Effectiveness of a Stepped Care Model to Deliver Cognitive-behaviour Therapy for Insomnia 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. Cognitive behavioral therapy for insomnia (CBT-I) is the first line treatment for adult insomnia due to its comparable effect to medication in short term but is more sustainable in the long run. However, only a few sufferers have received CBT-I, due to limited accessibility, lack of trained sleep therapists, time costing and geographical limitations. To increase CBT-I accessibility, different formats of CBT-I have been proposed. Empirical evidence including ours consistently suggested that self-help digital CBT-I is effective in improving sleep while its augmentation with a guided approach could further enhance the treatment gain. Previous evidence has suggested that although self-help CBT-I could lead to positive outcomes, the drop out rate is quite high and maybe less effective for patients with comorbidity or high level of distress. Thus, a stepped-care approach to CBT-I that utilizes online self help and therapist-guided modes of delivery might be a potential way to facilitate efficient dissemination of effective insomnia treatment resources. The effectiveness of the stepped care model will be evaluated in a real world setting using stepped-wedge cluster randomized controlled design. The program will be rolled out to different districts in Hong Kong sequentially in 18 districts over 4 steps with a eqaully spaced time periods.

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
Hong Kong Special Administrative Region
Department of Psychiatry, the Chinese University of Hong Kong
RECRUITING
Shatin
Contact Information
Primary
Rachel Ngan Yin Chan, PhD
rachel.chan@cuhk.edu.hk
39710548
Backup
Jucheng Yu, PhD
juchengyu@cuhk.edu.hk
39710548
Time Frame
Start Date: 2023-10-23
Estimated Completion Date: 2026-04-22
Participants
Target number of participants: 1100
Treatments
Experimental: Stepped-care CBT-I group
A total of 3 steps of CBT-I 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 CBT-I program; Step 2: guided CBT-I program; Step 3: individualized consultation.
No_intervention: Control group
Participants in the control group remain unexposed to the stepped-care CBT-I intervention.
Related Therapeutic Areas
Sponsors
Leads: Chinese University of Hong Kong

This content was sourced from clinicaltrials.gov