Department of Women's and Children's Health, Uppsala University, Uppsala, Sweden.
Department of Psychology and Social Work, Mid Sweden University, Östersund, Sweden.
Trials. 2022 Jul 26;23(1):597. doi: 10.1186/s13063-022-06530-3.
In the aftermath of a myocardial infarction with non-obstructive coronary arteries (MINOCA) or Takotsubo syndrome (TS), patients commonly express high levels of stress and anxiety. Current treatment alternatives rarely address these issues.
The study is a randomised controlled trial, where 90 patients with a discharge diagnosis of MINOCA or TS who also report symptoms of stress or anxiety will be randomised 2-6 weeks after their cardiac event. The treatment consists of 10 weeks of Internet-based cognitive behaviour therapy (CBT) and starts immediately after randomisation for the treatment group. The control group receives usual care. Main outcomes are symptoms of anxiety measured with the Hospital Anxiety and Depression scale, anxiety subscale, and perceived stress measured with the Perceived Stress Scale, 14-item version, 10 weeks after randomisation. Secondary measures include cardiac specific anxiety, symptoms of post-traumatic stress, quality of life, cortisol measured in hair and physiological stress responses (heart rate variability, blood pressure and saliva cortisol) during a stress procedure. Ten weeks after randomisation, the control group will also receive treatment. Long-term follow-up in the self-report measures mentioned above will be conducted 20 and 50 weeks after randomisation where the total group's development over time is followed, and the groups receiving intervention early versus late compared.
At present, there are no randomised studies evaluating psychological treatment for patients with MINOCA or TS. There is an urgent need for treatment alternatives aiming at relieving stress and anxiety considering the high mental stress and anxiety levels observed in MINOCA and TS, leading to decreased quality of life. CBT aiming at reducing mental stress has been shown to be effective regarding prognosis in patients with coronary artery disease. The current protocol describes a randomised open-label controlled trial evaluating an Internet-based CBT program for reduction of stress and anxiety in patients with increased mental stress and/or anxiety with a discharge diagnosis of either MINOCA or TS.
ClinicalTrials.gov NCT04178434 . Registered on 26 November 2019.
在非阻塞性冠状动脉心肌梗死（MINOCA）或心尖球形综合征（Takotsubo 综合征，TS）后，患者通常表现出高度的压力和焦虑。目前的治疗选择很少能解决这些问题。
这是一项随机对照试验研究，90 名经诊断为 MINOCA 或 TS 且报告有压力或焦虑症状的患者，在心脏事件发生后 2-6 周内随机分组。治疗包括 10 周的基于互联网的认知行为疗法（CBT），并在随机分组后立即开始对治疗组进行治疗。对照组接受常规护理。主要结局是在随机分组后 10 周时，用医院焦虑抑郁量表、焦虑分量表和 14 项知觉压力量表测量焦虑症状，10 周后进行二次测量，包括心脏特定焦虑、创伤后应激症状、生活质量、头发中的皮质醇和应激过程中的心率变异性、血压和唾液皮质醇。随机分组后 10 周，对照组也将接受治疗。在随机分组后 20 和 50 周时，将对上述自我报告措施进行长期随访，以跟踪总组随时间的发展情况，并比较早期和晚期接受干预的组。
目前，没有评估 MINOCA 或 TS 患者心理治疗的随机研究。MINOCA 和 TS 患者观察到精神压力和焦虑水平较高，导致生活质量下降，因此迫切需要缓解压力和焦虑的治疗选择。针对冠状动脉疾病患者，减少精神压力的 CBT 已显示出对预后的有效性。本方案描述了一项随机开放标签对照试验，评估了一种基于互联网的 CBT 方案，用于减少精神压力和/或焦虑增加、诊断为 MINOCA 或 TS 的患者的压力和焦虑。
ClinicalTrials.gov NCT04178434。注册于 2019 年 11 月 26 日。
