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

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.

NCT Number	NCT07695246
Lead Sponsor	The University of Hong Kong Collaborators: Chinese University of Hong Kong
Conditions	Insomnia, Aging, Sleep Disorders
Enrollment	183 participants
Start Date	2026-08-01
Primary Completion	2029-08-01 (estimated)
Study Completion	2029-08-01 (estimated)
Updated on ClinicalTrials.gov	2026-07-10