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NCT Number: NCT06156293

Prevention of Insomnia Using a Stepped Care Model in Adults

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.

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Key information

Conditions

Sleep Disturbance Mental Disorders Nervous System Diseases Parasomnias 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 prevention program for insomnia (CBP-I)

Behavioral

CBP-I 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 postintervention 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.

  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 insomnia severity 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 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]

39710550

Rachel Ngan Yin Chan

CONTACT

[email protected]

39710550

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Dec 5, 2023
Registry last updated
Mar 23, 2026

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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