Prevention of Insomnia Using a Stepped Care Model in Adults

March 19, 2026 updated by: CHAN NGAN YIN, Chinese University of Hong Kong

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1016

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
      • Hong Kong, China
        • Recruiting
        • Department of Psychiatry, the Chinese University of Hong Kong
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Chinese adults aged 18-70 years old,
  2. The score of Insomnia Severity Index < 10.

Exclusion Criteria:

  1. present with psychotic disorders such as bipolar disorder and schizophrenia,
  2. present with severe depression or suicidal ideation,
  3. present with neurodegenerative diseases that prevent participant from completing the intervention (e.g., dementia and Parkinson's disease).
  4. unable to provide consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: Cognitive behavioral prevention program for insomnia (CBP-I)
CBP-I will be provided to participants once their districts are exposed.
No Intervention: Control group
Participants in the control group remain unexposed to the stepped-care sleep-focused intervention.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
Post-intervention (ranging from 8 weeks to 24 weeks, depending on the treatment level), 3-month postintervention and 12-month post-intervention follow up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
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
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.
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
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).
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
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.
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-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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chinese University of Hong Kong

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Yun Kwok Wing, FRCPsych, Department of Psychiatry, the Chinese University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 27, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 27, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 5, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 23, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 19, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20230816.02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Sleep Disturbance

Clinical Trials on Cognitive behavioral prevention program for insomnia (CBP-I)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings