Prevention of Insomnia Using a Stepped Care Model in Adults
NCT ID: NCT06156293
Last Updated: 2025-07-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
1016 participants
INTERVENTIONAL
2023-12-01
2026-06-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
NONE
Study Groups
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Stepped-care CBT-I group
A total of 3 steps of sleep focused intervention will be provided, with the objectives to increase the awareness of sleep health, increase sleep literacy, establish good sleep hygiene and treat insomnia.
Step 1: self-help digital sleep focused program; Step 2: guided intervention; Step 3: individualized consultation.
Cognitive behavioral prevention program for insomnia (CBP-I)
CBP-I will be provided to participants once their districts are exposed.
Control group
Participants in the control group remain unexposed to the stepped-care sleep-focused intervention.
No interventions assigned to this group
Interventions
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Cognitive behavioral prevention program for insomnia (CBP-I)
CBP-I will be provided to participants once their districts are exposed.
Eligibility Criteria
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Inclusion Criteria
2. The score of Insomnia Severity Index \< 10.
Exclusion Criteria
2. present with severe depression or suicidal ideation,
3. present with neurodegenerative diseases that prevent participant from completing the intervention (e.g., dementia and Parkinson's disease).
4. unable to provide consent
18 Years
70 Years
ALL
Yes
Sponsors
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Chinese University of Hong Kong
OTHER
Responsible Party
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CHAN NGAN YIN
Assistant Professor
Principal Investigators
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Yun Kwok Wing, FRCPsych
Role: PRINCIPAL_INVESTIGATOR
Department of Psychiatry, the Chinese University of Hong Kong
Locations
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Department of Psychiatry, the Chinese University of Hong Kong
Hong Kong, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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20230816.02
Identifier Type: -
Identifier Source: org_study_id
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