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

Amager Hospital389 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

389

Conditions

Depression

Interventions

Collaborative careBEHAVIORAL

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

Consultations-LiaisonBEHAVIORAL

Consultation-Liaison provided by general practitioner involving a educational relationship with the Collabri Flex team (care manager and psychiatrist).

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Mental Health Centre Copenhagen

Copenhagen, Denmark

Outcomes

Primary Outcomes

Self-reported degree of depression

Measured by Beck Depression Inventory (BDI-II)

Time frame: 6 months

Secondary Outcomes

Self-reported degree of anxiety

Measured by Beck anxiety Inventory (BAI)

Time frame: 6 months

Self-reported psychological stress

Measured by Symptom Checklist (SCL-90-R)

Time frame: 6 months

Self-reported functional impairment

Measured by Sheehan disability Scale (SDS)

Time frame: 6 months

Self-reported quality of life/well-being

Measured by WHO-5

Time frame: 6 months

Data from ClinicalTrials.gov

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