N
← Back to Search
Sponsored

Accelerate Your Clinical Trial Recruitment

Reach thousands of high-intent patients matching your specific inclusion criteria.

Start Campaign
RECRUITING Not applicable ClinicalTrials.gov

Efficacy of CBT-I With Adjuvant Melatonin in Older Adults Chronic Insomnia

Sponsor: The University of Hong Kong • ClinicalTrials.gov ID: NCT07695246

Registry updated: 2026-08-21
Ad

Recruiting for Similar Conditions?

Sponsors are looking for patients like you. See if you qualify for compensated research studies.

Check Eligibility →

Description

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.

Interventions

  • Cognitive behavioural therapy for insomnia (Behavioral)
    CBT-I is a multi-component, non-pharmacologic intervention that targets behavioural, cognitive, and physiological perpetuating factors of insomnia. Four group-based weekly sessions (120-min; 6-8 participants) will be delivered. Components: sleep psychoeducation, sleep hygiene, stimulus control, sleep restriction, relaxation training, cognitive restructuring (addressing dysfunctional beliefs about sleep), and relapse prevention. Delivered in-person by trained therapists supervised weekly by the PI.
  • Melatonin 3 mg immediate-release (Dietary supplement)
    Melatonin is a safe and accessible sleep-promoting supplement. The tablet will be taken once daily, 30 minutes before habitual bedtime for 4 weeks, concurrent with CBT-I.
  • Psychoeducation (Behavioral)
    Four group-based weekly sessions covering sleep hygiene, healthy diet, and exercise habits for older adults. This arm will not include any active therapeutic CBT-I components. It serves as the active control, controlling for attention and non-specific expectancy effects.
  • Placebo Oral Tablet (Drug)
    Placebo capsule identical in appearance to the melatonin capsule, taken once daily, 30 minutes before habitual bedtime for 4 weeks. Used in CBT-I + Placebo and Psychoeducation + Placebo arms.

Eligibility criteria

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.

Conditions

Insomnia Aging Sleep Disorders

Locations

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

Partner with Nurenyx

Showcase your study to thousands of motivated patients matching your criteria.

Learn More

Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record