None listed
Conditions
Brief 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.
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 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 b
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.
Sponsors
The University of Western Australia
Study design
Allocation
Randomised controlled trial
Intervention model
Factorial
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
25 Years to 50 Years
Healthy volunteers
No
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
Exclusion criteria
1. 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. 2. Suicidality. 3. Allergy to melatonin, corn starch, gelatine 4. BMI >35 (clinical obesity). 5. Co-morbid significant medical conditions (e.g. seizure disorder, traumatic brain injury, dementia, autoimmune disease, liver failure, or kidney failure). 6. Known hereditary problem of galactose intolerance, the LAPP lactase deficiency, or glucose-galactose malabsorption. 7. Pervasive developmental disorder or mental retardation, as defined by DSM-IV or DSM-V criteria. 8. Pregnant or breastfeeding (applicable to females only).
Outcome results
None listed