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临床试验/NCT05087238
NCT05087238已完成不适用

Cognitive Behavior Therapy for Patients With Premature Ventricular Contractions - a Pilot Study

Karolinska Institutet1 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2021年1月14日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
19
试验地点
1
主要终点
Premature Ventricular Contractions effect on Quality-of-life (PVCEQT)

研究概览

简要总结

The purpose of the present interdisciplinary research program is to develop and evaluate a disease-specific cognitive behavior therapy (CBT) protocol to increase quality of life (QoL) and reduce symptom burden in patients with Premature Ventricular Contractions (PVC).

详细描述

Patients will be recruited in collaboration with arrythmia specialist units in Stockholm and through advertisement in local newspapers and social media. All patients giving informed consent will be screened thoroughly by the research nurse and a psychologist before included by the study cardiologist. 20-30 patients that meet eligibility criteria will be included and receive 8-10 sessions of cognitive behavior therapy during 8-10 weeks. Due to the current Covid-19 pandemic, treatment will be delivered face-to face through a secure digital platform. The psychologist delivering the treatment will have direct access to the study cardiologist during treatment. Follow-up at 3 and 6 months.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Premature Ventricular Contractions effect on Quality-of-life (PVCEQT)

时间窗: 8 months from baseline

Version of the Atrial Fibrillation effects on Quality-of-life (AFEQT), adjusted to Premature Ventricular Contractions. Measures PVC-specific Quality of life in several domains. 14 questions graded on a 7 points likert scale. The total score ranges between 0 (severe symptoms and disability) and 98 (no symptoms and disability)

次要结局

  • Arrhythmia burden(8 months from baseline)
  • Cardiac anxiety questionnaire (CAQ)(8 months from baseline)
  • 12-Item Short-Form Health Survey (SF-12)(8 months from baseline)
  • Symptom Checklist (SCL)(8 months from baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Frieder Braunschweig

Professor

Karolinska Institutet

研究点 (1)

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