Efficacy of CBT-I With Adjuvant Melatonin in Older Adults Chronic Insomnia (NCT07695246) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Efficacy of CBT-I With Adjuvant Melatonin in Older Adults Chronic Insomnia
Hong Kong183 participantsStarted 2026-08-01
Plain-language summary
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.
Who can participate
Age range
60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Chinese aged ≥ 60.
. Provision of written informed consent.
. 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).
. Having a score of \> 14 on the ISI, indicating clinical insomnia.
Exclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Insomnia Symptoms - Insomnia Severity Index
Timeframe: Baseline, Mid-session (Week 2 of the intervention), Post-Treatment (one-week after treatment conclusion) for all participants, and at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.
. Having a progressive medical condition directly related to the onset and course of insomnia (e.g., cancer, chronic pain).
. Undergoing treatment for diseases known to affect sleep (e.g., chemotherapy).
. Having an untreated sleep disorder that may disrupt sleep continuity and quality (e.g., sleep-disordered breathing) except for insomnia disorder and circadian sleep-wake phase disorder.
. Having mild to significant cognitive impairment, defined by having a score of \< 22 on MOCA.
. Concurrent and regular use of extraneous melatonin or melatonin agonist (e.g., ramelteon).
. Receiving concurrent psychological treatment for insomnia.
. 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).