Effect of specialised versus generalised outpatient treatment for bipolar disorder: the CAG Bipolar trial - study protocol for a randomised controlled trial

Lars Vedel Kessing, Natacha Blauenfeldt Kyster, Pernille Bondo-Kozuch, Ellen Margrethe Christensen, Birgitte Vejstrup, Birte Smidt, Anne-Marie Bangsgaard Jørgensen, Raben Rosenberg, Darius Mardosas, Louise Behrend Rasmussen, Maj Vinberg, Ida Hageman, Maria Faurholt-Jepsen, CAG Bipolar Study group, Kim Brøndmark, Signe Seidelin, Pernille Bondo-Kozuch, Ida Palmblad Sarauw-Nielsen, Annemette Larsen, Lars Vedel Kessing, Natacha Blauenfeldt Kyster, Pernille Bondo-Kozuch, Ellen Margrethe Christensen, Birgitte Vejstrup, Birte Smidt, Anne-Marie Bangsgaard Jørgensen, Raben Rosenberg, Darius Mardosas, Louise Behrend Rasmussen, Maj Vinberg, Ida Hageman, Maria Faurholt-Jepsen, CAG Bipolar Study group, Kim Brøndmark, Signe Seidelin, Pernille Bondo-Kozuch, Ida Palmblad Sarauw-Nielsen, Annemette Larsen

Abstract

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.

Keywords: adult psychiatry; depression & mood disorders; organisation of health services.

Conflict of interest statement

Competing interests: LVK has within the last 3 years been a consultant for Lundbeck and Teva. MV has within the last 3 years been a consultant for Lundbeck, Janssen/Cilag and Sunovion. All other authors have no conflicts of interest to declare.

© 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.

Figures

Figure 1
Figure 1
Flow diagram—the CAG Bipolar randomised controlled trial. CAG Bipolar, Clinical Academic Group for bipolar disorder; ICD-10, International Classification of Diseases, V.10.

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