Schoultz Mariyana, Atherton Iain, Watson Angus
Centre for Health Science, School of Health Sciences, University of Stirling, Inverness, Scotland, UK.
Nursing, Midwifery & Social Care, Napier University, Edinburgh, Scotland, UK.
Trials. 2015 Aug 25;16:379. doi: 10.1186/s13063-015-0909-5.
BACKGROUND: Inflammatory bowel disease (IBD) is a chronic gastrointestinal condition with a relapsing disease course. Managing the relapsing nature of the disease causes daily stress for IBD patients; thus, IBD patients report higher rates of depression and anxiety than the general population. Mindfulness-based Cognitive Therapy (MBCT) is an evidence-based psychological program designed to help manage depressive and stress symptoms. There has been no randomized controlled trial (RCT) testing the use of MBCT in IBD patients. The purpose of this pilot study is to test the trial methodology and assess the feasibility of conducting a large RCT testing the effectiveness of MBCT in IBD. METHODS: The IBD patients, who were recruited from gastroenterology outpatient clinics at two Scottish NHS Boards, were randomly allocated to an MBCT intervention group (n = 22) or a wait-list control group (n = 22). The MBCT intervention consisted of 16 hours of structured group training over 8 consecutive weeks plus guided home practice and follow-up sessions. The wait-list group received a leaflet entitled 'Staying well with IBD'. All participants completed a baseline, post-intervention and 6-month follow up assessment. The key objectives were to assess patient eligibility and recruitment/dropout rate, to calculate initial estimates of parameters to the proposed outcome measures (depression, anxiety, disease activity, dispositional mindfulness and quality of life) and to estimate sample size for a future large RCT. RESULTS: In total, 350 patients were assessed for eligibility. Of these, 44 eligible patients consented to participate. The recruitment rate was 15%, with main reasons for ineligibility indicated as follows: non-response to invitation, active disease symptoms, planned surgery or incompatibility with group schedule. There was a higher than expected dropout rate of 44%. Initial estimates of parameters to the proposed outcomes at post-intervention and follow-up showed a significant improvement of scores in the MBCT group when compared to the control for depression, trait anxiety and dispositional mindfulness. The sample-size calculation was guided by estimates of clinically important effects in depression scores. CONCLUSIONS: This pilot study suggests that a multicentre randomized clinical trial testing the effectiveness of MBCT for IBD patients is feasible with some changes to the protocol. Improvement in depression, trait anxiety and dispositional mindfulness scores are promising when coupled with patients reporting a perceived improvement of their quality of life. TRIAL REGISTRATION: ISRCTN27934462. 2 August 2013.
背景:炎症性肠病(IBD)是一种慢性胃肠道疾病,病程呈复发态势。应对该疾病的复发特性给IBD患者带来了日常压力;因此,IBD患者报告的抑郁和焦虑发生率高于普通人群。基于正念的认知疗法(MBCT)是一项循证心理项目,旨在帮助管理抑郁和压力症状。尚无随机对照试验(RCT)测试MBCT在IBD患者中的应用。这项初步研究的目的是测试试验方法,并评估开展一项大型RCT以测试MBCT对IBD有效性的可行性。 方法:从苏格兰两个国民保健服务委员会的胃肠病门诊招募IBD患者,将其随机分配至MBCT干预组(n = 22)或等待名单对照组(n = 22)。MBCT干预包括连续8周共16小时的结构化小组培训,外加指导下的家庭练习和随访。等待名单组收到一份题为“与IBD和谐共处”的传单。所有参与者均完成了基线、干预后及6个月随访评估。主要目标是评估患者的合格性及招募/退出率,计算拟议结局指标(抑郁、焦虑、疾病活动度、特质正念和生活质量)参数的初始估计值,并估计未来大型RCT的样本量。 结果:总共评估了350名患者的合格性。其中,44名合格患者同意参与。招募率为15%,不符合资格的主要原因如下:未回复邀请、有活动性疾病症状、计划进行手术或与小组日程安排不兼容。退出率高于预期,为44%。干预后及随访时拟议结局参数的初始估计值显示,与对照组相比,MBCT组在抑郁、特质焦虑和特质正念方面的得分有显著改善。样本量计算以抑郁评分中具有临床重要意义的效应估计值为指导。 结论:这项初步研究表明,对方案进行一些修改后,开展一项测试MBCT对IBD患者有效性的多中心随机临床试验是可行的。抑郁、特质焦虑和特质正念得分的改善很有前景,同时患者报告其生活质量有明显改善。 试验注册:ISRCTN27934462。2013年8月2日。
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