Prevention of Insomnia Using a Stepped Care Model in Adults: a Pragmatic Stepped-wedge Cluster Randomized Trial

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: t
View:

• Chinese adults aged 18-70 years old,

• The score of Insomnia Severity Index \< 10.

Locations
Other Locations
China
Department of Psychiatry, the Chinese University of Hong Kong
RECRUITING
Hong Kong
Contact Information
Primary
Rachel Ngan Yin Chan
rachel.chan@cuhk.edu.hk
39710550
Backup
Jucheng Yu, PhD
juchengyu@cuhk.edu.hk
39710550
Time Frame
Start Date: 2023-12-01
Estimated Completion Date: 2026-06-01
Participants
Target number of participants: 1016
Treatments
Experimental: 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.
No_intervention: Control group
Participants in the control group remain unexposed to the stepped-care sleep-focused intervention.
Related Therapeutic Areas
Sponsors
Leads: Chinese University of Hong Kong

This content was sourced from clinicaltrials.gov