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Collaborative care vs consultation liaison for depression and anxiety disorders in general practice: study protocol for two randomized controlled trials (the Danish Collabri Flex trials)

BACKGROUND: Models of collaborative care and consultation liaison propose organizational changes to improve the quality of care for people with common mental disorders, such as anxiety and depression. Some literature suggests only short-term positive effects of consultation liaison on patient-relate...

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Autores principales: Curth, Nadja Kehler, Brinck-Claussen, Ursula, Jørgensen, Kirstine Bro, Rosendal, Susanne, Hjorthøj, Carsten, Nordentoft, Merete, Eplov, Lene Falgaard
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6814969/
https://www.ncbi.nlm.nih.gov/pubmed/31653228
http://dx.doi.org/10.1186/s13063-019-3657-0
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author Curth, Nadja Kehler
Brinck-Claussen, Ursula
Jørgensen, Kirstine Bro
Rosendal, Susanne
Hjorthøj, Carsten
Nordentoft, Merete
Eplov, Lene Falgaard
author_facet Curth, Nadja Kehler
Brinck-Claussen, Ursula
Jørgensen, Kirstine Bro
Rosendal, Susanne
Hjorthøj, Carsten
Nordentoft, Merete
Eplov, Lene Falgaard
author_sort Curth, Nadja Kehler
collection PubMed
description BACKGROUND: Models of collaborative care and consultation liaison propose organizational changes to improve the quality of care for people with common mental disorders, such as anxiety and depression. Some literature suggests only short-term positive effects of consultation liaison on patient-related outcomes, whereas collaborative care demonstrates both short-term and long-term positive effects. To our knowledge, only one randomized trial has compared the effects of these models. Collaborative care was superior to consultation liaison in reducing symptoms of depression for up to 3 months, but the authors found no difference at 9-months' follow-up. The Collabri Flex Trial for Depression and the Collabri Flex Trial for Anxiety aim to compare the effects of collaborative care with those of a form of consultation liaison that contains potential contaminating elements from collaborative care. The trials build on knowledge from the previous cluster-randomized Collabri trials. METHODS: Two randomized, investigator-initiated, parallel-group, superiority trials have been established: one investigating the effects of collaborative care vs consultation liaison for depression and one investigating the effects of collaborative care vs consultation liaison for generalized anxiety, panic disorder and social anxiety disorder at 6-months' follow-up. Participants are recruited from general practices in the Capital Region of Denmark: 240 in the depression trial and 284 in the anxiety trial. The primary outcome is self-reported depression symptoms (Beck Depression Inventory (BDI-II)) in the depression trial and self-reported anxiety symptoms (Beck Anxiety Inventory (BAI)) in the anxiety trial. In both trials, the self-reported secondary outcomes are general psychological problems and symptoms (Symptom Checklist 90-Revised), functional impairment (Sheehan Disability Scale) and general well-being (World Health Organization-Five Well-Being Index). In the depression trial, BAI is an additional secondary outcome, and BDI-II is an additional secondary outcome in the anxiety trial. Explorative outcomes will also be collected. DISCUSSION: The results will supplement those of the cluster-randomized Collabri trials and provide pivotal information about the effects of collaborative care in Denmark. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03113175 and NCT03113201. Registered on 13 April 2017. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s13063-019-3657-0) contains supplementary material, which is available to authorized users.
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spelling pubmed-68149692019-10-31 Collaborative care vs consultation liaison for depression and anxiety disorders in general practice: study protocol for two randomized controlled trials (the Danish Collabri Flex trials) Curth, Nadja Kehler Brinck-Claussen, Ursula Jørgensen, Kirstine Bro Rosendal, Susanne Hjorthøj, Carsten Nordentoft, Merete Eplov, Lene Falgaard Trials Study Protocol BACKGROUND: Models of collaborative care and consultation liaison propose organizational changes to improve the quality of care for people with common mental disorders, such as anxiety and depression. Some literature suggests only short-term positive effects of consultation liaison on patient-related outcomes, whereas collaborative care demonstrates both short-term and long-term positive effects. To our knowledge, only one randomized trial has compared the effects of these models. Collaborative care was superior to consultation liaison in reducing symptoms of depression for up to 3 months, but the authors found no difference at 9-months' follow-up. The Collabri Flex Trial for Depression and the Collabri Flex Trial for Anxiety aim to compare the effects of collaborative care with those of a form of consultation liaison that contains potential contaminating elements from collaborative care. The trials build on knowledge from the previous cluster-randomized Collabri trials. METHODS: Two randomized, investigator-initiated, parallel-group, superiority trials have been established: one investigating the effects of collaborative care vs consultation liaison for depression and one investigating the effects of collaborative care vs consultation liaison for generalized anxiety, panic disorder and social anxiety disorder at 6-months' follow-up. Participants are recruited from general practices in the Capital Region of Denmark: 240 in the depression trial and 284 in the anxiety trial. The primary outcome is self-reported depression symptoms (Beck Depression Inventory (BDI-II)) in the depression trial and self-reported anxiety symptoms (Beck Anxiety Inventory (BAI)) in the anxiety trial. In both trials, the self-reported secondary outcomes are general psychological problems and symptoms (Symptom Checklist 90-Revised), functional impairment (Sheehan Disability Scale) and general well-being (World Health Organization-Five Well-Being Index). In the depression trial, BAI is an additional secondary outcome, and BDI-II is an additional secondary outcome in the anxiety trial. Explorative outcomes will also be collected. DISCUSSION: The results will supplement those of the cluster-randomized Collabri trials and provide pivotal information about the effects of collaborative care in Denmark. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03113175 and NCT03113201. Registered on 13 April 2017. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s13063-019-3657-0) contains supplementary material, which is available to authorized users. BioMed Central 2019-10-25 /pmc/articles/PMC6814969/ /pubmed/31653228 http://dx.doi.org/10.1186/s13063-019-3657-0 Text en © The Author(s). 2019 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Study Protocol
Curth, Nadja Kehler
Brinck-Claussen, Ursula
Jørgensen, Kirstine Bro
Rosendal, Susanne
Hjorthøj, Carsten
Nordentoft, Merete
Eplov, Lene Falgaard
Collaborative care vs consultation liaison for depression and anxiety disorders in general practice: study protocol for two randomized controlled trials (the Danish Collabri Flex trials)
title Collaborative care vs consultation liaison for depression and anxiety disorders in general practice: study protocol for two randomized controlled trials (the Danish Collabri Flex trials)
title_full Collaborative care vs consultation liaison for depression and anxiety disorders in general practice: study protocol for two randomized controlled trials (the Danish Collabri Flex trials)
title_fullStr Collaborative care vs consultation liaison for depression and anxiety disorders in general practice: study protocol for two randomized controlled trials (the Danish Collabri Flex trials)
title_full_unstemmed Collaborative care vs consultation liaison for depression and anxiety disorders in general practice: study protocol for two randomized controlled trials (the Danish Collabri Flex trials)
title_short Collaborative care vs consultation liaison for depression and anxiety disorders in general practice: study protocol for two randomized controlled trials (the Danish Collabri Flex trials)
title_sort collaborative care vs consultation liaison for depression and anxiety disorders in general practice: study protocol for two randomized controlled trials (the danish collabri flex trials)
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6814969/
https://www.ncbi.nlm.nih.gov/pubmed/31653228
http://dx.doi.org/10.1186/s13063-019-3657-0
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