RecruitingNot ApplicableNCT07263321

Improving Treatment for Depression in General Practice Using a Step-by-Step Care Plan.

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

Sponsor

Aalborg University Hospital

Enrollment

171 participants

Start Date

Dec 1, 2025

Study Type

INTERVENTIONAL

Conditions

Depression Depressive Disorder Depression - Major Depressive Disorder Depressive Disorder, Major Depressive Disorder Depressive Episode Depressive Disorders Depressive Episodes

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing antidepressant medication versus psychotherapy as treatments for moderate depression diagnosed in a general practice (GP) setting, to help doctors and patients make better-informed choices about which treatment is right for a given individual. **You may be eligible if...** - You are between 18 and 65 years old - You have been referred to the study with a diagnosis of moderate unipolar depression by your GP - Your GP is clinically uncertain whether medication or therapy would be the better choice for you - You are a patient at a general practice and can participate in treatment sessions **You may NOT be eligible if...** - You have severe or very mild depression - You have bipolar disorder or psychosis - You are already receiving treatment that has been decided as the clear best option - You are under 18 or over 65 Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERAlgorithm-Based Treatment

This is an open-label pharmacological intervention.

OTHERTreatment as usual (TAU)

This is a "treatment as usual" provided by a general practitioner (GP). The GP will implement a standard treatment he or she normally would use, when treating a patient with moderate depression in general practice.

OTHERTreatment as usual (TAU)

This is a "treatment as usual" provided by a psychologist (P). The psychologist will implement Cognitive Behavioural Therapy as the standard treatment, since this is a widely used and recognised treatment strategy for patients with depression.