The effect of specialised versus generalised outpatient treatment for bipolar disorder – the CAG Bipolar trial: study protocol for a randomized controlled trial
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 upon 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 out-patient treatment in CAG Bipolar versus generalised community-based treatment improves patient outcomes and clinician´s satisfaction with care in patients with bipolar disorder.
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 January 13th, 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.