The Heart Centre, Copenhagen University Hospital, Rigshospitalet, Copenhagen O, 2100, Denmark
Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen N, 2200, Denmark.
BMJ Open. 2021 Dec 3;11(12):e057085. doi: 10.1136/bmjopen-2021-057085.
Patients with cardiac disease often experience anxiety (prevalence about 20%-25%) and have a doubled mortality risk when suffering from anxiety compared with patients without anxiety. This calls for interventions aiming to reduce anxiety.
The Heart & Mind Trial consists of three parts: (1) screening of all hospitalised and outpatient cardiac patients with arrhythmia, heart failure or ischaemic heart disease at four university hospitals in Denmark using the Hospital Anxiety and Depression Scale-Anxiety subscale (HADS-A); Patients scoring ≥8 is invited to participate; (2) Assessment of the type of anxiety by Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders and (3) Randomised clinical superiority trial with blinded outcome assessment, with 1:1 randomisation to cognitive-behavioural therapy (CBT) performed by a CBT-trained cardiac nurse plus usual care or, usual care alone. The primary outcome is anxiety measured with HADS-A at 5 months. Secondary outcomes include anxiety symptoms measured with Becks Anxiety Inventory and heart rate variability. Exploratory outcomes measured at 12 months include blood cortisol (stress response), blood C reactive protein (stress response), health-related quality of life, readmission, mortality and attributable direct costs. A total of 336 patients will be included. The primary analyses are based on the intention-to-treat principle. For the primary outcome, we will use a linear regression model. For the long-term outcomes, mixed regression models will be used including repeated measurements.
The trial is performed in accordance with the Declaration of Helsinki. All patients must give informed consent prior to participation and the trial is initiated after approval by the Danish Data Protection Agency (P-2020-894) and the National Committee on Health Research Ethics (H-20066739). Positive, neutral and negative results of the trial will be published.
NCT04582734.
患有心脏疾病的患者常伴有焦虑（发生率约为 20%-25%），与无焦虑的患者相比，焦虑患者的死亡率增加了一倍。这就需要进行干预以降低焦虑。
“心脏与思维试验”由三部分组成：（1）在丹麦的四所大学医院，使用医院焦虑和抑郁量表焦虑分量表（HADS-A）对心律失常、心力衰竭或缺血性心脏病的所有住院和门诊心脏患者进行筛查；得分≥8 的患者将被邀请参与；（2）通过结构化临床访谈对焦虑类型进行诊断和统计手册精神障碍的诊断与统计手册进行评估；（3）采用盲法结局评估的 1:1 随机对照临床试验，将 1:1 随机分为认知行为疗法（CBT）组，由接受过 CBT 培训的心脏护士加常规护理进行治疗，或单独进行常规护理。主要结局是在 5 个月时用 HADS-A 评估焦虑。次要结局包括贝克焦虑量表（Becks Anxiety Inventory）评估的焦虑症状和心率变异性。12 个月时测量的探索性结局包括血皮质醇（应激反应）、血 C 反应蛋白（应激反应）、健康相关生活质量、再入院、死亡率和归因于直接费用。共纳入 336 例患者。主要分析基于意向治疗原则。对于主要结局，我们将使用线性回归模型。对于长期结局，将使用混合回归模型，包括重复测量。
试验符合赫尔辛基宣言。所有患者在参与前必须给予知情同意，试验在丹麦数据保护局（P-2020-894）和国家卫生研究伦理委员会（H-20066739）批准后启动。试验的阳性、中性和阴性结果将予发表。
NCT04582734。
