CBT-I with Melatonin for Older Adults with Chronic Insomnia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, double-blind study will compare three groups over four weeks: CBT-I with melatonin, CBT-I with placebo, and sleep-health psychoeducation with placebo. Participants will complete sleep diaries, questionnaires, actigraphy, and polysomnography to measure sleep, circadian rhythm, mood, fatigue, and cognitive function. Assessments occur at baseline, mid-treatment, post-treatment, and follow-ups at three and six months for the CBT-I groups. The study will recruit adults 60+ with DSM-5 insomnia disorder and ISI scores above 14, and will use 3 mg immediate-release melatonin or matched placebo taken 30 minutes before bedtime.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Chinese aged ≥ 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.

Where it's running

• Sleep Research Clinic and Laboratory, Department of Psychology, The University of Hong Kong
  Hong Kong, Hong Kong Recruiting

Study contacts

• Study coordinator: Shirley Xin LI, DClinPsy, PhD
• Email: shirleyx@hku.hk
• Phone: 852 39177035

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.