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Could exercise boost online therapy for insomnia?

NCT ID NCT07794943

Symptom relief Sponsor: Uppsala County Council, Sweden Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 31, 2026 · Last updated Sep 01, 2026 · Updated 1 time

Summary

This trial tests whether adding physical activity support to internet-based cognitive behavioral therapy for insomnia (iCBT-I) helps adults with sleep problems and low activity levels sleep better and move more. Participants receive either standard online insomnia therapy or the same therapy plus physical activity components over 6 to 8 weeks. Researchers measure insomnia severity, physical activity, mood, thinking, and quality of life at several points up to a year later. The goal is to see if the combined approach leads to greater improvements in sleep and activity than therapy alone.

What this could mean

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

Active substance
Internet-based cognitive behavioral therapy for insomnia, with or without added physical activity support
What this could lead to
If it works, this could point toward a more effective, accessible treatment for insomnia that also boosts physical activity, improving overall health.
What could go wrong
The trial is in early phases, so results may not hold up in larger studies. Adding physical activity support may not provide extra benefit over standard online therapy, and adherence to the program could be low.

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 355 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Dec 2032

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

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

Ages

18 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: * 18 years or older * Experiencing clinically relevant insomnia (Insomnia Severity Index score \>10) * Do not meet the recommended levels of physical activity (weekly 150-300 minutes of moderate intensity physical activity or 75-150 minutes of vigorous physical activity) Exclusion Criteria: * Have any ongoing diagnosed medical conditions known to affect PA participation as assessed by intervention clinician. * Increased risk for suicide as assessed by intervention clinician.

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Conditions

The condition(s) this trial relates to.

insomnia Motor Activity Sedentary Behavior

As listed by the trial registrant

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

Insomnia disorders Physical inactivity

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

  • Primary care and health, Region Uppsala

    Uppsala, Sweden

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