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

NCT ID: NCT07263321

Last Updated: 2025-12-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 171 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-31
• Study Completion Date: 2027-06-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment as usual by a general practitioner (TAU-GP).

The participants in this arm will receive "treatment as usual" (TAU), administered by a general practitioner (GP), i.e. the practitioner will implement a standard treatment (e.g. pharmacological) that he or she would normally use when treating a patient with depression in general practice.

Group Type: OTHER

Treatment as usual (TAU)

Intervention Type: OTHER

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 by a psychologist (TAU-P).

The participants in this arm will receive "treatment as usual", meaning a standard treatment in the form of Cognitive Behavioural Therapy (CBT) administered by a psychologist (P).

Group Type: OTHER

Treatment as usual (TAU)

Intervention Type: OTHER

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.

Algorithm-based pharmacological treatment by a general practitioner (ALGO).

In this arm the general practitioner designs a pharmacological, pre-determined and structured step-by-step care plan, including measurement-based care (e.g. Hamilton Rating Scale for Depression), critical decision points and follow ups at week 4, 8 and 12. At these decision points, rating scales are reviewed, and the score results will trigger the next action according to the pre-determined plan.

Group Type: EXPERIMENTAL

Algorithm-Based Treatment

Intervention Type: OTHER

This is an open-label pharmacological intervention.

Interventions

Algorithm-Based Treatment

This is an open-label pharmacological intervention.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: OTHER

Other Intervention Names

ALGO; Algorithm-guided treatment; Algorithm treatment; Treatment as usual by a general practitioner; TAU-GP; Treatment as usual by a psychologist; TAU-P

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aalborg University Hospital

OTHER

Sponsor Role: lead

Responsible Party

René Ernst Nielsen

MD, Professor and PhD.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Aalborg University Hospital, Department of Psychiatry

Aalborg, , Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Sarah Bloch, MD and PhD student

Role: CONTACT

s.bloch@rn.dk

0045 40196342

Facility Contacts

Sarah Bloch

Role: primary

s.bloch@rn.dk

0045 40196342

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

N-20250019

Identifier Type: -

Identifier Source: org_study_id