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

NCT07263321 | Recruiting

• 1 other identifier: N-20250019
• Study Type: interventional
• Target: 171
• Locations: 1 country
• Sites: 1

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. 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. 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. 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.
4. 4.Receive one of the three treatments for 12 weeks.
5. 5.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

Keywords

Treatment for depressive disorder in General Practice; Algorithm-based treatment in General Practice; Algorithm-guided treatment in General Practice; Algorithm-based treatment for depression in General Practice; Algorithm-based treatment for depressive disorder in General Practice; Algorithm-based treatment for depressive episodes in General Practice; Algorithm-guided treatment for depressive episodes in General Practice; Optimising treatment for depressive episodes in general practice

Outcome Measures

Primary Outcomes (1)

• The Hamilton Rating Scale for Depression, 6 item version (HAM-D6)

  From enrollment to the end of treatment at 12 weeks.

Secondary Outcomes (5)

• The Columbia-Suicide Severity Rating Scale (C-SSRS)

  From enrollment to the end of treatment at 12 weeks.

• The Major Depression Inventory (MDI)

  From enrollment to the end of treatment at 12 weeks.

• The Personal and Social Performance Scale (PSP)

  From enrollment to the end of treatment at 12 weeks

• The Danish Adult Reading Test (DART)

  At enrollment

• The Brief INSPIRE-O

  At the end of the treatment at 12 weeks.

Study Arms (3)

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

OTHER

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.

Other: Treatment as usual (TAU)

Treatment as usual by a psychologist (TAU-P).

OTHER

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).

Other: Treatment as usual (TAU)

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

EXPERIMENTAL

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.

Other: Algorithm-Based Treatment

Interventions

Algorithm-Based Treatment OTHER

This is an open-label pharmacological intervention.

Also known as: ALGO, Algorithm-guided treatment, Algorithm treatment

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

Treatment as usual (TAU) 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.

Also known as: Treatment as usual by a general practitioner, TAU-GP

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The participant must be referred to the study with a diagnosis of unipolar depressive disorder, as judge by the GP.
• Severity of the depressive episode corresponding to moderate depression, as judged by the GP.
• Clinical uncertainty regarding which of the treatments, medication or psychotherapy, would be the better choice in the case concerned.
• Age criteria: Participants must be at least 18 years old and no more than 65 years old at the time of randomisation.
• The participant must be a patient in general practice.
• Participants must be able to participate in virtual meetings (e.g. by phone or computer) and have e-Boks.
• The participant must be willing to receive psychotherapy by a psychologist and/or medication.
• Must have signed the document of informed consent.

You may not qualify if:

• Misuse of substances that might influence the study, as judged by the investigator.
• Difficulty in understanding the Danish language, as judged by the investigator.
• A diagnosis of dementia.
• Medical conditions that might interfere with the study outcome or safety, judged so by the investigator.
• Pregnancy.
• High risk of non-adherence at the investigator's discretion.
• Suicidality: according to C-SSRS with a positive response to question 4 or 5 within the last three months or upon investigator's discretion.
• No current medical or psychotherapy treatment initiated within the last 4 weeks prior to screening.

Sponsors & Collaborators

• Aalborg University Hospital: lead

Study Sites (1)

Aalborg University Hospital, Department of Psychiatry

Aalborg, Denmark

RECRUITING

MeSH Terms

Conditions

Depressive Disorder; Depressive Disorder, Major; Depression

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Central Study Contacts

Sarah Bloch, MD and PhD student

CONTACT

0045 40196342; s.bloch@rn.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Professor and PhD.

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: December 4, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: December 10, 2025

Record last verified: 2025-11

Locations

DK (1)