Knight Matthew James, Baune Bernhard T
Discipline of Psychiatry, University of Adelaide, Adelaide, SA, Australia.
Front Psychiatry. 2017 Dec 12;8:280. doi: 10.3389/fpsyt.2017.00280. eCollection 2017.
Psychosocial dysfunction is associated with poor longitudinal course of depression and is not sufficiently addressed by existing pharmaceutical or psychological treatments. The aim of the current study is to evaluate the efficacy of a novel intervention designed to improve psychosocial function in depressed individuals. Impaired cognition, emotion processing, and social cognition appear to underlie (i.e., cause) psychosocial dysfunction in depression. The current treatment will target functioning in these domains (i.e., cognition, emotion, social cognition) with repeated training tasks, following the rationale that therapeutic benefits will arise in psychosocial functioning. It is expected that personalizing treatment by participants' baseline functioning will enhance clinical efficacy, by comparison with standard treatment in which baseline functioning is not considered.
The study is a randomized, controlled treatment (RCT), in which the efficacy of a personalized and standard intervention will be compared. Sixteen treatment sessions will be administered over an 8-week period. These treatments are designed to improve cognition, emotion processing and social cognition. Assessments of psychosocial functioning, as well as a number of secondary outcomes, will occur at baseline, 4 weeks (mid-RCT), 8 weeks (end of RCT), and in the observational period at baseline (week 9) and 3 and 6 months post-RCT. Recruitment will commence in July 2017, including subjects diagnosed with major depressive disorder according to DSM-IV-TR criteria.
This research will provide new insight into the roles of cognition, emotion processing, and social cognition in psychosocial dysfunction in depression. In addition, the relative clinical efficacy of personalized versus standard treatment approaches will be assessed.
This study has been approved by the human research ethics committees of the Royal Adelaide Hospital and the University of Adelaide (ethics code: R20170611). The study has been registered with the Australia and New Zealand Clinical Trials Registry Registration number: ACTRN12617000899347, web link: http://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12617000899347p. The results of the current study will be published in academic journals following completion of recruitment in 2019. Data will be owned and retained by the University of Adelaide, with access restricted to the research team responsible for the study.
心理社会功能障碍与抑郁症的不良纵向病程相关，现有药物或心理治疗对此处理不足。本研究的目的是评估一种旨在改善抑郁症患者心理社会功能的新型干预措施的疗效。认知、情绪加工和社会认知受损似乎是抑郁症心理社会功能障碍的潜在原因。当前治疗将通过重复训练任务针对这些领域（即认知、情绪、社会认知）的功能，基于这样的原理，即心理社会功能将产生治疗效益。预计与不考虑基线功能的标准治疗相比，根据参与者的基线功能进行个性化治疗将提高临床疗效。
本研究为随机对照治疗（RCT），将比较个性化干预和标准干预的疗效。在8周内进行16次治疗。这些治疗旨在改善认知、情绪加工和社会认知。心理社会功能评估以及一些次要结果将在基线、4周（RCT中期）、8周（RCT结束时）以及观察期的基线（第9周）和RCT后3个月及6个月时进行。招募将于2017年7月开始，纳入根据《精神疾病诊断与统计手册》第四版修订版（DSM-IV-TR）标准诊断为重度抑郁症的受试者。
本研究将为认知、情绪加工和社会认知在抑郁症心理社会功能障碍中的作用提供新的见解。此外，将评估个性化治疗与标准治疗方法的相对临床疗效。
本研究已获得皇家阿德莱德医院和阿德莱德大学人类研究伦理委员会的批准（伦理代码：R20170611）。该研究已在澳大利亚和新西兰临床试验注册中心注册，注册号：ACTRN12617000899347，网页链接：http://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12617000899347p。本研究结果将在2019年完成招募后发表在学术期刊上。数据归阿德莱德大学所有并保留，仅研究团队中负责该研究的人员可访问。
