Step-by-step care plan to improve treatment for moderate depression in general practice

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized study will enroll 171 adults with moderate unipolar depression seen in general practice and assign them to one of three treatments: usual GP care, psychologist-delivered behavioral therapy, or a GP-delivered algorithmic step-by-step care plan with predetermined follow-ups and medication decision rules. The step-by-step arm uses a structured protocol that specifies when to start, increase, or switch medications and schedules follow-up contacts. Participants must be willing to receive psychotherapy and/or medication and be able to take part in virtual meetings and use e-Boks. Outcomes will compare clinical course across the three groups to see if the structured plan improves patient results in the general practice setting.

Why it matters

Who can join: the full rules

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.

Where it's running

• Aalborg University Hospital, Department of Psychiatry
  Aalborg, Denmark Recruiting

Study contacts

• Study coordinator: Sarah Bloch, MD and PhD student
• Email: s.bloch@rn.dk
• Phone: 0045 40196342

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.