Depression, Depression - Major Depressive Disorder, Depressive Disorder, Depressive Disorder, Major Depressive Disorder, Depressive Disorders, Depressive Episode, Depressive Episodes
Conditions
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
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.
Interventions
OTHERAlgorithm-Based Treatment
This is an open-label pharmacological intervention.
OTHERTreatment 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.
Sponsors
Aalborg University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Hamilton Rating Scale for Depression, 6 item version (HAM-D6) | From enrollment to the end of treatment at 12 weeks. |
Secondary
| Measure | Time frame |
|---|---|
| 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. |
Countries
Denmark
Contacts
Primary ContactSarah Bloch, MD and PhD student
Outcome results
None listed