The Bipolar Interactive Psychoeducation (BIPED) study: trial design and protocol
1 South East Wales Trials Unit, Department of Primary Care and Public Health, 7thfloor Neuadd Merionnydd, School of Medicine, Cardiff University, Heath Park, Cardiff, UK, CF14 4XN
2 Department of Psychological Medicine, Cardiff University School of Medicine, Monmouth House, Heath Park, Cardiff, UK, CF14 4DW
3 Health Economics and Policy Research Unit, University of Glamorgan, Pontypridd, UK, CF37 1DL
BMC Psychiatry 2009, 9:50 doi:10.1186/1471-244X-9-50Published: 12 August 2009
Bipolar disorders affect between 3–5% of the population and are associated with considerable lifelong impairment. Since much of the morbidity associated with bipolar disorder is caused by recurrent depressive symptoms, which are often only poorly responsive to antidepressants, there is a need to develop alternative, non-pharmacological interventions. Psychoeducational interventions have emerged as promising long-term therapeutic options for bipolar disorder.
The study is an exploratory, individually randomised controlled trial. The intervention known as 'Beating Bipolar' is a psychoeducational programme which is delivered via a novel web-based system. We will recruit 100 patients with a diagnosis of DSM-IV bipolar disorder (including type I and type II) currently in clinical remission. The primary outcome is quality of life. This will be compared for those patients who have participated in the psychoeducational programme with those who received treatment as usual. Quality of life will be assessed immediately following the intervention as well as 10 months after randomisation. Secondary outcomes include current depressive and manic symptoms, number of episodes of depression and mania/hypomania experienced during the follow-up period, global functioning, functional impairment and insight. An assessment of costs and a process evaluation will also be conducted which will explore the feasibility and acceptability of the intervention as well as potential barriers to effectiveness.
Bipolar disorder is common, under-recognised and often poorly managed. It is a chronic, life-long, relapsing condition which has an enormous impact on the individual and the economy. This trial will be the first to explore the effectiveness of a novel web-based psychoeducational intervention for patients with bipolar disorder which has potential to be easily rolled out to patients.
Current Controlled Trials ISRCTN81375447