The Bipolar Interactive Psychoeducation (BIPED) study: trial design and protocol.
BACKGROUND
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.


METHODS
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.


CONCLUSIONS
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.


BACKGROUND
Current Controlled Trials ISRCTN81375447.
Simpson
Sharon
S
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. simpsonsa@cf.ac.uk
Barnes
Emma
E
Griffiths
Emily
E
Hood
Kerry
K
Cohen
David
D
Craddock
Nick
N
Jones
Ian
I
Smith
Daniel J
DJ
D000293:Adolescent; D000328:Adult; D000368:Aged; D001714:Bipolar Disorder / Q000175:diagnosis / Q000628:therapy*; D002985:Clinical Protocols; D003866:Depressive Disorder / Q000175:diagnosis / Q000628:therapy; D039721:Diagnostic and Statistical Manual of Mental Disorders; D005260:Female; D017144:Focus Groups; D005500:Follow-Up Studies; D006801:Humans; D020407:Internet / Q000706:statistics & numerical data; D008297:Male; D008875:Middle Aged; D017063:Outcome Assessment, Health Care; D010353:Patient Education as Topic / Q000379:methods*; D015397:Program Evaluation; D011569:Psychiatric Status Rating Scales; D011788:Quality of Life; D012107:Research Design; D016896:Treatment Outcome
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