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The coMforT study of a trauma-informed mindfulness intervention for women who have experienced domestic violence and abuse: a protocol for an intervention refinement and individually randomized parallel feasibility trial
Pilot and Feasibility Studies ( IF 1.5 ) Pub Date : 2020-02-28 , DOI: 10.1186/s40814-019-0527-1
Katherine Pitt 1 , Gene S Feder 1, 2 , Alison Gregory 1 , Claire Hawcroft 1 , David Kessler 1, 2 , Alice Malpass 1 , Sarah Millband 1 , Richard Morris 1 , Stan Zammit 1, 2, 3 , Natalia V Lewis 1, 2
Affiliation  

Domestic violence and abuse (DVA) is common and destructive to health. Post-traumatic stress disorder (PTSD) is a major mental health consequence of DVA. People who have experienced DVA have specific needs, arising from the repeated and complex nature of the trauma. The National Institute for Health and Care Excellence recommends more research on the effectiveness of psychological interventions for people who have experienced DVA. There is growing evidence that mindfulness-based interventions may help trauma symptoms. Intervention refinement and randomized controlled feasibility trial. A prototype trauma-informed mindfulness-based cognitive therapy (TI-MBCT) intervention will be co-produced following qualitative interviews and consensus exercise with stakeholders. Participants in the feasibility trial will be recruited from DVA agencies in two geographical regions and randomized to receive either TI-MBCT or usual care (self-referral to the Improving Access to Psychological Therapies (IAPT) service). TI-MBCT will be delivered as a group-based eight-week program. It will not be possible to blind the participants or the assessors to the study allocation. The following factors will inform the feasibility of progressing to a fully powered trial: recruitment, retention, intervention fidelity, and the acceptability of the intervention and trial design to participants. We will also test the feasibility of measuring the following participant outcomes before and 6 months post-randomization: PTSD, dissociative symptoms, depression, anxiety, DVA re-victimization, self-compassion, and mother-reported child health. Process evaluation and economic analysis will be embedded within the feasibility trial. This study will lead to the development of a TI-MBCT intervention for DVA survivors with PTSD and inform the feasibility and design of a fully powered randomized controlled trial (RCT). The full trial will aim to determine the effectiveness and cost-effectiveness of a TI-MBCT intervention in improving the clinically important symptoms of PTSD in DVA survivors. ISRCTN, ISRCTN64458065, Registered 11 January 2019.

中文翻译:

对经历过家庭暴力和虐待的女性进行创伤知情正念干预的舒适研究:干预改进方案和单独随机平行可行性试验

家庭暴力和虐待 (DVA) 很常见,而且对健康有害。创伤后应激障碍 (PTSD) 是 DVA 的主要心理健康后果。经历过 DVA 的人有特定的需求,这是由于创伤的重复性和复杂性引起的。美国国家健康与护理卓越研究所建议对经历过 DVA 的人进行心理干预的有效性进行更多研究。越来越多的证据表明,基于正念的干预措施可能有助于缓解创伤症状。干预细化和随机对照可行性试验。在与利益相关者进行定性访谈和共识练习之后,将共同制作一个原型创伤知情正念认知疗法 (TI-MBCT) 干预。可行性试验的参与者将从两个地理区域的 DVA 机构招募,并随机接受 TI-MBCT 或常规护理(自我推荐到改善心理治疗 (IAPT) 服务)。TI-MBCT 将作为一个为期八周的小组课程提供。不可能使参与者或评估者对研究分配视而不见。以下因素将告知推进到完全动力试验的可行性:招募、保留、干预保真度以及干预和试验设计对参与者的可接受性。我们还将测试在随机化之前和之后 6 个月测量以下参与者结果的可行性:PTSD、分离症状、抑郁、焦虑、DVA 再次受害、自我同情和母亲报告的儿童健康。工艺评估和经济分析将嵌入可行性试验中。该研究将为患有 PTSD 的 DVA 幸存者开发 TI-MBCT 干预措施,并为全动力随机对照试验 (RCT) 的可行性和设计提供信息。完整的试验旨在确定 TI-MBCT 干预在改善 DVA 幸存者 PTSD 临床重要症状方面的有效性和成本效益。ISRCTN,ISRCTN64458065,2019 年 1 月 11 日注册。完整的试验旨在确定 TI-MBCT 干预在改善 DVA 幸存者 PTSD 临床重要症状方面的有效性和成本效益。ISRCTN,ISRCTN64458065,2019 年 1 月 11 日注册。完整的试验旨在确定 TI-MBCT 干预在改善 DVA 幸存者 PTSD 临床重要症状方面的有效性和成本效益。ISRCTN,ISRCTN64458065,2019 年 1 月 11 日注册。
更新日期:2020-04-22
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