Lessons from a pilot and feasibility randomised trial in depression (Blood pressure Rapid Intensive Lowering And Normal Treatment for Mood and cognition in persistent depression (BRILiANT mood study)).
Lessons from a pilot and feasibility randomised trial in depression (Blood pressure Rapid Intensive Lowering And Normal Treatment for Mood and cognition in persistent depression (BRILiANT mood study)).
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抑郁症的试验和可行性随机试验的经验教训（血压快速降低和正常治疗持续性抑郁症的情绪和认知（Briliant Mood研究））。
DOI：
10.1186/s40814-015-0042-y
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发表时间：
2015
影响因子：
1.7
通讯作者：
Thomas A
中科院分区：
文献类型：
--
作者：
Olsen K;Howel D;Barber R;Ford GA;Gallagher P;McAllister-Williams RH;Nilsson J;O'Brien J;Parker J;Thomas A
持续性抑郁症患者的血压快速强化降低和情绪和认知的正常治疗（BRILiANT情绪研究）被设计为一项试点研究，旨在研究强化降低血压作为重度抑郁症老年人持续性情绪和认知症状治疗的可行性和安全性，并评估招募该人群的可用性。此外，还将研究血压降低与脑血流量和情绪变化之间的关系。本研究是一项单中心初步随机对照试验（RCT），包括两个平行组，分别接受高血压强化治疗或正常治疗，从初级和二级保健和报纸广告中招募，目的是招募66名参与者。在征聘期结束时，为了探讨未能按目标征聘的原因，编制了调查表并分发给参与征聘的人员。招募率低于预期，导致研究扩大到其他领域，并通过广告开放自我推荐。然而，由于英国血压治疗质量和结局框架指南的变化，高血压的管理更好，因此很少有合格的患者被确定，研究在招募期结束时关闭，13名参与者同意，但12名筛选失败，导致一名招募的参与者。总的来说，发现BRILiANT情绪研究不可行，结果表明预期的患者人群不再存在。为了克服这种招募困难，在资助后立即开始研究，这样就不会发生相关的护理变化，这可能有助于防止未来研究中出现类似的问题。此外，自我推荐，在这种情况下通过报纸广告，可能是一个有用的工具，以提高答复率。在初级保健招募时，以安全和匿名的方式直接访问初级保健数据库可以实现更有效的筛选。最终，BriLiANT情绪研究被证明是不可行的;这是这项试点研究的一个有用结论。ISRCTN 64524251; UKCRN产品组合编号：13284
The blood pressure rapid intensive lowering and normal treatment for mood and cognition in persistent depression (BRILiANT mood study) was devised as a pilot study to investigate the feasibility and safety of intensive blood pressure lowering as treatment for persistent mood and cognitive symptoms in older adults with major depressive disorder and to assess the availability of this population for recruitment. In addition, the relationship between reduced blood pressure and the change in cerebral blood flow and mood was to be investigated. A single centre pilot randomised controlled trial (RCT), with two parallel groups of intensive or normal treatment for hypertension, recruiting from primary and secondary care and newspaper advert, with an aim of recruiting 66 participants, was observed in this study. At the end of the recruitment period, in order to explore the reasons for failure to recruit to target, surveys were developed and issued to those involved in recruitment. Recruitment rates were lower than expected which led to the study being expanded to further areas and opened to self-referral via advertisement. However, because of better management of hypertension due to changes in the UK Quality and Outcomes Framework guidelines for blood pressure treatment, few eligible patients were identified and the study closed at the end of the recruitment period, with 13 participants consenting, but 12 failing screening resulting in one recruited participant. Overall, the BRILiANT mood study was found not to be feasible, and results suggest that the expected patient population no longer exists. To overcome such recruitment difficulties, a prompt commencement of a study after funding so no relevant care changes occur might help prevent similar problems in future studies. In addition, self-referral, in this case via advertisement in papers, may be a useful tool to increase response rate. When recruiting in primary care, direct access to primary care databases, in a secure and anonymised way, may enable more effective screening. Ultimately, the BRILiANT mood study was shown not to be feasible; this was a useful conclusion from this pilot study. ISRCTN 64524251; UKCRN Portfolio No: 13284