Collabri Flex - Effect of Collaborative Care for People With Depression in General Practice (Collabri Flex)
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|ClinicalTrials.gov Identifier: NCT03113201|
Recruitment Status : Recruiting
First Posted : April 13, 2017
Last Update Posted : August 13, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Depression||Behavioral: Collaborative care Behavioral: Consultations-Liaison||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||240 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Projekt Collabri Flex - The Effect of a Danish Model for Collaborative Care for People With Depression in General Practice|
|Actual Study Start Date :||January 15, 2018|
|Estimated Primary Completion Date :||August 30, 2019|
|Estimated Study Completion Date :||December 31, 2019|
Experimental: Collabri Flex
Behavioral: 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
Consultations with general practitioner
Consultation-Liaison provided by general practitioner involving a educational relationship with the Collabri Flex team (care manager and psychiatrist).
- Self-reported degree of depression [ Time Frame: 6 months ]Measured by Beck Depression Inventory (BDI-II)
- Self-reported degree of anxiety [ Time Frame: 6 months ]Measured by Beck anxiety Inventory (BAI)
- Self-reported psychological stress [ Time Frame: 6 months ]Measured by Symptom Checklist (SCL-90-R)
- Self-reported functional impairment [ Time Frame: 6 months ]Measured by Sheehan disability Scale (SDS)
- Self-reported quality of life [ Time Frame: 6 months ]Measured by WHO-5
- Sick leave [ Time Frame: 6 months ]Obtained from the DREAM database
- Self-reported self-efficacy [ Time Frame: 6 monts ]Measured by personal control (IPQ-R scale) and two subscales from the Chronic Disease Self-Efficacy Scales (SECD-32); Obtain help from Comunity, Family, Friends Scale and Control/manage Depression Scale
- Self-reported health-related quality of life [ Time Frame: 6 months ]Measured by EQ-5D
- Self-reported experience of support in recovery [ Time Frame: 6 months ]Experience of support in recovery (INSPIRE)
- Employment [ Time Frame: 6 months ]Obtained from the DREAM database
- Mental-health outpatient services [ Time Frame: 6 months ]Obtained from LPR
- Patient satisfaction [ Time Frame: 6 months ]Self-reported experience of satisfaction with treatment (CSQ-8)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03113201
|Contact: Lene F Eplov, MD, PhD||+45 38647461||Lene.Falgaard.Eplov@regionh.dk|
|Contact: Nadja Kehler Curth, MScemail@example.com|
|Mental Health Centre Copenhagen||Recruiting|
|Contact: Lene F Eplov, MD, PhD 0045 38647461 firstname.lastname@example.org|
|Principal Investigator:||Lene F Eplov, MD, PhD||Research Unit, Mental Health Center Copenhagen|