Overview
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:
- 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).
- 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).
- 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:
- Receive one of the three treatments for 12 weeks.
- 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.
Eligibility
Inclusion Criteria:
- 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 Criteria:
- Misuse of substances that might influence the study, as judged by the investigator.
- Difficulty in understanding the Danish language, as judged by the investigator.
- A diagnosis of dementia.
- Medical conditions that might interfere with the study outcome or safety, judged so 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.
- No current medical or psychotherapy treatment initiated within the last 4 weeks prior to screening.