NCT07695246

Brief 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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
183

participants targeted

Target at P75+ for not_applicable

Timeline
37mo left

Started Aug 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 13, 2026

Completed
27 days until next milestone

First Posted

Study publicly available on registry

July 10, 2026

Completed
22 days until next milestone

Study Start

First participant enrolled

August 1, 2026

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2029

Last Updated

July 10, 2026

Status Verified

July 1, 2026

Enrollment Period

3 years

First QC Date

June 13, 2026

Last Update Submit

July 5, 2026

Conditions

InsomniaAgingSleep Disorders

Keywords

InsomniaElderlyCBTMelatoninCircadian RhythmSleepRandomised controlled trialOlder adults

Outcome Measures

Primary Outcomes (1)

  • Insomnia Symptoms - Insomnia Severity Index

    Insomnia symptoms measured by Insomnia Severity Index (ISI). ISI is a 5-item self-rated scale. Possible scores range from 0 to 20, with higher scores indicating greater insomnia severity.

    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.

Secondary Outcomes (52)

  • Treatment Response of Insomnia

    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.

  • Remission of insomnia

    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.

  • Self Report Sleep Quality - The Pittsburgh Sleep Quality Index

    Baseline, 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.

  • Self-Report Chronotype Measures The Munich Chronotype Questionnaire

    Baseline, 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.

  • Self-Report Chronotype Preference: The Morningness-Eveningness Questionnaire

    Baseline, 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.

  • +47 more secondary outcomes

Study Arms (3)

CBT-I + Melatonin

EXPERIMENTAL

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.

Behavioral: Cognitive behavioural therapy for insomniaDietary Supplement: Melatonin 3 mg immediate-release

CBT-I + Placebo

ACTIVE COMPARATOR

Identical four weekly group-based CBT-I sessions plus placebo capsule (identical appearance) taken 30 min before habitual bedtime for 4 weeks.

Behavioral: Cognitive behavioural therapy for insomniaDrug: Placebo Oral Tablet

Psychoeducation + Placebo

PLACEBO COMPARATOR

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.

Behavioral: PsychoeducationDrug: Placebo Oral Tablet

Interventions

Cognitive behavioural therapy for insomniaBEHAVIORAL

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.

CBT-I + MelatoninCBT-I + Placebo
Melatonin 3 mg immediate-releaseDIETARY_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.

CBT-I + Melatonin
PsychoeducationBEHAVIORAL

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.

Psychoeducation + Placebo
Placebo Oral TabletDRUG

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.

CBT-I + PlaceboPsychoeducation + Placebo

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Having a current diagnosis or a history of manic or hypomanic episodes, schizophrenia spectrum disorders, neurodevelopmental disorders, neurocognitive disorders, organic mental disorders, intellectual disabilities, or substance abuse or dependence.
  • Having a progressive medical condition directly related to the onset and course of insomnia (e.g., cancer, chronic pain).
  • Undergoing treatment for diseases known to affect sleep (e.g., chemotherapy).
  • Having an untreated sleep disorder that may disrupt sleep continuity and quality (e.g., sleep-disordered breathing) except for insomnia disorder and circadian sleep-wake phase disorder.
  • Having mild to significant cognitive impairment, defined by having a score of \< 22 on MOCA.
  • Concurrent and regular use of extraneous melatonin or melatonin agonist (e.g., ramelteon).
  • Receiving concurrent psychological treatment for insomnia.
  • Meeting potential contraindications for melatonin (e.g., undergoing dialysis) or concurrently using medications that have a potential drug interaction with melatonin (e.g., anticoagulant and anti-platelet).
  • Being a night shift worker.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance DisordersSleep Wake Disorders

Interventions

Cognitive Behavioral TherapyMelatonin

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasNervous System DiseasesMental DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesTryptaminesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Central Study Contacts

Shirley Xin LI, DClinPsy, PhD

CONTACT

852 39177035shirleyx@hku.hk

Zihan Chen, MS

CONTACT

852 93675825zihan.chen@connect.hku.hk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Melatonin and placebo tablets are identical in appearance. Participants are blinded to their tablet assignment. Outcome assessors are blinded to treatment allocation throughout. Therapists delivering CBT-I are not blinded to the therapy arm but are blinded to tablet assignment.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 13, 2026

First Posted

July 10, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

August 1, 2029

Study Completion (Estimated)

August 1, 2029

Last Updated

July 10, 2026

Record last verified: 2026-07

Locations

HK(1)