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โ† Trials
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Efficacy of CBT-I With Adjuvant Melatonin in Older Adults Chronic Insomnia

RecruitingNAAges 60 Years - anyAllThe University of Hong Kong
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In plain words

What the trial is, and whether it could suit you

This study tests the efficacy of cognitive behavioural therapy for insomnia (CBT-I) with or without adjunct melatonin in older adults with insomnia. Adults aged 60 or above with chronic insomnia will be randomly assigned to one of three groups: (1) CBT-I plus nightly melatonin, (2) CBT-I plus nightly placebo tablet, or (3) sleep health psychoeducation plus nightly placebo tablet. All group sessions occur weekly for four weeks.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Chinese aged โ‰ฅ 60. 2. Provision of written informed consent. 3. Having a DSM-5 diagnosis of insomnia disorder (i.e., having difficulty initiating sleep, maintaining sleep, or early morning awakening at least three times a week for at least three months, with clinically significant impairment or distress). 4. Having a score of \> 14 on the ISI, indicating clinical insomnia. Exclusion Criteria: 1. Having a current diagnosis or a history of manic or hypomanic episodes, schizophrenia spectrum disorders, neurodevelopmental disorders, neurocognitive disorders, organic mental disorders, intellectual disabilities, or substance abuse or dependence. 2. Having a progressive medical condition directly related to the onset and course of insomnia (e.g., cancer, chronic pain). 3. Undergoing treatment for diseases known to affect sleep (e.g., chemotherapy). 4. Having an untreated sleep disorder that may disrupt sleep continuity and quality (e.g., sleep-disordered breathing) except for insomnia disorder. 5. Having mild to significant cognitive impairment, defined by having a score of \< 22 on MOCA. 6. Concurrent and regular use of extraneous melatonin or melatonin agonist (e.g., ramelteon). 7. Receiving concurrent psychological treatment for insomnia. 8. Meeting potential contraindications for melatonin (e.g., undergoing dialysis) or concurrently using medications that have a potential drug interaction with melatonin (e.g., anticoagulant and anti-platelet). 9. Being a night shift worker.
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What it tests

  • Cognitive behavioural therapy for insomnia
  • Melatonin 3 mg immediate-release
  • Psychoeducation
  • Placebo Oral Tablet
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Where

1 site
Sleep Research Clinic and Laboratory, Department of Psychology, The University of Hong Kong
Hong Kong, Hong Kong
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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