Improving Treatment for Depression in General Practice Using a Step-by-Step Care Plan.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Algorithm-Based Treatment, Treatment as usual (TAU), Treatment as usual (TAU).
- Who it may be relevant to
- Registry conditions: Depressive Disorder, Depression - Major Depressive Disorder, Depressive Disorder, Major Depressive Disorder, Depressive Disorders. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Optimising Treatment for Patients With Depressive Episodes in General Practice Through Algorithm-Based Treatment: A Randomised, Open-label Controlled Trial.
Overview
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.
Interventions
- Other Algorithm-Based Treatment
This is an open-label pharmacological intervention. - 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. - 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.
Primary outcome measures
- The Hamilton Rating Scale for Depression, 6 item version (HAM-D6) [Time frame: From enrollment to the end of treatment at 12 weeks.]
Secondary outcome measures (5)
- The Columbia-Suicide Severity Rating Scale (C-SSRS) [Time frame: From enrollment to the end of treatment at 12 weeks.]
- The Major Depression Inventory (MDI) [Time frame: From enrollment to the end of treatment at 12 weeks.]
- The Personal and Social Performance Scale (PSP) [Time frame: From enrollment to the end of treatment at 12 weeks]
- The Danish Adult Reading Test (DART) [Time frame: At enrollment]
- The Brief INSPIRE-O [Time frame: At the end of the treatment at 12 weeks.]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Denmark · 1 center
- Aalborg University Hospital, Department of Psychiatry — Aalborg
Identifiers
NCT: NCT07263321 · N-20250019