Skruibis Paulius, Eimontas Jonas, Dovydaitiene Migle, Mazulyte Egle, Zelviene Paulina, Kazlauskas Evaldas
Department of Clinical and Organizational Psychology, Vilnius University, Universiteto str. 9/1, Vilnius, 01513, Lithuania.
Department of General Psychology, Vilnius University, Universiteto str. 9/1, Vilnius, 01513, Lithuania.
BMC Psychiatry. 2016 Jul 26;16:264. doi: 10.1186/s12888-016-0980-9.
Adjustment disorder is one of the most common mental health diagnoses. Still it receives relatively little attention from researchers trying to establish best interventions to treat it. With high prevalence of stressful life events, which might be leading to adjustment disorder, and limited resources of mental health service providers, online interventions could be a very practical way of helping people who have these disorders or are in the risk to develop them. The proposed study protocol is aimed to describe a randomized controlled trial of an internet-based modular intervention for adjustment disorder as it is defined in a proposal for the ICD-11.
METHODS/DESIGN: This study is a two-armed Randomized Controlled Trial (RCT) to examine the effectiveness of a web-based intervention BADI (Brief Adjustment Disorder Intervention) for adjustment disorder symptoms. BADI has four modules: Relaxation, Time management, Mindfulness and Strengthening relationships. It is based on stress and coping research and integrates evidence-based treatment approaches such as Cognitive Behavioural therapy (CBT), mindfulness and body-mind practices, as well as exercises for enhancing social support. Primary outcome of the study are symptoms of adjustment disorder and well-being. Engagement into the program and motivation for change is a secondary outcome. All participants after completing the baseline assessment are randomly assigned to one of the two groups: either to the one in which participant will instantly gain access to the BADI intervention or a group in which participants will be given access to the BADI program after waiting one month. Participants of BADI can choose exercises of the program flexibly. There is no particular order in which the exercises should be completed.
Study will provide new insights of modular internet-based interventions efficacy for adjustment disorders. The study will also provide information about the role of motivation and expectancies on engagement in modular internet-based interventions. In case this RCT supports effectiveness of fully automated version of BADI, it could be used very broadly. It could become a cost-effective and accessible intervention for adjustment disorder.
The study was retrospectively registered with the Australian and New Zealand Clinical Trials Registry with the registration number ACTRN12616000883415 . Registered 5 July, 2016.
适应障碍是最常见的心理健康诊断之一。然而，试图确定最佳治疗干预措施的研究人员对其关注相对较少。由于可能导致适应障碍的应激性生活事件普遍存在，且心理健康服务提供者资源有限，在线干预可能是帮助患有这些障碍或有发展这些障碍风险的人的一种非常实用的方式。拟议的研究方案旨在描述一项针对国际疾病分类第11版提案中所定义的适应障碍的基于互联网的模块化干预随机对照试验。
方法/设计：本研究是一项双臂随机对照试验（RCT），以检验基于网络的干预措施BADI（简短适应障碍干预）对适应障碍症状的有效性。BADI有四个模块：放松、时间管理、正念和加强人际关系。它基于压力与应对研究，并整合了基于证据的治疗方法，如认知行为疗法（CBT）、正念和身心练习，以及增强社会支持的练习。该研究的主要结果是适应障碍症状和幸福感。参与该项目和改变的动机是次要结果。所有完成基线评估的参与者被随机分配到两组中的一组：一组参与者将立即获得BADI干预，另一组参与者在等待一个月后将获得BADI项目。BADI的参与者可以灵活选择该项目的练习。练习的完成没有特定顺序。
该研究将为基于互联网的模块化干预对适应障碍的疗效提供新的见解。该研究还将提供有关动机和期望在参与基于互联网的模块化干预中的作用的信息。如果该随机对照试验支持BADI全自动版本的有效性，它可能会得到广泛应用。它可能成为一种经济高效且易于获得的适应障碍干预措施。
该研究已在澳大利亚和新西兰临床试验注册中心进行回顾性注册，注册号为ACTRN12616000883415。于2016年7月5日注册。
