Actively Recruiting
Improving Treatment for Depression in General Practice Using a Step-by-Step Care Plan.
Led by Aalborg University Hospital · Updated on 2025-12-10
171
Participants Needed
1
Research Sites
78 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Improving Treatment for Depression in General Practice Using a Step-by-Step Care Plan.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of unipolar depressive disorder confirmed by a general practitioner
- Moderate severity of depressive episode as judged by the general practitioner
- Clinical uncertainty about whether medication or psychotherapy is better for the patient
- Age between 18 and 65 years at the time of randomisation
- Patient is currently treated in general practice
- Ability to participate in virtual meetings (phone or computer) and have e-Boks
- Willingness to receive psychotherapy by a psychologist and/or medication
- Signed informed consent document
You will not qualify if you...
- Substance misuse that might affect the study, as judged by the investigator
- Difficulty understanding Danish language, as judged by the investigator
- Diagnosis of dementia
- Medical conditions that could interfere with study safety or outcomes, as judged by the investigator
- Pregnancy
- High risk of not following the study protocol, as judged by the investigator
- Recent suicidality (positive response to C-SSRS questions 4 or 5 in last 3 months) or as judged by investigator
- No current medical or psychotherapy treatment started within 4 weeks before screening
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Aalborg University Hospital, Department of Psychiatry
Aalborg, Denmark
Actively Recruiting
Research Team
S
Sarah Bloch, MD and PhD student
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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