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Could a Web-Based therapy ease everyday mental distress?

NCT ID NCT06804954

Symptom relief Sponsor: Karolinska Institutet 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 17, 2026 · Last updated Aug 18, 2026 · Updated 1 time

Summary

This trial tests whether an internet-based cognitive behavior therapy (CBT) program can reduce symptoms of anxiety, depression, and stress in adults with mild mental health issues who visit primary care. Participants are randomly assigned to either the online CBT program, which includes modules and therapist feedback, or to usual primary care. The study compares changes in symptom scores over time to see if the online approach offers added benefit.

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 transdiagnostic cognitive behavior therapy (CBT)
What this could lead to
If effective, this could offer a scalable, accessible treatment option for people with mild mental health symptoms, potentially reducing the burden on primary care.
What could go wrong
The trial is early and the effect compared to usual care may be modest. Also, the online format may not suit everyone, and long-term benefits are uncertain.

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 500 people

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

Started

Feb 2025

Expected to finish

Feb 2029

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 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: To be included patients have to: 1. To be included patients have to: (a) have a subsyndromal mental health problem concerning anxiety, depressive symptoms, or stress-related ill-health that warrants treatment, 2. be at least 18 years old, 3. have regular access to a device with an Internet connection, 4. be able to read and write in Swedish, 5. have no severe psychiatric disorder that requires specialized psychiatric care, such as psychosis, bipolar disorder, or anorexia nervosa, 6. if on medication with monoamine agonist, have stable dosage in the past month, 7. have no on-going psychological treatment, and 8. provide written informed consent for participation and complete baseline assessment Exclusion criteria: As the targeted population in this trial is primary care patients with subsyndromal mental ill-health that do not have a manifest specific common mental disorder, patients will be excluded if they meet diagnostic criteria for an anxiety disorder (social phobia, panic disorder, agoraphobia, general anxiety disorder, or specific phobia), a health anxiety disorder (hypochondriasis or illness anxiety disorder), obsessive-compulsive disorder, depression (depression or dysthymia), or a stress-related disorder (exhaustion disorder, adjustment disorder, or post-traumatic stress disorder). Note that meeting diagnostic criteria for not otherwise specified disorders (e.g., anxiety not otherwise specified), mixed anxiety and depressive disorder, or disorders subsumed under "other" categories is not a reason for exclusion.

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Conditions

The condition(s) this trial relates to.

psychiatric disorder

As listed by the trial registrant

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

Mental ill-health

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

  • Region Stockholm, Gustavsberg Primary Care Center

    RECRUITING

    Gustavsberg, Stockholm County, 134 40, Sweden

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Other studies related to the condition(s) this trial covers.