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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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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). |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Algorithm-Based Treatment | Other | This is an open-label pharmacological intervention. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Hamilton Rating Scale for Depression, 6 item version (HAM-D6) | From enrollment to the end of treatment at 12 weeks. |
| Measure | Description | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sarah Bloch, MD and PhD student | Contact | 0045 40196342 | s.bloch@rn.dk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aalborg University Hospital, Department of Psychiatry | Recruiting | Aalborg | Denmark |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 10, 2025 | Nov 6, 2025 |
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| 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. |
|
|
| Treatment as usual (TAU) | 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. |
|
|
| 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. |
| Prot_000.pdf |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D003865 | Depressive Disorder, Major |
| D003863 | Depression |
| ID | Term |
|---|---|
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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