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Effect of specialised versus generalised outpatient treatment for bipolar disorder: the CAG Bipolar trial - study protocol for a randomised controlled trial
INTRODUCTION: Despite current available treatment patients with bipolar disorder often experience relapses and decreased overall functioning. Furthermore, patients with bipolar disorder are often not treated medically or psychologically according to guidelines and recommendations. A Clinical Academi...
Autores principales: | , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BMJ Publishing Group
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8515461/ https://www.ncbi.nlm.nih.gov/pubmed/34645661 http://dx.doi.org/10.1136/bmjopen-2021-048821 |
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author | Kessing, Lars Vedel Kyster, Natacha Blauenfeldt Bondo-Kozuch, Pernille Christensen, Ellen Margrethe Vejstrup, Birgitte Smidt, Birte Jørgensen, Anne-Marie Bangsgaard Rosenberg, Raben Mardosas, Darius Rasmussen, Louise Behrend Vinberg, Maj Hageman, Ida Faurholt-Jepsen, Maria |
author_facet | Kessing, Lars Vedel Kyster, Natacha Blauenfeldt Bondo-Kozuch, Pernille Christensen, Ellen Margrethe Vejstrup, Birgitte Smidt, Birte Jørgensen, Anne-Marie Bangsgaard Rosenberg, Raben Mardosas, Darius Rasmussen, Louise Behrend Vinberg, Maj Hageman, Ida Faurholt-Jepsen, Maria |
author_sort | Kessing, Lars Vedel |
collection | PubMed |
description | INTRODUCTION: Despite current available treatment patients with bipolar disorder often experience relapses and decreased overall functioning. Furthermore, patients with bipolar disorder are often not treated medically or psychologically according to guidelines and recommendations. A Clinical Academic Group is a new treatment initiative bringing together clinical services, research, education and training to offer care and treatment that is based on reliable evidence backed up by research. The present Clinical Academic Group for bipolar disorder (the CAG Bipolar) randomised controlled trial (RCT) aims for the first time to investigate whether specialised outpatient treatment in CAG Bipolar versus generalised community-based treatment improves patient outcomes and clinician’s satisfaction with care in patients with bipolar disorder. METHODS AND ANALYSIS: The CAG Bipolar trial is a pragmatic randomised controlled parallel-group trial undertaken in the Capital Region of Denmark covering a catchment area of 1.85 million people. Patients with bipolar disorder are invited to participate as part of their outpatient treatment in the Mental Health Services. The included patients will be randomised to (1) specialised outpatient treatment in the CAG Bipolar (intervention group) or (2) generalised community-based outpatient treatment (control group). The trial started 13 January 2020 and has currently included more than 600 patients. The outcomes are (1) psychiatric hospitalisations and cumulated number and duration of psychiatric hospitalisations (primary), and (2) self-rated depressive symptoms, self-rated manic symptoms, quality of life, perceived stress, satisfaction with care, use of medication and the clinicians’ satisfaction with their care (secondary). A total of 1000 patients with bipolar disorder will be included. ETHICS AND DISSEMINATION: The CAG Bipolar RCT is funded by the Capital Region of Denmark and ethical approval has been obtained from the Regional Ethical Committee in The Capital Region of Denmark (H-19067248). Results will be published in peer-reviewed academic journals, presented at scientific meetings and disseminated to patient organisations and media outlets. TRIAL REGISTRATION NUMBER: NCT04229875. |
format | Online Article Text |
id | pubmed-8515461 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | BMJ Publishing Group |
record_format | MEDLINE/PubMed |
spelling | pubmed-85154612021-10-27 Effect of specialised versus generalised outpatient treatment for bipolar disorder: the CAG Bipolar trial - study protocol for a randomised controlled trial Kessing, Lars Vedel Kyster, Natacha Blauenfeldt Bondo-Kozuch, Pernille Christensen, Ellen Margrethe Vejstrup, Birgitte Smidt, Birte Jørgensen, Anne-Marie Bangsgaard Rosenberg, Raben Mardosas, Darius Rasmussen, Louise Behrend Vinberg, Maj Hageman, Ida Faurholt-Jepsen, Maria BMJ Open Mental Health INTRODUCTION: Despite current available treatment patients with bipolar disorder often experience relapses and decreased overall functioning. Furthermore, patients with bipolar disorder are often not treated medically or psychologically according to guidelines and recommendations. A Clinical Academic Group is a new treatment initiative bringing together clinical services, research, education and training to offer care and treatment that is based on reliable evidence backed up by research. The present Clinical Academic Group for bipolar disorder (the CAG Bipolar) randomised controlled trial (RCT) aims for the first time to investigate whether specialised outpatient treatment in CAG Bipolar versus generalised community-based treatment improves patient outcomes and clinician’s satisfaction with care in patients with bipolar disorder. METHODS AND ANALYSIS: The CAG Bipolar trial is a pragmatic randomised controlled parallel-group trial undertaken in the Capital Region of Denmark covering a catchment area of 1.85 million people. Patients with bipolar disorder are invited to participate as part of their outpatient treatment in the Mental Health Services. The included patients will be randomised to (1) specialised outpatient treatment in the CAG Bipolar (intervention group) or (2) generalised community-based outpatient treatment (control group). The trial started 13 January 2020 and has currently included more than 600 patients. The outcomes are (1) psychiatric hospitalisations and cumulated number and duration of psychiatric hospitalisations (primary), and (2) self-rated depressive symptoms, self-rated manic symptoms, quality of life, perceived stress, satisfaction with care, use of medication and the clinicians’ satisfaction with their care (secondary). A total of 1000 patients with bipolar disorder will be included. ETHICS AND DISSEMINATION: The CAG Bipolar RCT is funded by the Capital Region of Denmark and ethical approval has been obtained from the Regional Ethical Committee in The Capital Region of Denmark (H-19067248). Results will be published in peer-reviewed academic journals, presented at scientific meetings and disseminated to patient organisations and media outlets. TRIAL REGISTRATION NUMBER: NCT04229875. BMJ Publishing Group 2021-10-13 /pmc/articles/PMC8515461/ /pubmed/34645661 http://dx.doi.org/10.1136/bmjopen-2021-048821 Text en © Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. https://creativecommons.org/licenses/by-nc/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) . |
spellingShingle | Mental Health Kessing, Lars Vedel Kyster, Natacha Blauenfeldt Bondo-Kozuch, Pernille Christensen, Ellen Margrethe Vejstrup, Birgitte Smidt, Birte Jørgensen, Anne-Marie Bangsgaard Rosenberg, Raben Mardosas, Darius Rasmussen, Louise Behrend Vinberg, Maj Hageman, Ida Faurholt-Jepsen, Maria Effect of specialised versus generalised outpatient treatment for bipolar disorder: the CAG Bipolar trial - study protocol for a randomised controlled trial |
title | Effect of specialised versus generalised outpatient treatment for bipolar disorder: the CAG Bipolar trial - study protocol for a randomised controlled trial |
title_full | Effect of specialised versus generalised outpatient treatment for bipolar disorder: the CAG Bipolar trial - study protocol for a randomised controlled trial |
title_fullStr | Effect of specialised versus generalised outpatient treatment for bipolar disorder: the CAG Bipolar trial - study protocol for a randomised controlled trial |
title_full_unstemmed | Effect of specialised versus generalised outpatient treatment for bipolar disorder: the CAG Bipolar trial - study protocol for a randomised controlled trial |
title_short | Effect of specialised versus generalised outpatient treatment for bipolar disorder: the CAG Bipolar trial - study protocol for a randomised controlled trial |
title_sort | effect of specialised versus generalised outpatient treatment for bipolar disorder: the cag bipolar trial - study protocol for a randomised controlled trial |
topic | Mental Health |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8515461/ https://www.ncbi.nlm.nih.gov/pubmed/34645661 http://dx.doi.org/10.1136/bmjopen-2021-048821 |
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