Braadt Lino, Fischer Simone, Naumann Markus, Zickler Philipp, Schneider-Axmann Thomas, Mühlich Laura, Körber Katharina, Lassner Alexander, Strube Wolfgang, Röh Astrid, Hasan Alkomiet, Ertl Michael
Neurology, Faculty of Medicine, University of Augsburg, Stenglinstrasse 2, 86156, Augsburg, Germany.
Epidemiology, Faculty of Medicine, University of Augsburg, Stenglinstrasse 2, 86156, Augsburg, Germany.
Neurol Res Pract. 2024 Dec 11;6(1):61. doi: 10.1186/s42466-024-00347-y.
Besides functional outcomes, mental health and health-related quality of life (HRQoL) are significant measures in chronic diseases, such as stroke. Post-stroke depression (PSD) is an important complication affecting up to one in three stroke survivors. So far, specific programs to screen, detect and treat these patients are lacking but might be a crucial component in stroke aftercare.
Between March 2024 and Febuary 2025 all consecutive adult patients with stroke, admitted to the University Hospital of Augsburg, are screened for signs of depression (PHQ-9 (Patient Health Questionnaire-9) score of ≥ 10). Eight weeks later, those patients with persisting signs of depression will be randomized to receive either a behavioural activation intervention or a mindfulness-based intervention via telephone. Depressive symptoms will be assessed at baseline (V1), after 84, 180 (V2-V3) and after 365 days (V4) using the PHQ-9 score. Secondary outcomes include the functional outcome, quality of life (EuroQol-5 Dimensions; EQ-5D), overall functioning, and incidence of major cardiovascular events including recurrent transient ischemic attack, stroke, and mortality.
Our aim is to provide proof-of-concept evidence for the efficacy of telepsychological need-adapted interventions for patients with post-stroke depression. Regular screening for PSD with implementation of a feasible treatment option could reduce the long-term prevalence of PSD and improve quality of life.
This trial was registered at German Clinical Trials Register (DRKS) on 07.03.2024, ID: DRKS00033792. German Clinical Trials Register (drks.de).
除功能结局外,心理健康和健康相关生活质量(HRQoL)是慢性病(如中风)的重要衡量指标。中风后抑郁(PSD)是一种重要的并发症,影响多达三分之一的中风幸存者。到目前为止,缺乏针对这些患者进行筛查、检测和治疗的具体方案,但这可能是中风后护理的关键组成部分。
在2024年3月至2025年2月期间,对奥格斯堡大学医院收治的所有连续成年中风患者进行抑郁症状筛查(患者健康问卷-9(PHQ-9)评分≥10)。八周后,那些仍有抑郁症状的患者将被随机分组,通过电话接受行为激活干预或基于正念的干预。使用PHQ-9评分在基线(V1)、84天、180天(V2-V3)和365天后(V4)评估抑郁症状。次要结局包括功能结局、生活质量(欧洲五维健康量表;EQ-5D)、整体功能以及包括复发性短暂性脑缺血发作、中风和死亡率在内的主要心血管事件的发生率。
我们的目标是为中风后抑郁患者的远程心理需求适应性干预的疗效提供概念验证证据。通过实施可行的治疗方案对PSD进行定期筛查,可以降低PSD的长期患病率并改善生活质量。
本试验于2024年3月7日在德国临床试验注册中心(DRKS)注册,注册号:DRKS00033792。德国临床试验注册中心(drks.de)。