双相情感障碍交互式心理教育（BIPED）研究：试验设计与方案
The Bipolar Interactive Psychoeducation (BIPED) study: trial design and protocol.
作者信息
Simpson Sharon, Barnes Emma, Griffiths Emily, Hood Kerry, Cohen David, Craddock Nick, Jones Ian, Smith Daniel J
机构信息
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.
出版信息
BMC Psychiatry. 2009 Aug 12;9:50. doi: 10.1186/1471-244X-9-50.
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/DESIGN: 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.
DISCUSSION
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.
TRIAL REGISTRATION
Current Controlled Trials ISRCTN81375447.
背景
双相情感障碍影响着3%至5%的人口，并伴有相当严重的终身功能损害。由于双相情感障碍相关的许多发病率是由反复出现的抑郁症状引起的，而这些症状通常对抗抑郁药反应不佳，因此需要开发替代性的非药物干预措施。心理教育干预已成为双相情感障碍有前景的长期治疗选择。
方法/设计：该研究是一项探索性的、个体随机对照试验。名为“战胜双相情感障碍”的干预措施是一个通过新型网络系统提供的心理教育项目。我们将招募100名目前处于临床缓解期、诊断为DSM-IV双相情感障碍（包括I型和II型）的患者。主要结局是生活质量。将参与心理教育项目的患者与接受常规治疗的患者进行比较。在干预后以及随机分组10个月后立即评估生活质量。次要结局包括当前的抑郁和躁狂症状、随访期间经历的抑郁和躁狂/轻躁狂发作次数、整体功能、功能损害和自知力。还将进行成本评估和过程评估，以探讨该干预措施的可行性和可接受性以及有效性的潜在障碍。
讨论
双相情感障碍很常见，未得到充分认识且管理往往不佳。它是一种慢性、终身、复发性疾病，对个人和经济都有巨大影响。该试验将首次探索一种新型基于网络的心理教育干预措施对双相情感障碍患者的有效性，这种干预措施有可能轻松推广到患者中。
试验注册
当前对照试验ISRCTN81375447。
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