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

Optimising Treatment for Patients With Depressive Episodes in General Practice Through Algorithm-Based Treatment: A Randomised, Open-label Controlled Trial.

It tests whether a structured step-by-step care plan used by general practitioners works better than usual GP care or psychologist-led behavioral therapy for adults 18–65 with moderate depression.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 171 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Aalborg University Hospital (Academic / other)
• Locations: 1 site (Aalborg)
• Trial ID: NCT07263321 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults aged 18–65 with a GP-diagnosed unipolar depressive disorder of moderate severity, who are patients in general practice, face clinical uncertainty about medication versus psychotherapy, can participate in virtual visits and use e-Boks, and are willing to accept psychotherapy and/or medication, are ideal candidates.

Not a fit: Patients with severe depression, active substance misuse, significant Danish language barriers, those outside the 18–65 age range, or not managed in general practice are unlikely to benefit from this specific trial approach.

Why it matters

Potential benefit: If successful, the step-by-step plan could give GPs a clear treatment roadmap that leads to faster symptom improvement and more consistent care for patients with moderate depression.

How similar studies have performed: Related stepped-care and algorithm-guided approaches in primary care and collaborative-care programs have shown modest to meaningful benefit in some studies, but results vary and this exact protocol in Danish general practice is being specifically tested.

Eligibility criteria

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 this trial is running

Aalborg

• Aalborg University Hospital, Department of Psychiatry — Aalborg, Denmark (Recruiting)

Study contacts

• Study coordinator: Sarah Bloch, MD and PhD student

Conditions Depressive Disorder; Depression - Major Depressive Disorder; Depressive Disorder, Major Depressive Disorder; Depressive Disorders; Depression; Depressive Episodes; Depressive Episode; Treatment for depressive disorder in General Practice