ISRCTN33695128.

Trial name or title	The effects of using cognitive behavioural therapy to improve sleep for patients with delusions and hallucinations (the BEST study): study protocol for a randomised controlled trial
Methods	Allocation: randomised Blinding: assessor blinded Location: outpatient and inpatient clinical teams, UK Length of follow‐up: 6 months
Participants	Diagnosis: clinical diagnosis of schizophrenia, schizoaffective disorder, or delusional disorder N = 60 Sex: not reported Age: 18 ‐ 65 years Length of illness: not reported Inclusion criteria: a current delusion or hallucination that has persisted for at least three months; a score of at least 2 on the distress scale of the Psychotic Symptom Rating Scales (PSYRATS) for either a delusion or hallucination; a clinical diagnosis of schizophrenia, schizoaffective disorder, or delusional disorder (that is, diagnosis of non‐affective psychosis (F2) in the International Classification of Diseases and Diagnostic and Statistical Manual IV); sleep difficulties lasting one month or longer with an ISI score of 15 or above (that is, above subthreshold insomnia). Participants must be aged between 18 and 65, and, where changes in medication are being made, entry to the study would not occur until at least a month after stabilisation of dosage. It should be noted that we will be seeing participants. Exclusion criteria: a primary diagnosis of sleep apnoea, alcohol or substance dependency, an organic syndrome or learning disability, a command of spoken English inadequate for engaging in therapy; and current individual CBT
Interventions	1. CBT plus standard care group: N = 30 Content: 1) psychoeducation about sleep difficulties, assessment of the triggering and maintenance of sleep difficulties, and goal setting, 2) active therapeutic techniques that are used included sleep hygiene, stimulus control therapy, 3) relaxation, and, less often, cognitive techniques to address unhelpful beliefs and attitudes about sleep, attentional bias, monitoring, and safety behaviours. The intervention is deliberately simplified, with the principal therapeutic technique being stimulus control; that is, learning to associate bed with sleep. Delivered by: carried out by a qualified clinical psychologist Frequency: up to 8 sessions over 12 weeks; follow‐up at 6 months Treatment duration: 12 weeks 2. Standard care group: N = 30 Content: standard care delivered according to national and local service protocols and guidelines Delivered by: not reported Frequency: up to 8 sessions over 12 weeks; follow‐up at 6 months Treatment duration: 12 weeks
Outcomes	The Positive and Negative Symptom Scale Insomnia: ISI (Insomnia Severity Index) Hallucinations: PSYRATS The Beck Anxiety Inventory The Beck Depression Inventory Insomnia (self‐reported): the Pittsburgh Sleep Quality Index Quality of life: EQ‐5D‐5 levels Well‐being: the Warwick‐Edinburgh Mental Well‐being Scale The priorities, such as self‐confidence, peace of mind, and a sense of being in control: CHOICE Fatigue: Multidimensional Fatigue Inventory Suspicious thoughts: the Green Paranoid Thoughts Scale Service use including medication consumption (type, dose, and time taken), use of alcohol, illicit drugs, and nicotine, physical health history, adverse events, and hospital admission data (including use of the Client Service Receipt Inventory. A night‐time worry scale and an activity diary
Starting date	November 1, 2012
Contact information	Prof Daniel Freeman, University Department of Psychiatry Warneford Lane, Headington, City/town Oxford, Zip/Postcode OX3 7JX Country United Kingdom. Email Daniel.Freeman@psych.ox.ac.uk
Notes	*The term 'Treatment‐as‐usual (TAU)' was used in this paper.