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

NCT07695246 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 183

Last updated 2026-07-10

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

  • Chinese University of Hong Kong

    collaborator OTHER

  • The University of Hong Kong

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-01
Primary Completion
2029-08-01
Completion
2029-08-01

Countries

  • Hong Kong

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07695246 on ClinicalTrials.gov