Collabri Flex - Effect of Collaborative Care for People With Depression in General Practice

Study Overview
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Brief Summary
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The aim of the study Collabri Flex is to: Develop a Danish model for collaborative care for patients with depression in general practice, based on past experience gained in the Collabri Project. Examine the impact of this model compared with liaison-consultation for people with depression in a randomized controlled design from selected endpoints.

Detailed Description
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The Collabri Flex model for Collaborative Care takes point of departure in the earlier study Collabri. It is changed according to gathered information under the first study of the Collabri model in order to achieve a Danish Collaborative Care model easier to implement. The aims of Project Collabri Flex are to: Develop a flexible model for collaborative care (the Collabri Flex model) for patients with depression. Study the effects of this Collabri Flex model against consultation liaison in a randomized design on selected outcomes. In Collabri the treatment is in line with a set of general treatment principles relevant for collaborative care interventions. The patients in the intervention group are offered cognitive behavioral therapy (CBT), psychoeducation and medication according to a stepped care model by a care manager refering to the general practitioner. The Collabri Flex study is set up as a researcher-blinded individually randomized controlled trial with participation of an intervention group (treatment according to the Collabri Flex model) and a consultation liaison group. This study will contribute with new knowledge on collaborative care interventions in a Scandinavian context.

Official Title
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Projekt Collabri Flex - The Effect of a Danish Model for Collaborative Care for People With Depression in General Practice

Conditions
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Depression

Intervention / Treatment
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* Behavioral: Collaborative care
* Behavioral: Consultations-Liaison


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Danish speaking Diagnosis of current depression based on the Mini International Neuropsychiatric Interview (MINI) by care managers that have been trained in using MINI in close collaboration with the psychiatrist/psychologist. 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 the GP Psychotic condition detected in the MINI and/or by the GP Patients with a diagnosis of dementia Alcohol or substance misuse that hinders the person participating in Collabri treat-ment as assessed by the practitioner or care manager at inclusion interview If the patient has been referred or is recommended referral to secondary care treatment (mental health center) or psychiatrist in private practice Patients who are assessed by the GP as medically unstable making it impossible for the patient to adhere to treatment Bipolar affective disorder as assessed in the MINI and/or by the GP Pregnancy For patients in the Collabri Flex group: Patients with depression who wants treatment cf. the psychologist scheme (Psykologordningen) or similar treatment and do not want the refferal to the psychologist preceded by other treatment, cf. the Collabri Flex model assessed by the GP Patients that wish to continue current psychological or psychiatric treatment due to anxiety or depression

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Collabri Flex<br>Collaborative care | Behavioral: Collaborative care<br>* Collaborative care provided by the general practitioner and the care manager. Treatment modalities: Cognitive-behavior Therapy, psychoeducation and medication according to a stepped care model<br>|
| Experimental: Consultation-Liaison<br>Consultations with general practitioner | Behavioral: Consultations-Liaison<br>* Consultation-Liaison provided by general practitioner involving a educational relationship with the Collabri Flex team (care manager and psychiatrist).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported degree of depression | Measured by Beck Depression Inventory (BDI-II) | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported degree of anxiety | Measured by Beck anxiety Inventory (BAI) | 6 months | 
| Self-reported psychological stress | Measured by Symptom Checklist (SCL-90-R) | 6 months | 
| Self-reported functional impairment | Measured by Sheehan disability Scale (SDS) | 6 months | 
| Self-reported quality of life/well-being | Measured by WHO-5 | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depression, Collaborative care, Care manager, Anxiety, Psychiatry, Consultation-liaison, General practitioner