Clinical trial NCT06156293: Prevention of Insomnia Using a Stepped Care Model in Adults
Official title: Prevention of Insomnia Using a Stepped Care Model in Adults: a Pragmatic Stepped-wedge Cluster Randomized Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sleep Disturbance
Keywords: Sleep Disturbance
Stepped care model
Stepped wedge cluster randomized trial
Prevention program
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2023-12-05
Enrollment: 1016
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Pragmatic stepped wedge design - over 4 months, 18 sites enter trial at 1 month intervals.
Primary purpose: PREVENTION

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

1. Chinese adults aged 18-70 years old,
2. The score of Insomnia Severity Index \< 10.

Exclusion Criteria:

1. present with psychotic disorders such as bipolar disorder and schizophrenia,
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

Primary outcomes:
measure: Insomnia severity index
timeFrame: 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 outcomes:
measure: Severity of depression
timeFrame: 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
measure: Severity of anxiety
timeFrame: 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
measure: Health-related quality of life
timeFrame: 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
measure: Chronic insomnia diagnosis
timeFrame: 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
measure: Medication usage
timeFrame: 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
measure: Clinical global impression
timeFrame: 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
measure: Patient-report clinical global impression
timeFrame: 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
measure: Sleep duration
timeFrame: 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
measure: Subjective sleep as measured by sleep diary
timeFrame: 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
measure: Healthcare resource use
timeFrame: 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
measure: Work and social functioning
timeFrame: 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
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Department of Psychiatry, the Chinese University of Hong Kong
Study officials:
affiliation: Department of Psychiatry, the Chinese University of Hong Kong
name: Yun Kwok Wing, FRCPsych
role: PRINCIPAL_INVESTIGATOR
References: