title: The Bipolar Interactive Psychoeducation (BIPED) study: trial design and protocol.
abstract: 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.
authors.affiliation: 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
authors.forename: Sharon
authors.initials: S
authors.lastname: Simpson
authors.forename: Emma
authors.initials: E
authors.lastname: Barnes
authors.forename: Emily
authors.initials: E
authors.lastname: Griffiths
authors.forename: Kerry
authors.initials: K
authors.lastname: Hood
authors.forename: David
authors.initials: D
authors.lastname: Cohen
authors.forename: Nick
authors.initials: N
authors.lastname: Craddock
authors.forename: Ian
authors.initials: I
authors.lastname: Jones
authors.forename: Daniel J
authors.initials: DJ
authors.lastname: Smith
mesh_terms: 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
references.citation: Psychol Med. 1998 May;28(3):551-8
references.pmid: 9626712
references.citation: Bipolar Disord. 2004 Aug;6(4):294-8
references.pmid: 15225146
references.citation: Clin Pract Epidemiol Ment Health. 2007 Jun 07;3:5
references.pmid: 17555558
references.citation: Br J Psychiatry. 1978 Nov;133:429-35
references.pmid: 728692
references.citation: BMC Fam Pract. 2009 Mar 23;10:20
references.pmid: 19309493
references.citation: Bipolar Disord. 2003 Dec;5(6):421-33
references.pmid: 14636365
references.citation: Arch Gen Psychiatry. 2002 Jun;59(6):530-7
references.pmid: 12044195
references.citation: J Clin Psychiatry. 1998;59 Suppl 20:22-33;quiz 34-57
references.pmid: 9881538
references.citation: BMJ. 2007 Feb 17;334(7589):327
references.pmid: 17303845
references.citation: Br J Psychiatry. 2003 Oct;183:323-31
references.pmid: 14519610
references.citation: Br J Psychiatry. 2008 Jan;192(1):52-8
references.pmid: 18174510
references.citation: Arch Gen Psychiatry. 2003 Apr;60(4):402-7
references.pmid: 12695318
references.citation: Bipolar Disord. 2008 Jun;10(4):511-9
references.pmid: 18452447
references.citation: J Nerv Ment Dis. 2008 Jul;196(7):568-71
references.pmid: 18626298
references.citation: Arch Gen Psychiatry. 2003 Mar;60(3):261-9
references.pmid: 12622659
references.citation: Ann Med. 2001 Jul;33(5):337-43
references.pmid: 11491192
references.citation: Health Qual Life Outcomes. 2005 Nov 15;3:72
references.pmid: 16288650
references.citation: Eur Psychiatry. 2005 Aug;20(5-6):359-64
references.pmid: 16112848
references.citation: J Psychiatr Res. 2004 Nov-Dec;38(6):577-82
references.pmid: 15458853
references.citation: Br J Psychiatry. 2006 Apr;188:313-20
references.pmid: 16582056
references.citation: Bipolar Disord. 2005;7 Suppl 5:32-6
references.pmid: 16225558
references.citation: J Affect Disord. 2007 Feb;98(1-2):11-27
references.pmid: 16950516
references.citation: Am J Psychiatry. 2005 Feb;162(2):324-9
references.pmid: 15677598
references.citation: Arch Gen Psychiatry. 2003 Sep;60(9):904-12
references.pmid: 12963672
references.citation: Arch Gen Psychiatry. 2003 Feb;60(2):145-52
references.pmid: 12578431
references.citation: BMJ. 1999 Jan 16;318(7177):149-53
references.pmid: 9888904
references.citation: Biol Psychiatry. 2000 Sep 15;48(6):582-92
references.pmid: 11018229
references.citation: Qual Life Res. 2005 Feb;14(1):151-60
references.pmid: 15789949
references.citation: J Affect Disord. 2007 Jun;100(1-3):163-9
references.pmid: 17126913