2/2-A Randomized Trial of Internet-Based Interventions for Bipolar Disorder

描述(申请人提供)：心理社会治疗是双相情感障碍患者的有效辅助治疗。利用互联网平台为精神障碍提供教育和支持的情况越来越普遍，但关于此类项目的好处的系统研究有限。基于互联网的干预措施有可能以即时访问、最低成本、方便和灵活的方式提供无限的支持资源。Moodswings 2.0是对双相情感障碍患者的基于互联网的干预的下一代发展(www.moodswings.net.au)，它基于经过验证的面对面干预，即MAP项目，其中包括CBT、IPSTRT、心理教育、动机访谈、解决问题、目标设定、早期预警迹象和复发预防计划等心理社会干预要素。Moodswings 2.0的模块包括症状和障碍信息，以及一个异步主持的同行讨论板。该计划包括许多交互式工具，以优化模块内容的理解和保留。Moodswings 2.0代表了对早期测试版的重大改进，改进了平台，增加了用户导航和交互工具，并增加了旨在促进与节目内容的兴趣和互动的附加功能。该计划的目的不是为双相情感障碍患者提供初级护理。这项拟议的研究包括修订Moodswings 2.0，以及对其在双相情感障碍患者中的使用和益处进行为期12个月的评估。我们提出了两点三臂随机平行小组阶梯式设计(只接触主持同伴讨论板，讨论板加心理教育，或讨论板，心理教育，和在线互动心理社会工具)。合作网站(加利福尼亚州帕洛阿尔托和澳大利亚墨尔本)将招募300名患有SCID确认的双相情感障碍I、II或NOS诊断的参与者。与研究人员的互动将通过电话采访和电子邮件通信进行，因为参与者将从任何地理位置招募，前提是符合双相情感障碍诊断、21-65岁、计算机接入和当地医疗保健(包括过去一年至少两次提供者就诊)和当地紧急护理的纳入标准。排除仅限于目前的躁狂或精神病症状。使用在线Moodswings 2.0程序是自愿的，该程序捕获12个月来在每个内容领域花费的时间作为感兴趣的结果。每季度评估一次成绩，方法是与不了解小组任务的评分员进行电话采访，以及在线自我报告。主要结果是抑郁症状在12个月内的变化，评估改善的三个组成部分(教育、讨论板和互动心理社会工具)是否有额外的好处。研究目标包括情绪高涨的症状、卫生服务的利用、复发的证据(干预时间)、功能、生活质量和服药依从性。

DESCRIPTION (provided by applicant): Psychosocial treatments are efficacious adjunctive treatments for persons with bipolar disorder. The use of internet platforms to deliver education and support for psychiatric disorders is increasingly common, but there is limited systematic research on the benefits of such programs. Internet based interventions have the potential to offer unlimited supportive resources with immediate access, minimal cost, convenience and flexibility. MoodSwings 2.0 is the next evolution of an internet-based intervention for individuals with bipolar disorder (www.moodswings.net.au), and is based on a validated face-to-face intervention, the MAPS project, which includes elements of psychosocial interventions including CBT, IPSTRT, psychoeducation, motivational interviewing, problem solving, goal setting, early warning signs and relapse prevention plans. Modules of MoodSwings 2.0 include symptom and disorder information as well as an asynchronous moderated peer discussion board. The program includes many interactive tools to optimize comprehension and retention of module content. MoodSwings 2.0 represents a significant improvement to earlier beta tested versions, with an improved platform, increased user navigation and interactive tools, and additional features designed to facilitate greater interest and interaction with program content. The program is not intended to serve as primary care for individuals with bipolar disorders. The proposed study includes the revision of MoodSwings 2.0, and a 12-month assessment of its use and benefits in patients with bipolar disorder. We propose a 2-site, 3-arm randomized parallel group stepped design (exposure to moderated peer discussion board only, discussion board plus psychoeducation, or discussion board, psychoeducation, and online interactive psychosocial tools). The collaborative sites (Palo Alto, CA and Melbourne, Australia) will enroll 300 participants with SCID-confirmed diagnoses of bipolar disorder I, II, or NOS. Interaction with research staff will occur through phone interviews and email correspondence, as participants will be recruited from any geographic location, providing inclusion criteria are met of a bipolar diagnosis, age 21-65, computer access, and local health care consisting of at least 2 provider visits in the past year and local emergency care. Exclusions are limited to current manic or psychotic symptoms. Utilization of the online MoodSwings 2.0 program is voluntary, and the program captures time spent in each content area over 12 months as an outcome of interest. Outcomes are assessed at quarterly intervals via phone interview with raters blind to group assignment as well as online self report. The primary outcome is the change in depressive symptoms over 12 months, assessing if there is additive benefit to the three components (education, discussion board, and interactive psychosocial tools) on improvement. Exploratory aims include symptoms of elevated mood, health services utilization, evidence of relapse (time to intervention), function, quality of life and medication adherence.