Efficacy of CBT-I With Adjuvant Melatonin in Older Adults Chronic Insomnia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorThe University of Hong Kong
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Cognitive behavioural therapy for insomnia
BehavioralCBT-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 supplementMelatonin 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
BehavioralFour 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
DrugPlacebo 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.
Treatment groups
183 Participants
are divided into 3 treatment groupsGroup A: CBT-I + MelatoninExperimental treatment 2 interventions
Group B: CBT-I + PlaceboActive comparator 2 interventions
Group C: Psychoeducation + PlaceboPlacebo comparator 2 interventions
Trial outcomes
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.
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.Secondary outcomes
1
Treatment Response of Insomnia
Defined as a decrease of ≥ 8 points on the ISI (self-reported)
Time frame
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.2
Remission of insomnia
Insomnia remission is defined as an ISI score less than 8. The outcome will be reported as the number and percentage of participants meeting remission criteria.
Time frame
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.3
Self Report Sleep Quality - The Pittsburgh Sleep Quality Index
Pittsburgh Sleep Quality Index (PSQI) is a self-rated scale consisting of 19 questions. All items are combined to form seven component scores on different aspects of sleep quality, each of which ranges from 0 to 3 points with higher scores representing more sleep disturbance. The seven component scores are added to one global score, which ranges from 0 to 21, with higher scores indicating more difficulties with sleep.
Time frame
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.4
Self-Report Chronotype Measures The Munich Chronotype Questionnaire
The Munich Chronotype Questionnaire (MCTQ) is a self-report measures of sleeping patterns during weekdays and weekends separately. The Mid-Sleep Time (MSF/MSFsc) are used to as an indicator of chronotype, where individuals with earlier mid-sleep time reflect a morning chronotype and later mid-sleep time reflect an evening chronotype.
Time frame
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.Sponsors and contacts
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The University of Hong Kong
Lead sponsor
Chinese University of Hong Kong
Collaborator
Source ClinicalTrials.gov