A step-by-step care plan for depression treated by family doctors
Compares a structured treatment plan with usual care in adults with moderate depression.
Plain-language title generated from the registry record
Registry title: Improving Treatment for Depression in General Practice Using a Step-by-Step Care Plan.
Key facts
- Where
- Aalborg, DenmarkSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT07263321, who can take part
Where in Denmark
- Aalborg University Hospital, Department of PsychiatryAalborg, DenmarkTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Aalborg University Hospital
- Trial code
- NCT07263321
- Record updated
- 10 December 2025
- Original description
The goal of this clinical trial is to compare three different treatments for depression in patients with moderate depression in General Practice, aged 18-65 years.Read full original descriptionShow less
Optimising Treatment for Patients With Depressive Episodes in General Practice Through Algorithm-Based Treatment: A Randomised, Open-label Controlled Trial.
The goal of this clinical trial is to compare three different treatments for depression in patients with moderate depression in General Practice, aged 18-65 years.
We wish to investigate the effect of the treatment approaches, and 171 patients will be included in the trial. The participants will be randomised to one of the following three treatments:
1. Standard treatment provided by a general practitioner (i.e. the general practitioner treats the patient as he/she would normally do, when treating a patient with depression). 2. Standard treatment provided by a psychologist in the form behavioural therapy (i.e. the psychologist treats the patient as he/she would normally do, when treating a patient with depression). 3. A step-by-step treatment plan carried out by a general practitioner. The plan includes pre-determined follow-ups and a pre-determined, structured plan for which medications to use and when to increase dose or switch medication.
The hypothesis is that a structured and step-by-step treatment approach regarding patients with depression, treated in general practice, is more effective than standard treatment provided by a general practitioner and a psychologist.
All the participants will:
1. Receive one of the three treatments for 12 weeks. 2. Have meetings with the project staff every 4 weeks (week 0, 4, 8 and 12) were rating scales will be completed, e.g. a rating scale to measure progress or deterioration in the participant's depression.
Inclusion: The participant must be referred to the study with a diagnosis of unipolar depressive disorder, as judge by the GP; Severity of the depressive episode corresponding to moderate depression, as judged by the GP; Clinical uncertainty regarding which of the treatments, medication or psychotherapy, would be the better choice in the case concerned; Age criteria: Participants must be at least 18 years old and no more than 65 years old at the time of randomisation; The participant must be a patient in general practice; Participants must be able to participate in virtual meetings (e.g. by phone or computer) and have e-Boks; The participant must be willing to receive psychotherapy by a psychologist and/or medication; Must have signed the document of informed consent.
Exclusion: No current medical or psychotherapy treatment initiated within the last 4 weeks prior to screening; A diagnosis of dementia; Medical conditions that might interfere with the study outcome or safety, judged so by the investigator; Misuse of substances that might influence the study, as judged by the investigator; Difficulty in understanding the Danish language, as judged by the investigator; Pregnancy; High risk of non-adherence at the investigator's discretion; Suicidality: according to C-SSRS with a positive response to question 4 or 5 within the last three months or upon investigator's discretion.