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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral, Drug, Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 60
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Hong Kong Special Administrative Region
Sleep Research Clinic and Laboratory, Department of Psychology, The University of Hong Kong
RECRUITING
Hong Kong
Contact Information
Primary
Shirley Xin LI, DClinPsy, PhD
shirleyx@hku.hk
852 39177035
Backup
Zihan Chen, MS
zihan.chen@connect.hku.hk
852 93675825
Time Frame
Start Date: 2026-08-01
Estimated Completion Date: 2029-08-01
Participants
Target number of participants: 183
Treatments
Experimental: CBT-I + Melatonin
Four weekly group-based CBT-I sessions (120-min, 6-8 participants) plus oral melatonin 3 mg immediate-release taken 30 min before habitual bedtime for 4 weeks.
Active_comparator: CBT-I + Placebo
Identical four weekly group-based CBT-I sessions plus placebo capsule (identical appearance) taken 30 min before habitual bedtime for 4 weeks.
Placebo_comparator: Psychoeducation + Placebo
Four weekly group-based sleep psychoeducation sessions (sleep hygiene, healthy diet, and exercise for older adults; no active CBT-I components) plus placebo capsule for 4 weeks.
Related Therapeutic Areas
Sponsors
Collaborators: Chinese University of Hong Kong
Leads: The University of Hong Kong

This content was sourced from clinicaltrials.gov