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Online sleep therapy may ease anxiety too

NCT ID NCT06567210

Symptom relief Sponsor: Woolcock Institute of Medical Research 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether an online, therapist-guided program for insomnia can also reduce anxiety symptoms. 98 adults with both chronic insomnia and anxiety will either start the program immediately or after a delay. The program includes sleep education, behavioural strategies, and relaxation techniques, and researchers will track changes in anxiety, sleep, and brain activity.

What this could mean

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

Active substance
online cognitive behavioural and circadian therapy for insomnia (CBCTi)
What this could lead to
If it works, this could offer a widely accessible online treatment that eases both insomnia and anxiety symptoms.
What could go wrong
This is a small early-stage trial with 98 participants, so results may not apply to everyone. The therapy requires time and effort, and not everyone may benefit.

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 98 people

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

Expected to start

Jan 2026

An estimate. Start dates often move.

Expected to finish

Jun 2030

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 45 years

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: * (A or B) and (C) A. Diagnosis of insomnia disorder (DSM-5-TR) B. Insomnia Severity Index (ISI) score ≥ 10 C. Generalized Anxiety Disorder (GAD-7) score ≥ 10 * All sexes and genders. * Between 18 and 45 years of age. * Able to provide informed consent. * Proficient in English. Exclusion Criteria: x Sleep or circadian disorder other than insomnia (e.g., hypersomnolence, periodic limb movement disorder, advanced or delayed sleep phase disorder, moderate to severe sleep apnoea disorder based on previous sleep study with an apnea-hypopnea index ≥ 15 and/or finger-pulse oximetry oxygen desaturation index (ODI) ≥ 10). * Current or history of neurological disorders (e.g., stroke, brain injury). * Current or history of bipolar disorder, psychosis, or moderate to severe obsessive-compulsive disorder. * Current uncontrolled mental health disorders requiring specialist care, other than major depression and anxiety disorders. * Centrally active agents or presence of medical condition that may affect participation. * Pregnancy or actively trying to conceive, or lactating. * Shift work for at least 2 shifts per week in the past 3 months (i.e., work between 21:00 and 6:00). * Travel across time zones over 3 hours difference in the previous 30 days (will require a 1-day adjustment period per hour of time zone travelled). * Unwilling to know about potential incidental findings. * No consent or adherence to instructions for any part of the study protocol.

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Conditions

The condition(s) this trial relates to.

anxiety anxiety disorder insomnia

As listed by the trial registrant

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

Anxiety Insomnia chronic

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

  • Woolcock Institute of Medical Research

    RECRUITING

    Macquarie Park, New South Wales, 2109, Australia

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