A Stepped Care Model to Deliver CBT-I in Community

NCT06109363 | Recruiting

• 1 other identifier: 20230816
• Study Type: interventional
• Target: 1,100
• Locations: 1 country
• Sites: 1

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. 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.

Conditions

Insomnia; Sleep Disturbance

Keywords

Insomnia; Stepped care model; Stepped wedge cluster randomized trial

Outcome Measures

Primary Outcomes (1)

• Insomnia severity index

  The primary outcome will be the perceived insomnia severity measured by Insomnia Severity Index (ISI).

  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

Secondary Outcomes (11)

• Severity of depression

  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

  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

  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

  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

  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

Study Arms (2)

Stepped-care CBT-I group

EXPERIMENTAL

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.

Behavioral: Cognitive behavioral therapy for insomnia (CBT-I)

Control group

NO INTERVENTION

Participants in the control group remain unexposed to the stepped-care CBT-I intervention.

Interventions

Cognitive behavioral therapy for insomnia (CBT-I) BEHAVIORAL

CBT-I intervention will be provided to participants once their districts are exposed.

Stepped-care CBT-I group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chinese adults aged 18-70 years old,
• The score of Insomnia Severity Index ≥ 10.

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Department of Psychiatry, the Chinese University of Hong Kong

Shatin, New Territories, Hong Kong

RECRUITING

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Parasomnias

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Yun Kwok Wing, FRCPsych

  Department of Psychiatry, the Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rachel Ngan Yin Chan, PhD

CONTACT

39710548; rachel.chan@cuhk.edu.hk

Jucheng Yu, PhD

CONTACT

39710548; juchengyu@cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Psychiatry

Model Details: Pragmatic stepped wedge design - over 4 months, 18 sites enter trial at 1 month intervals. 2

Study Record Dates

• First Submitted: October 13, 2023
• First Posted: October 31, 2023
• Study Start: October 23, 2023
• Primary Completion (Estimated): October 22, 2026
• Study Completion (Estimated): April 22, 2027
• Last Updated: June 24, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)