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Lay-led sleep therapy shows promise for older adults with insomnia

NCT ID NCT07486973

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

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This pilot study tests whether a short, four-session cognitive behavioural therapy for insomnia (CBT-I) group, led by trained laypersons, can improve sleep quality in older adults in Hong Kong. Fifty participants aged 45 and older with mild depression and sleep problems will either join the group or receive a sleep hygiene booklet. The study will measure changes in sleep quality and how acceptable the program is.

What this could mean

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

Active substance
Cognitive behavioural therapy for insomnia (CBT-I) delivered in a group format by trained laypersons
What this could lead to
If it works, this could offer a low-cost, scalable way to improve sleep in older adults without needing a specialist.
What could go wrong
This is a small pilot study with only 50 participants, so results may not apply widely. The intervention is brief and led by non-experts, which may limit its effectiveness.

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 50 people

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

Expected to start

Mar 2026

An estimate. Start dates often move.

Expected to finish

Dec 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

45 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * Aged 45 or older * Have a PHQ-9 score between 5-9, and item 3 must be scored at 2 or higher * Experiencing existing symptoms of depression and sleep disturbance * Capable of providing informed consent for their participation in the study Exclusion Criteria: * Known history of intellectual disabilities, schizophrenia spectrum disorders, bipolar disorder, Parkinson's disease, or dementia * Assessed to be at active suicidal risk * Significant difficulties in communication

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Conditions

The condition(s) this trial relates to.

insomnia Sleep Hygiene

As listed by the trial registrant

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

Sleep quality

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 Social Work and Social Administration, The University of Hong Kong

    Hong Kong, Hong Kong

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