Tailored implementation of internet-based cognitive behavioural therapy in the multinational context of the ImpleMentAll project: a study protocol for a stepped wedge cluster randomized trial.

Tailored implementation of internet-based cognitive behavioural therapy in the multinational context of the ImpleMentAll project: a study protocol for a stepped wedge cluster randomized trial.
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DOI:
10.1186/s13063-020-04686-4
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发表时间:
2020-10-28
期刊:
影响因子:
2.5
通讯作者:
ImpleMentAll consortium
ImpleMentAll consortium
中科院分区:
医学4区
文献类型:
--
作者:
Bührmann L;Schuurmans J;Ruwaard J;Fleuren M;Etzelmüller A;Piera-Jiménez J;Finch T;Rapley T;Potthoff S;Aouizerate B;Batterham PJ;Calear A;Christensen H;Pedersen CD;Ebert DD;Van der Eycken E;Fanaj N;van Genugten C;Hanssen D;Hegerl U;Hug J;Kleiboer A;Mathiasen K;May C;Mustafa S;Oehler C;Cerga-Pashoja A;Pope C;Qirjako G;Rosmalen J;Sacco Y;Samalin L;Skjøth MM;Tarp K;Titzler I;Zanalda E;Zbukvic I;Smit JH;Riper H;Vis C;ImpleMentAll consortium

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基于互联网的认知行为疗法(iCBT)在治疗常见精神障碍方面被发现是有效的。然而,在日常护理中使用这些干预措施是有限的。这项国际研究是由欧盟“地平线2020”项目资助的。它涉及研究和改进在常规精神保健中为常见精神障碍提供循证iCBT服务的方法。将向精神卫生保健组织介绍一个数字化可获取的实施工具包(itfits -工具包),目的是促进在地方范围内持续实施iCBT服务。本研究通过将itfits工具包与常规实施活动进行比较来调查其有效性。采用阶梯楔形随机对照试验(SWT)设计。在30个月的试用期内,itfits工具包将依次在欧洲和澳大利亚9个国家的12个常规精神卫生保健组织的初级和专科保健中引入。应用重复测量来评估结果变量随时间的变化。将根据iCBT服务使用的正常化程度来评估ict工具包的有效性。将测量若干探索性结果,包括iCBT服务的采用情况,以提供对主要结果的解释。数据将通过集中的数据收集系统收集,并使用广义线性混合模型进行分析。本研究将对常规实施活动和itfits工具包的使用进行定性过程评价。ImpleMentAll研究是一项大型国际研究项目,旨在研究量身定制实施的有效性。使用允许随时间变化的SWT设计,本研究将调查定制实施对iCBT服务使用规范化及其吸收的影响。它将提供对裁剪实施策略的过程和方法的更好理解。如果发现该工具包有效,将向精神卫生保健服务提供者提供,以帮助他们克服具体情况下的实施挑战。ClinicalTrials.gov NCT03652883。追溯注册于2018年8月29日
Internet-based Cognitive Behavioural Therapy (iCBT) is found effective in treating common mental disorders. However, the use of these interventions in routine care is limited. The international ImpleMentAll study is funded by the European Union’s Horizon 2020 programme. It is concerned with studying and improving methods for implementing evidence-based iCBT services for common mental disorders in routine mental health care. A digitally accessible implementation toolkit (ItFits-toolkit) will be introduced to mental health care organizations with the aim to facilitate the ongoing implementation of iCBT services within local contexts. This study investigates the effectiveness of the ItFits-toolkit by comparing it to implementation-as-usual activities. A stepped wedge cluster randomized controlled trial (SWT) design will be applied. Over a trial period of 30 months, the ItFits-toolkit will be introduced sequentially in twelve routine mental health care organizations in primary and specialist care across nine countries in Europe and Australia. Repeated measures are applied to assess change over time in the outcome variables. The effectiveness of the ItFits-toolkit will be assessed in terms of the degree of normalization of the use of the iCBT services. Several exploratory outcomes including uptake of the iCBT services will be measured to feed the interpretation of the primary outcome. Data will be collected via a centralized data collection system and analysed using generalized linear mixed modelling. A qualitative process evaluation of routine implementation activities and the use of the ItFits-toolkit will be conducted within this study. The ImpleMentAll study is a large-scale international research project designed to study the effectiveness of tailored implementation. Using a SWT design that allows to examine change over time, this study will investigate the effect of tailored implementation on the normalization of the use of iCBT services and their uptake. It will provide a better understanding of the process and methods of tailoring implementation strategies. If found effective, the ItFits-toolkit will be made accessible for mental health care service providers, to help them overcome their context-specific implementation challenges. ClinicalTrials.gov NCT03652883. Retrospectively registered on 29 August 2018
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