A Stepped Care Model to Deliver CBT-I in Community
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorChinese University of Hong Kong
About this trial
Insomnia is one of the most common sleep disorders and affects approximately 10 - 40% of the population across different age groups in Hong Kong. Cognitive behavioral therapy for insomnia (CBT-I) is the first line treatment for adult insomnia due to its comparable effect to medication in short term but is more sustainable in the long run. However, only a few sufferers have received CBT-I, due to limited accessibility, lack of trained sleep therapists, time costing and geographical limitations. To increase CBT-I accessibility, different formats of CBT-I have been proposed. Empirical evidence including ours consistently suggested that self-help digital CBT-I is effective in improving sleep while its augmentation with a guided approach could further enhance the treatment gain. Previous evidence has suggested that although self-help CBT-I could lead to positive outcomes, the drop out rate is quite high and maybe less effective for patients with comorbidity or high level of distress.
Thus, a stepped-care approach to CBT-I that utilizes online self help and therapist-guided modes of delivery might be a potential way to facilitate efficient dissemination of effective insomnia treatment resources. The effectiveness of the stepped care model will be evaluated in a real world setting using stepped-wedge cluster randomized controlled design. The program will be rolled out to different districts in Hong Kong sequentially in 18 districts over 4 steps with a eqaully spaced time periods.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Chinese adults aged 18-70 years old,
The score of Insomnia Severity Index ≥ 10.
Disqualifiers
present with psychotic disorders such as bipolar disorder and schizophrenia,
present with severe depression or suicidal ideation,
present with neurodegenerative diseases that prevent participant from completing the intervention (e.g., dementia and Parkinson's disease).
unable to provide consent
Trial design
Design model
Crossover
Treatments tested in this trial
Cognitive behavioral therapy for insomnia (CBT-I)
BehavioralCBT-I intervention will be provided to participants once their districts are exposed.
Treatment groups
1,100 Participants
are divided into 2 treatment groupsGroup A: Stepped-care CBT-I groupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Insomnia severity index
The primary outcome will be the perceived insomnia severity measured by Insomnia Severity Index (ISI).
Time frame
Post-intervention (ranging from 8 weeks to 24 weeks, depending on the treatment level), 3-month post-intervention and 12-month post-intervention follow upSecondary outcomes
1
Severity of depression
Patient Health Questionnaire-9 (PHQ-9) will be used to measure the severity of depression.
Time frame
Post-intervention (ranging from 8 weeks to 24 weeks, depending on the treatment level), 3-month post-intervention and 12-month post-intervention follow up2
Severity of anxiety
General Anxiety Disorder-7 (GAD-7) will be used to measure the severity of anxiety.
Time frame
Post-intervention (ranging from 8 weeks to 24 weeks, depending on the treatment level), 3-month post-intervention and 12-month post-intervention follow up3
Health-related quality of life
The health-related quality of life (HRQoL) will be measured by the EuroQol-5D (EQ).
Time frame
Post-intervention (ranging from 8 weeks to 24 weeks, depending on the treatment level), 3-month post-intervention and 12-month post-intervention follow up4
Chronic insomnia diagnosis
A checklist based on Diagnostic and statistical manual of mental disorders will be implemented to measure the incidence of chronic insomnia.
Time frame
Post-intervention (ranging from 8 weeks to 24 weeks, depending on the treatment level), 3-month post-intervention and 12-month post-intervention follow upSponsors and contacts
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Source ClinicalTrials.gov