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

Sponsor
The University of Hong Kong
Study ID
NCT07695246
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
60 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

First listed
Jul 10, 2026
Start date
Aug 1, 2026
Status verified
Aug 2026
Primary completion
Aug 1, 2029
Completion
Aug 1, 2029

Study Design

Enrollment
183 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Insomnia Symptoms - Insomnia Severity Index [ Time Frame: Baseline, Mid-session (Week 2 of the intervention), Post-Treatment (one-week after treatment conclusion) for all participants, and at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups. ]

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