TerminatedPhase 4ACTRN12613000970741

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

For individuals with schizophrenia and insomnia, can melatonin and CBT improve sleep, symptoms, functioning and cognitive functions

Sponsor

The University of Western Australia

Enrollment

64 participants

Start Date

Mar 4, 2014

Study Type

Interventional

Conditions

Insomnia Schizophrenia

Summary

The study is to evaluate the effectiveness of (i) Cognitive-behavioural therapy for insomnia in schizophrenia [CBT-I(S)] (ii) melatonin, (iii) a combination of CBT-I(S) and melatonin, and (iv) placebo, on insomnia symptoms, clinical symptoms, cognition, and functional health, in individuals with schizophrenia.

Eligibility

Sex: Both males and femalesMin Age: 25 YearssMax Age: 50 Yearss

Inclusion Criteria10

Aged 25 to 50 years.
A diagnosis of schizophrenia or schizoaffective disorder
Length of illness 10-15 years
Currently in a clinically stable condition
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.
Stable medication schedule and dosage for the past month
English as a first language
Using contraceptives (applicable to females only)
Confirmation of diagnosis and suitability for the study by the potential participant’s treating psychiatrist
Able to provide informed consent

Exclusion Criteria8

Diagnosis or high indication of sleep-related breathing disorder (e.g. obstructive sleep apnoea), narcolepsy, nightmare disorder, periodic limb movement syndrome, or restless legs syndrome.
Suicidality.
Allergy to melatonin, corn starch, gelatine
BMI >35 (clinical obesity).
Co-morbid significant medical conditions (e.g. seizure disorder, traumatic brain injury, dementia, autoimmune disease, liver failure, or kidney failure).
Known hereditary problem of galactose intolerance, the LAPP lactase deficiency, or glucose-galactose malabsorption.
Pervasive developmental disorder or mental retardation, as defined by DSM-IV or DSM-V criteria.
Pregnant or breastfeeding (applicable to females only).

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Interventions

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

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.