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NCT Number: NCT06109363

A Stepped Care Model to Deliver CBT-I in Community

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.

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Key information

Conditions

Insomnia Dyssomnias Mental Disorders Nervous System Diseases Parasomnias Sleep Disorders, Intrinsic Sleep Disturbance Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive Behavioral Therapy for Insomnia (CBT-I)

Behavioral

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

Primary outcomes

  1. Insomnia severity index

    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

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

Secondary outcomes

  1. 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

    Patient Health Questionnaire-9 (PHQ-9) will be used to measure the severity of depression.

  2. 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

    General Anxiety Disorder-7 (GAD-7) will be used to measure the severity of anxiety.

  3. 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

    The health-related quality of life (HRQoL) will be measured by the EuroQol-5D (EQ).

  4. 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

    A checklist based on Diagnostic and statistical manual of mental disorders will be implemented to measure the incidence of chronic insomnia.

  5. 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

    A checklist will be used to measure the subject's medication usage change over the past 3 months.

  6. 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

    Clinical Global Impression (CGI) will be used to assess the overall improvement or change in a patient's condition over time.

  7. 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

    A single-item CGI will be used to ask the participant whether they experience sleep improvement or change over the past week or not.

  8. 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

    Two self-report questions will be used to record the sleep duration during weekdays and weekends of the participants.

  9. 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

    Self-report sleep diary will be used to record subjective sleep of the participants including total time in bed, sleep onset latency, total sleep duration, sleep efficiency and wake after sleep onset.

  10. 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

    The use and expense of sleep-promoting medication, psychotherapy, and other complementary treatments for sleep improvement over the past 3 months will be collected from individual participants using a self-developed questionnaire, with a focus on their healthcare resource utilization.

  11. 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

    A 5-item questionnaire developed from Work and Social Adjustment Scale (WSAS) will be used to measure the daytime functioning of the participants such as ability to work, home management, social and private leisure activities, and close relationship maintenance.

Study contacts

Contact information is provided by the study sponsor or research team.

Jucheng Yu, PhD

CONTACT

[email protected]

39710548

Rachel Ngan Yin Chan, PhD

CONTACT

[email protected]

39710548

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

Effectiveness of a Stepped Care Model to Deliver Cognitive-behaviour Therapy for Insomnia in Adults, a Pragmatic Stepped-wedge Cluster Randomized Trial

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Oct 31, 2023
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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