Project Collabri. The Effect of a Collaborative Care Model for Treatment of Depression in Primary Care in Denmark - A Cluster Randomized Clinical Superiority Trial
Overview
- Phase
- N/A
- Intervention
- Treatment according to the Collabri model
- Conditions
- Depression
- Sponsor
- Amager Hospital
- Enrollment
- 325
- Locations
- 1
- Primary Endpoint
- Degree of depression measured by the Beck Depression Inventory (BDI)
- Status
- Completed
- Last Updated
- 2 months ago
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.
Investigators
Lene Falgaard Eplov
Head of Research, Associate professor
Amager Hospital
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.
Arms & Interventions
Treatment according to the Collabri model
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
Intervention: Treatment according to the Collabri model
Treatment as usual
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.
Outcomes
Primary Outcomes
Degree of depression measured by the Beck Depression Inventory (BDI)
Time Frame: At 6 months follow up after baseline
The measure is self-reported
Secondary Outcomes
- Degree of anxiety measured by the Beck Anxiety Inventory (BAI)(At 6 months follow up after baseline)
- Psychological stress measured with the Symptom Checklist (SCL-92)(At 6 months follow up after baseline)
- Functional impairment measured with the Global Assessment of Functioning (GAF-F split version)(At 6 months follow up after baseline)