Mansell Warren, Tai Sara, Clark Alexandra, Akgonul Savas, Dunn Graham, Davies Linda, Law Heather, Morriss Richard, Tinning Neil, Morrison Anthony P
The Psychosis Research Unit, GMW Mental Health NHS Foundation Trust, Harrop House, Bury New Road, Prestwich, Manchester M25 3BL, UK.
Trials. 2014 Oct 24;15:405. doi: 10.1186/1745-6215-15-405.
Existing psychological therapies for bipolar disorders have been found to have mixed results, with a consensus that they provide a significant, but modest, effect on clinical outcomes. Typically, these approaches have focused on promoting strategies to prevent future relapse. An alternative treatment approach, termed 'Think Effectively About Mood Swings' (TEAMS) addresses current symptoms, including subclinical hypomania, depression and anxiety, and promotes long-term recovery. Following the publication of a theoretical model, a range of research studies testing the model and a case series have demonstrated positive results. The current study reports the protocol of a feasibility randomized controlled trial to inform a future multi-centre trial.
METHODS/DESIGN: A target number of 84 patients with a diagnosis of bipolar I or II disorder, or bipolar disorder not-otherwise-specified are screened, allocated to a baseline assessment and randomized to either 16 sessions of TEAMS therapy plus treatment-as-usual (TAU) or TAU. Patients complete self-report inventories of depression, anxiety, recovery status and bipolar cognitions targeted by TEAMS. Assessments of diagnosis, bipolar symptoms, medication, access to services and quality of life are conducted by assessors blind to treatment condition at 3, 6, 12 and 18 months post-randomization. The main aim is to evaluate recruitment and retention of participants into both arms of the study, as well as adherence to therapy, to determine feasibility and acceptability. It is predicted that TEAMS plus TAU will reduce self-reported depression in comparison to TAU alone at six months post-randomization. The secondary hypotheses are that TEAMS will reduce the severity of hypomanic symptoms and anxiety, reduce bipolar cognitions, improve social functioning and promote recovery compared to TAU alone at post-treatment and follow-up. The study also incorporates semi-structured interviews about the experiences of previous treatment and the experience of TEAMS therapy that will be subject to qualitative analyses to inform future developments of the approach.
The design will provide preliminary evidence of efficacy, feasibility, acceptability, uptake, attrition and barriers to treatment to design a definitive trial of this novel intervention compared to treatment as usual.
This trial was registered with Current Controlled Trials (ISRCTN83928726) on registered 25 July 2014.
已发现现有的双相情感障碍心理疗法效果不一，人们普遍认为这些疗法对临床结果有显著但有限的影响。通常，这些方法侧重于推广预防未来复发的策略。另一种治疗方法，称为“有效应对情绪波动”（TEAMS），可解决当前症状，包括亚临床轻躁狂、抑郁和焦虑，并促进长期康复。在一个理论模型发表后，一系列检验该模型的研究以及一个病例系列均显示出积极结果。本研究报告了一项可行性随机对照试验的方案，为未来的多中心试验提供依据。
方法/设计：筛选84名诊断为双相I型或II型障碍或未另行指定的双相情感障碍患者，进行基线评估，并随机分为接受16次TEAMS疗法加常规治疗（TAU）或仅接受TAU。患者完成针对TEAMS的抑郁、焦虑、康复状态和双相认知的自我报告量表。在随机分组后3、6、12和18个月，由对治疗情况不知情的评估人员对诊断、双相症状、用药、服务获取情况和生活质量进行评估。主要目的是评估研究两组中参与者的招募和留存情况，以及对治疗的依从性，以确定可行性和可接受性。预计与仅接受TAU相比，在随机分组后6个月，TEAMS加TAU将降低自我报告的抑郁程度。次要假设是，与仅接受TAU相比在治疗后及随访时，TEAMS将降低轻躁狂症状和焦虑的严重程度，减少双相认知，改善社会功能并促进康复。该研究还纳入了关于既往治疗经历和TEAMS疗法体验的半结构化访谈，这些访谈将进行定性分析，以为该方法的未来发展提供参考。
该设计将为与常规治疗相比的这种新型干预措施的疗效、可行性、可接受性、采用率、损耗率和治疗障碍提供初步证据，以设计一项确定性试验。
本试验于2014年7月25日在当前对照试验（ISRCTN83928726）注册。
