Melatonin and Cognitive-Behaviour Therapy for the treatment of insomnia in individuals with schizophrenia

INTERVENTION: This clinical trial will be conducted to assess the relative or combined efficacy of Melatonin (Circadin), and Cognitive Behavioural Therapy for Insomnia in Schizophrenia: CBT‐I(S). There will be four experimental treatment conditions: Arm 1: CBT‐I(s) and placebo Arm 2: melatonin Arm 3: CBT‐I(S) and melatonin Arm 4: placebo Intervention details: Arm 1: CBT‐I(S) and Placebo: 4 weekly sessions of CBT‐I(S), and placebo capsules (corn starch) – daily use for 4 weeks. All CBT‐I(S) sessions will be administered to small groups of participants (4‐5) by a psychologist. CBT‐I(S) merges cognitive and behavioural therapies that address elements specifically found to maintain insomnia, such as poor sleep hygiene, dysfunctional beliefs and attitudes about sleep, rumination, and anxiety. Mainly education and discussion format. Total 4 sessions over 4 weeks (1 session a week for approx 2 hours). Arm 2: melatonin: Exogenous slow‐release melatonin (‘Circadin’) ‐ total 4 mg of melatonin (in capsule) per person daily for 4 weeks Arm 3: CBT‐I(S) and melatonin: 4 weekly sessions of CBT‐I(S), and daily use of exogenous melatonin capsules (Circadin) 4mg for 4 weeks. CBT‐I(S) session as described in Arm 1. Arm 4: placebo: Placebo capsules (corn starch) – daily use for 4 weeks Treatment instructions for both melatonin and placebo conditions will remain identical. Participants will be told to ingest a daily dose of melatonin, or placebo, after a light meal two hours prior to bedtime for 4 weeks. At Week 3, a face‐to‐face check‐up visit will be required for all participants to conduct a pill count and check treatment adherence. At the end of the trial, any unused medication (melatonin or placebo) will be returned to Graylands Hospital Pharmacy, alongside an accountability form, and disposed of in accordance with policies at Graylands Hospital Pharmacy for clinical trials. CONDITION: Insomnia Schizophrenia PRIMARY OUTCOME: Improvements in sleep ‐ as measured with actigraphy and sleep diaries Reduction in insomnia symptoms, based on Insomnia Severity Index SECONDARY OUTCOME: Improvements in clinical symptoms, assessed with Brief Psychiatric Rating Scale (BPRS) Improvements in cognitive performance on measures of attention (CPT‐IP, Letter Cancellation task), learning and memory (Rey Auditory Verbal Learning Task), processing speed (Symbol Digit Modality Test, Token Motor Task, Letter Cancellation task), motor performance (Finger Tapping task), and executive functions (Verbal Fluency, Number Generation Task; Trails Making Test) Improvements in functional health measured with the SF‐36 Health Survey Improvements in sleep hygiene practices and positive thinking, assessed with the Sleep Hygiene Index and Perseverative Thinking Questionnaire INCLUSION CRITERIA: 1. Aged 25 to 50 years. 2. A diagnosis of schizophrenia or schizoaffective disorder 3. Length of illness 10‐15 years 4. Currently in a clinically stable condition 5. Current insomnia symptoms, characterised by Sleep Onset Latency (SOL) more than 30 minutes, or waking up 3 or more times per night, with an ongoing duration of the sleep problem for at least one month. 6. Stable medication schedule and dosage for the past month 7. English as a first language 8. Using contraceptives (applicable to females only) 9. Confirmation of diagnosis and suitability for the study by the potential participant’s treating psychiatrist 10. Able to provide informed consent