., Cape, J., Moseley, P., Brown, G., Hughes, C., Obonsawin, M., Coker, S., Watkins, E., Schwannauer, M., MacMahon, K., Siriwardena, A. N., & Espie, C. A.
Affiliations
  • National Health Service (GB)
  • University of Oxford (GB)
  • Manchester Academic Health Science Centre (GB)
  • Warneford Hospital (GB)
  • Gartnavel General Hospital (GB)
  • University of Plymouth (GB)
  • University of Bristol (GB)
  • University of Sheffield (GB)
  • University of Liverpool (GB)
  • University of Leicester (GB)
  • Swansea University (GB)
  • Goldsmiths University of London (GB)
  • University of Strathclyde (GB)
  • University of Worcester (GB)
  • University of Nottingham (GB)
  • University of Manchester (GB)
  • University of South Wales (GB)
  • Middlesex University London (GB)
  • University of Sussex (GB)
  • Sussex Partnership NHS Foundation Trust (GB)
  • University College London (GB)
  • University of Lancashire (GB)
  • Royal Holloway University of London (GB)
  • University of Cambridge (GB)
  • University of Exeter (GB)
  • University of Edinburgh (GB)
  • University of Lincoln (GB)
Corresponding author
Freeman, Daniel
ORCID
Venue
The Lancet Psychiatry
Publisher
Elsevier BV
Published
2017-10
Volume
4
Issue
10
Pages
749-758
ISSN
2215-0366 (ISSN-L)
DOI
10.1016/s2215-0366(17)30328-0
PMC
PMC5614772
OpenAlex
W2753665614
Semantic Scholar
797208a87ff04f1f341f2798f7ab7f8db93086ba
Cited by
652
References
38
Citations by year
2026: 53 · 2025: 68 · 2024: 73 · 2023: 80 · 2022: 83 · 2021: 98 · 2020: 83 · 2019: 55 · 2018: 46 · 2017: 11 · 2016: 1 · 2012: 1
FWCI
69.44
Type
journal article
Language
en
Open access
Licence
Locations
  • The Lancet Psychiatry (publishedVersion, cc-by)
  • Europe PMC (PubMed Central) (publishedVersion, cc-by)
  • PubMed Central (publishedVersion, cc-by)
  • PubMed (publishedVersion)
  • Open Research Exeter (University of Exeter) (publishedVersion, cc-by)
  • CLOK (University of Central Lancashire) (acceptedVersion)
  • ENLIGHTEN (Jurnal Bimbingan dan Konseling Islam) (acceptedVersion)
  • Research Repository (University of Gloucestershire) (acceptedVersion)
  • Goldsmiths (University of London) (acceptedVersion)
  • Lincoln Repository (University of Lincoln) (acceptedVersion)
  • White Rose Research Online (University of Leeds, The University of Sheffield, University of York) (acceptedVersion)
  • Northumbria Research Link (Northumbria University) (acceptedVersion)
  • Strathprints: The University of Strathclyde institutional repository (University of Strathclyde) (acceptedVersion)
  • UEA Digital Repository (University of East Anglia) (acceptedVersion)
  • Leicester Research Archive (University of Leicester) (acceptedVersion, other-oa)
  • Research Repository (University of Gloucestershire) (submittedVersion, other-oa)
  • Explore Bristol Research (submittedVersion, cc-by)
  • Sussex Research Online (University of Sussex) (submittedVersion, cc-by)
  • Worcester Research and Publications (University of Worcester) (submittedVersion)
  • Lancaster EPrints (Lancaster University) (submittedVersion)
  • Figshare (submittedVersion, cc-by)
  • Figshare (submittedVersion)
  • Research Portal (King's College London) (submittedVersion, cc-by)
  • PEARL (University of Plymouth) (submittedVersion)
  • Research Explorer (The University of Manchester) (submittedVersion, cc-by)
  • Edinburgh Research Explorer (University of Edinburgh) (submittedVersion, cc-by)
  • Bristol Research (University of Bristol) (submittedVersion, cc-by)
Funders
  • Wellcome Trust (098461/Z/12/Z)
  • National Institute for Health and Care Research (RP-2014-05-003, NF-SI-0514-10119)
  • University of Oxford
Topics
  • Social Sciences › Psychology › Experimental and Cognitive Psychology › Sleep and related disorders
  • Social Sciences › Psychology › Applied Psychology › Digital Mental Health Interventions
  • Social Sciences › Psychology › Clinical Psychology › COVID-19 and Mental Health
Keywords
insomnia, cognitive behavioral therapy for insomnia, paranoia, hallucinations, psychotic experiences, sleep disruption, university students, mental health, mediation analysis, digital psychological interventions
MeSH terms
Adolescent, Adult, Female, United Kingdom, Hallucinations, Humans, Sleep Initiation and Maintenance Disorders, Male, Mental Health, Paranoid Disorders, Sleep, Students, Cognitive Behavioral Therapy, Treatment Outcome, Young Adult

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Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.

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