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NOT YET RECRUITING
NCT07695246
NA

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

Sponsor: The University of Hong Kong

View on ClinicalTrials.gov

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.

Official title: Efficacy of Cognitive Behavioural Therapy for Insomnia With Adjuvant Melatonin Treatment in Older Adults With Chronic Insomnia: A Randomised Controlled Trial

Key Details

Gender

All

Age Range

60 Years - Any

Study Type

INTERVENTIONAL

Enrollment

183

Start Date

2026-08-01

Completion Date

2029-08-01

Last Updated

2026-07-10

Healthy Volunteers

No

Interventions

BEHAVIORAL

Cognitive behavioural therapy for insomnia

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.

DIETARY_SUPPLEMENT

Melatonin 3 mg immediate-release

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.

BEHAVIORAL

Psychoeducation

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.

DRUG

Placebo Oral Tablet

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.

Locations (1)

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

Hong Kong, Hong Kong