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New stepped care model aims to bring insomnia help to thousands

NCT ID NCT06109363

Symptom relief Sponsor: Chinese University of Hong Kong Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a stepped care model for delivering cognitive behavioral therapy for insomnia (CBT-I) to 1100 adults across 18 districts in Hong Kong. Participants first receive online self-help CBT-I, and those who need more support get therapist-guided sessions. The goal is to see if this approach improves sleep and is practical to roll out widely.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
cognitive behavioral therapy for insomnia (CBT-I) delivered via online self-help and therapist-guided sessions
What this could lead to
If successful, this stepped care model could make effective insomnia treatment more accessible and scalable for large populations.
What could go wrong
This is a pragmatic real-world trial, not a placebo-controlled study, so results may be influenced by external factors. Dropout rates may be high, and the approach may be less effective for people with severe mental health conditions.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 1,100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2023

Expected to finish

Apr 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

insomnia Parasomnias sleep disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Insomnia Sleep disturbance

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Department of Psychiatry, the Chinese University of Hong Kong

    RECRUITING

    Shatin, New Territories, Hong Kong

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