Prevention of Insomnia Using a Stepped Care Model in Adults
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cognitive behavioral prevention program for insomnia (CBP-I).
- Who it may be relevant to
- Registry conditions: Sleep Disturbance. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Prevention of Insomnia Using a Stepped Care Model in Adults: a Pragmatic Stepped-wedge Cluster Randomized Trial
Overview
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.
Detailed description
This interventional study will be a multicenter, assessor-blinded, pragmatic stepped-wedge cluster randomized controlled trial. A total of 18 districts will be included in the study and the randomization will be carried out based on the districts. The stepped-care CBT-I intervention will be sequentially rolled out to the 4-6 districts per step according to a computer-generated random number while the remaining clusters will continue to stay unexposed to the CBT-I intervention over the control period. Therefore after 4-step exposure, all clusters will receive the stepped-care CBT-I intervention. A total of 3 follow-up assessments (post intervention, 3-month and 12-month follow up) will be conducted to assess the effectiveness and long-term effects of the stepped care model.
Interventions
- Behavioral Cognitive behavioral prevention program for insomnia (CBP-I)
CBP-I will be provided to participants once their districts are exposed.
Primary outcome measures
- Insomnia severity index [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 up]
Secondary outcome measures (11)
- 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 up]
- 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 up]
- Health-related quality of life [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 up]
- Chronic insomnia diagnosis [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 up]
- Medication usage [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 up]
- Clinical global impression [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 up]
- Patient-report clinical global impression [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 up]
- Sleep duration [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 up]
- Subjective sleep as measured by sleep diary [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 up]
- Healthcare resource use [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 up]
- Work and social functioning [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 up]
Eligibility criteria
Inclusion criteria
- Chinese adults aged 18-70 years old,
- The score of Insomnia Severity Index < 10.
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
China · 1 center
- Department of Psychiatry, the Chinese University of Hong Kong — Hong Kong
Identifiers
NCT: NCT06156293 · 20230816.02