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Structured treatment plan may boost depression care in GP clinics

NCT ID NCT07263321

Symptom relief Sponsor: Aalborg University Hospital 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 compares three ways to treat moderate depression in adults aged 18-65: usual care from a general practitioner, behavioral therapy from a psychologist, or a structured step-by-step treatment plan from a GP. The goal is to see if the structured plan works better at easing depression symptoms. Participants will be followed for 12 weeks with regular check-ins.

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 171 people

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

Expected to start

Dec 2025

An estimate. Start dates often move.

Expected to finish

Jun 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 65 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: 1. The participant must be referred to the study with a diagnosis of unipolar depressive disorder, as judge by the GP. 2. Severity of the depressive episode corresponding to moderate depression, as judged by the GP. 3. Clinical uncertainty regarding which of the treatments, medication or psychotherapy, would be the better choice in the case concerned. 4. Age criteria: Participants must be at least 18 years old and no more than 65 years old at the time of randomisation. 5. The participant must be a patient in general practice. 6. Participants must be able to participate in virtual meetings (e.g. by phone or computer) and have e-Boks. 7. The participant must be willing to receive psychotherapy by a psychologist and/or medication. 8. Must have signed the document of informed consent. Exclusion Criteria: 1. Misuse of substances that might influence the study, as judged by the investigator. 2. Difficulty in understanding the Danish language, as judged by the investigator. 3. A diagnosis of dementia. 4. Medical conditions that might interfere with the study outcome or safety, judged so by the investigator. 5. Pregnancy. 6. High risk of non-adherence at the investigator's discretion. 7. Suicidality: according to C-SSRS with a positive response to question 4 or 5 within the last three months or upon investigator's discretion. 8. No current medical or psychotherapy treatment initiated within the last 4 weeks prior to screening.

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Conditions

The condition(s) this trial relates to.

Depression depressive disorder major depressive disorder

As listed by the trial registrant

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

Depression Depression - major depressive disorder Depressive disorder Depressive disorder, major depressive disorder Depressive disorders Depressive episode Depressive episodes

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

  • Aalborg University Hospital, Department of Psychiatry

    RECRUITING

    Aalborg, Denmark

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