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

Aalborg University Hospital

Status: Enrolling

Conditions: Depressive Disorders; Depressive Episode; Depression; Depressive Episodes; Depressive Disorder; Depressive Disorder, Major Depressive Disorder; Depression - Major Depressive Disorder

Treatments: Other: Algorithm-Based Treatment; Other: Treatment as usual (TAU)

Study type: Interventional

Funder types: Other

Identifiers

NCT07263321

N-20250019

Details and patient eligibility

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.

Enrollment: 171 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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171 participants in 3 patient groups

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

Other group

Description:

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.

Treatment:

Other: Treatment as usual (TAU)

Other: Treatment as usual (TAU)

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

Other group

Description:

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).

Treatment:

Other: Treatment as usual (TAU)

Other: Treatment as usual (TAU)

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

Experimental group

Description:

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.

Treatment:

Other: Algorithm-Based Treatment