Collabri Flex

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

389 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-15

Study Completion Date

2021-03-29

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.

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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.

Conditions

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Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Collaborative care

Group Type EXPERIMENTAL

Collaborative care

Intervention Type BEHAVIORAL

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

Consultation-Liaison

Consultations with general practitioner

Group Type EXPERIMENTAL

Consultations-Liaison

Intervention Type BEHAVIORAL

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

Interventions

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Collaborative care

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

Intervention Type BEHAVIORAL

Consultations-Liaison

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

Intervention Type BEHAVIORAL

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No