Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
NCT07263321

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

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Aalborg University Hospital, Department of Psychiatry

Aalborg, Denmark

Actively Recruiting

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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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