Prevention of Insomnia Using a Stepped Care Model in Adults
ConditionSleep Disturbance
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. Our previous study has shown that insomnia can be prevented through a brief cognitive behavioral prevention program in adolescents. However, there is very limited data in the adult population.
Current study aims to evaluate a digital sleep-focused platform which consists of different intervention plan according to user's insomnia severity level and employed a stepped care model. Thus, the effectiveness of the stepped care model will be evaluated in a real world setting using stepped wedge cluster randomized controlled design to evaluate potential preventive effect on adults who only with mild insomnia symptoms. The program will be rolled out to different districts in Hong Kong sequentially in 18 districts over 4 steps with a equally spaced time periods. The primary aim of this study is to evaluate the effects of a stepped-care CBT-I model in improving sleep and prevent the incidence of insomnia among participants with mild insomnia.
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 prevention program for insomnia (CBP-I)
BehavioralCBP-I will be provided to participants once their districts are exposed.
Treatment groups
1,016 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 postintervention 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