Project Collabri for Treatment of Depression

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether treatment of patients with depression according to the Collabri Model is more effective in reducing symptoms compared to treatment as usual (TAU)

Detailed Description
-----------------
Background: Depression is a common disease mostly treated in general practice. Diagnose and evidence based treatment in general practice today is not optimal (e.g. lack of continuity in disease management and lack of treatment opportunities). International studies show effect of collaborative care on depression, but is not directly applicable into a Danish context. A Danish model for collaborative care treatment of people with depression, generalized anxiety disorder, social phobia and panic disorder (the Collabri Model) is developed. The Collabri model consists of a multi-professional approach to treatment, scheduled monitoring and review, enhanced inter-professional communication and a structured treatment plan. Objectives: to investigate the effect of the Collabri model for depression and further investigate two methods for detection of depression; standard detection and case finding. Methods: Two researcher-blinded cluster-randomized controlled studies with an intervention group (treatment according to the Collabri model) and a control group (TAU). Participants are 480 patients with depression consulting their general practitioner. Results: Primary outcome for the collaborative care study on depression is depression symptoms, measured with BDI at 6 months. Discussion: The results will contribute new knowledge on collaborative care for depression and anxiety in Danish conditions.

Official Title
-----------------
Project Collabri. The Effect of a Collaborative Care Model for Treatment of Depression in Primary Care in Denmark - A Cluster Randomized Clinical Superiority Trial

Conditions
-----------------
Depression

Intervention / Treatment
-----------------
* Other: Treatment according to the Collabri model


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age: 18+ years Danish speaking Diagnosis of current depression using the Mini International Neuropsychiatric Interview (MINI) (DSM IV) by researchers that have been trained in using MINI and according to the ICD-10 criteria or when diagnosed by GP after conference with a psychiatrist in Project Collabri The patient has given her/his written informed consent to participate in the trial at the described terms Exclusion Criteria: High risk of suicide assessed in the Mini International Neuropsychiatric Interview (MINI) and/or by general practitioner Psychotic condition detected in the MINI and/or by general practitioner Patients with a diagnosis of dementia Pregnancy Alcohol or substance misuse that hinders the person participating in Collabri treatment as assessed by the practitioner or researcher at inclusion interview Patients that are in current psychological or psychiatric treatment due to anxiety or depression Patients with a pending disability pension case Patients who have been treated for anxiety or depression within the last 6 months For patients in the intervention group: Patients with depression who wants treatment cf. the Danish psychologist scheme and do not want the reference to the psychologist preceded by other treatment, cf. the Collabri model For patients in the intervention group: If the patient at the first point of contact with the general practitioner after inclusion by a research assistant is referred to treatment as a part of the secondary psychiatric care system. Patients who are assessed by the general practitioner as medically unstable making it impossible for the patient to adhere to treatment OCD, PTSD, bipolar affective disorder as assessed in the MINI and/or by the general practitioner

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment according to the Collabri model<br>Participants in this group will recive treatment according to the Collabri model which is a Danish model for collaborative care between primary and secondary care for depression, social phobia, generalized anxiety and panic disorder | Other: Treatment according to the Collabri model<br>* The Collabri Model is a complex intervention and consists of a number of treatment modalities. The Collabri Model includes the following elements: A multi-professional approach to treatment including a care manager, scheduled monitoring and review, enhanced inter-professional communication and a structured treatment plan. It further integrates: Recruitment of staff with psychiatric experience, training of general practitioner and care manager, use of instruments for detection and follow-up, education and treatment of the patient, supervision from a psychiatric specialist, guided self-help, patient- and relative involvement and a stepped care approach to treatment where treatment is always commenced on the least invasive and least resource-demanding level.<br>|
| No Intervention: Treatment as usual<br>Control group. Participants in this group will recive treatment as usual. This means that participants will recive treatment corresponding to what their GP normally would offer as treatment. E.g. this could be refferal to a psychologist or psychiatrist and/or medicine. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Degree of depression measured by the Beck Depression Inventory (BDI) | The measure is self-reported | At 6 months follow up after baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Degree of anxiety measured by the Beck Anxiety Inventory (BAI) | The measure is self-reported | At 6 months follow up after baseline | 
| Psychological stress measured with the Symptom Checklist (SCL-92) | The measure is self-reported | At 6 months follow up after baseline | 
| Functional impairment measured with the Global Assessment of Functioning (GAF-F split version) | The measure is obtained through a semi-structured interview | At 6 months follow up after baseline |