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

NCT07263321 · tracked via the Priya Life Science Denmark tracker

Sponsor

Aalborg University Hospital

Phase

Not applicable

Started

2025-12

Last updated

2025-12-10

Condition(s) studied

Depressive DisorderDepression - Major Depressive DisorderDepressive Disorder, Major Depressive DisorderDepressive DisordersDepressionDepressive EpisodesDepressive Episode

Investigational drug(s) / intervention(s)

Algorithm-Based TreatmentTreatment as usual (TAU)Treatment as usual (TAU)

Algorithm-Based Treatment: This is an open-label pharmacological intervention.

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.

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.

Study 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

Sex

ALL

Min age

18 Years

Max age

65 Years

Healthy volunteers

Inclusion Criteria: 1. The participant must be referred to the study with a diagnosis of unipolar depressive disorder, as judge by the GP. 2. Severity of the depressive episode corresponding to moderate depression, as judged by the GP. 3. Clinical uncertainty regarding which of the treatments, medication or psychotherapy, would be the better choice in the case concerned. 4. Age criteria: Participants must be at least 18 years old and no more than 65 years old at the time of randomisation. 5. The participant must be a patient in general practice. 6. Participants must be able to participate in virtual meetings (e.g. by phone or computer) and have e-Boks. 7. The participant must be willing to receive psychotherapy by a psychologist and/or medication. 8. Must have signed the document of informed consent. Exclusion Criteria: 1. Misuse of substances that might influence the study, as judged by the investigator. 2. Difficulty in understanding the Danish language, as judged by the investigator. 3. A diagnosis of dementia. 4. Medical conditions that might interfere with the study outcome or safety, judged so by the investigator. 5. Pregnancy. 6. High risk of non-adherence at the investigator's discretion. 7. Suicidality: according to C-SSRS with a positive response to question 4 or 5 within the last three months or upon investigator's discretion. 8. No current medical or psychotherapy treatment initiated within the last 4 weeks prior to screening.

Primary outcome measure(s)

The Hamilton Rating Scale for Depression, 6 item version (HAM-D6) — From enrollment to the end of treatment at 12 weeks.

Trial sites (1)

Facility	City	Region	Status
Aalborg University Hospital, Department of Psychiatry	Aalborg	Denmark	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07263321 on ClinicalTrials.gov ↗ ← All trials in Denmark