NCT07263321

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.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 171 (estimated)
• Sponsor: Aalborg University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
OTHER	Algorithm-Based Treatment	This is an open-label pharmacological intervention.
OTHER	Treatment 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.
OTHER	Treatment 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.

Timeline

• Start date: 2025-12-01
• Primary completion: 2027-06-01
• Completion: 2027-06-01
• First posted: 2025-12-04
• Last updated: 2025-12-10

Locations

1 site across 1 country: Denmark