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
Qualifiers
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
Treatments tested in this trial
- Cognitive behavioural therapy for insomnia
- Melatonin 3 mg immediate-release
- Psychoeducation
- Placebo Oral Tablet
Treatment groups
183 Participants
are divided into 3 treatment groupsSponsors and collaborators
The University of Hong Kong
Lead sponsor
Chinese University of Hong Kong
Collaborator
Source ClinicalTrials.gov