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Efficacy of cognitive behavioural therapy for sleep improvement in patients with persistent delusions and hallucinations (BEST): a prospective, assessor-blind, randomised controlled pilot trial
Open accessAbstract
BACKGROUND: Sleep disturbance occurs in most patients with delusions or hallucinations and should be treated as a clinical problem in its own right. However, cognitive behavioural therapy (CBT)-the best evidence-based treatment for insomnia-has not been tested in this patient population. We aimed to pilot procedures for a randomised trial testing CBT for sleep problems in patients with current psychotic experiences, and to provide a preliminary assessment of potential benefit. METHODS: We did this prospective, assessor-blind, randomised controlled pilot trial (Better Sleep Trial [BEST]) at two mental health centres in the UK. Patients (aged 18-65 years) with persistent distressing delusions or hallucinations in the context of insomnia and a schizophrenia spectrum diagnosis were randomly assigned (1:1), via a web-based randomisation system with minimisation to balance for sex, insomnia severity, and psychotic experiences, to receive either eight sessions of CBT plus standard care (medication and contact with the local clinical team) or standard care alone. Research assessors were masked to group allocation. Assessment of outcome was done at weeks 0, 12 (post-treatment), and 24 (follow-up). The primary efficacy outcomes were insomnia assessed by the Insomnia Severity Index (ISI) and delusions and hallucinations assessed by the Psychotic Symptoms Rating Scale (PSYRATS) at week 12. We did analysis by intention to treat, with an aim to provide confidence interval estimation of treatment effects. This study is registered with ISRCTN, number 33695128. FINDINGS: Between Dec 14, 2012, and May 22, 2013, and Nov 7, 2013, and Aug 26, 2014, we randomly assigned 50 patients to receive CBT plus standard care (n=24) or standard care alone (n=26). The last assessments were completed on Feb 10, 2015. 48 (96%) patients provided follow-up data. 23 (96%) patients offered CBT took up the intervention. Compared with standard care, CBT led to reductions in insomnia in the large effect size range at week 12 (adjusted mean difference 6.1, 95% CI 3.0-9.2, effect size d=1.9). By week 12, nine (41%) of 22 patients receiving CBT and one (4%) of 25 patients receiving standard care alone no longer had insomnia, with ISI scores lower than the cutoff for insomnia. The treatment effect estimation for CBT covered a range from reducing but also increasing delusions (adjusted mean difference 0.3, 95% CI -2.0 to 2.6) and hallucinations (-1.9, -6.5 to 2.7). Three patients, all in the CBT group, had five adverse events, although none were regarded as related to study treatment. INTERPRETATION: Our findings show that CBT for insomnia might be highly effective for improving sleep in patients with persistent delusions or hallucinations. A larger, suitably powered phase 3 study is now needed to provide a precise estimate of the effects of CBT for sleep problems, both on sleep and psychotic experiences. FUNDING: Research for Patient Benefit Programme, National Institute for Health Research.
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“but the trial was underpowered to establish with sufficient precision the consequences for psychotic experiences.”
From The effects of improving sleep on mental health (OASIS): a randomised controlled trial with mediation analysis (2017) · cites this paper as [13]
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“A subsequent single-blind randomised controlled trial testing the efficacy of CBT for sleep problems in 50 patients with persistent delusions and hallucinations has been completed (Freeman & Waite et al., 2015). CBT was highly efficacious in improving insomnia in this population (Cohen's d effect size = 1.9), but was inconclusive about the impact of this treatment on psychotic experiences because”
From The role of sleep dysfunction in the occurrence of delusions and hallucinations: A systematic review (2015) · cites this paper as Freeman & Waite et al., 2015
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“since it is an important problem in its own right, for which effective treatments exist (Freeman & Waite et al., 2015).”
From The role of sleep dysfunction in the occurrence of delusions and hallucinations: A systematic review (2015) · cites this paper as Freeman & Waite et al., 2015
In the citing paper
“Serious adverse events were reported by Freeman et al. in patients with psychosis [44] and Sheaves et al. in psychiatric inpatients [45].The events were suicide attempts and violent incidents.All serious adverse events were considered unrelated to the study intervention.”
From Cognitive behavioral therapy for insomnia in patients with mental disorders and comorbid insomnia: A systematic review and meta-analysis (2022) · cites this paper as [44]
In the citing paper
“Sleep disorders have also been shown to be common and severe, but treatable, among individuals with psychotic disorders (Freeman et al., 2009, Freeman et al., 2015).”
From Sleep duration and psychotic experiences in patients at risk of psychosis: a secondary analysis of the EDIE-2 trial (2019) · cites this paper as Freeman et al., 2015
In the citing paper
“In patients with current delusions and hallucinations, results of our pilot randomised controlled trial13 have shown that insomnia can be substantially reduced with CBT”
From The effects of improving sleep on mental health (OASIS): a randomised controlled trial with mediation analysis (2017) · cites this paper as [13]
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“but was inconclusive about the impact of this treatment on psychotic experiences because of the sample size.”
From The role of sleep dysfunction in the occurrence of delusions and hallucinations: A systematic review (2015) · cites this paper as Freeman & Waite et al., 2015
In the citing paper
“Sleep dysfunction is treatable in clinical populations experiencing hallucinations.”
From Towards an Integrative Account of Potential Mechanisms Mediating the Path From Sleep Dysfunction to Hallucinations (2025) · cites this paper as [112]
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Metadata
- Authors
- Freeman, D., Waite, F., Startup, H., Myers, E., Lister, R., McInerney, J., Harvey, A. G., Geddes, J., Zaiwalla, Z., Luengo-Fernandez, R., Foster, R., Clifton, L., & Yu, L.-M.
- Affiliations
- Warneford Hospital (GB)
- Sussex Partnership NHS Foundation Trust (GB)
- University of California, Berkeley (US)
- John Radcliffe Hospital (GB)
- University of Oxford (GB)
- Corresponding author
- Freeman, Daniel
- ORCID
- Venue
- The Lancet Psychiatry
- Publisher
- Elsevier BV
- Published
- 2015-11
- Volume
- 2
- Issue
- 11
- Pages
- 975-983
- ISSN
- 2215-0366 (ISSN-L)
- PMC
- PMC4641164
- OpenAlex
- W2165478117
- Cited by
- 219
- References
- 52
- Citations by year
- 2026: 12 · 2025: 13 · 2024: 14 · 2023: 29 · 2022: 21 · 2021: 21 · 2020: 21 · 2019: 18 · 2018: 22 · 2017: 25 · 2016: 18 · 2015: 3
- FWCI
- 34.17
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Locations
- The Lancet Psychiatry (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- Funders
- National Health Service (NHS) National Institute for Health Research (NIHR) Research for Patient Benefit Programme (reference PB-PG-0211-10007)
- Wellcome Trust Strategic Award (098461/Z/12/Z)
- Topics
- Social Sciences › Psychology › Experimental and Cognitive Psychology › Sleep and related disorders
- Health Sciences › Medicine › Psychiatry and Mental health › Schizophrenia research and treatment
- Social Sciences › Psychology › Clinical Psychology › Psychological Treatments and Assessments
- Keywords
- cognitive behavioral therapy, insomnia, sleep disorders, delusions, hallucinations, psychotic experiences, schizophrenia spectrum disorders, psychosis, treatment efficacy, Insomnia Severity Index, treatment acceptability, medication adherence, adverse events
- MeSH terms
- Adult, Delusions, Double-Blind Method, Female, Hallucinations, Humans, Male, Middle Aged, Prospective Studies, Sleep Wake Disorders, Cognitive Behavioral Therapy, Treatment Outcome
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