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临床试验/NCT06174051
NCT06174051尚未招募不适用

The Effectiveness of Flashforward EMDR Treatment for Patients With an ICD

Erasmus Medical Center0 个研究点目标入组 33 人开始时间: 2024年2月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
33
主要终点
Cardiac Anxiety Questionnaire (CAQ)

研究概览

简要总结

The goal of this randomized controlled trial is to test whether flashforward (FF) EMDR alone is effective in reducing anxiety symptoms in patients with an implantable cardioverter defibrillator (ICD). Participants will fill out several questionnaires to asses their level of anxiety, depression symptoms and quality of life before, during and after treatment.

详细描述

Patients with an implantable cardioverter defibrillator (ICD) are at risk of ventricular arrhythmias (VA). The ICD is a device that can treat VA by antitachycardia pacing or ICD shocks. Since ICD shocks are painful and unpredictable, patients with an ICD can suffer from anxiety symptoms. Eye movement desensitization and reprocessing treatment (EMDR) is an effective treatment to enhance the process of traumatic events. In addition, this treatment has also shown to be able to reduce anxiety symptoms. EMDR treatment according to standard protocol starts with flashback (FB) procedure and may be followed by the flashforward (FF) procedure. The FB procedure focusses on events that happened in the past, while the FF procedure aims to reduce fear evoked by images of imagined future adverse events. So far, it is not clear whether the FB procedure is always necessary for the EMDR treatment to be effective. Moving straight towards application of the FF procedure (without first applying the FB procedure), may save treatment time and costs. Therefore, the main objective in this study is to test whether flashforward (FF) EMDR alone is effective in reducing anxiety symptoms in ICD patients. This will be tested with a pilot randomized controlled trial with a three-arm repeated measures design. Subjects will either receive FF EMDR, FB EMDR or no EMDR during the study. To measure their heart focussed anxiety, subjects will fill out the Cardiac Anxiety Questionnaire (CAQ) before, during and after treatment or waiting period.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

盲法说明

The study will have an open label, since the care provider (the psychologist) needs to know which procedure to follow and the participants will understand in which group they are once the therapy start.

入排标准

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

入选标准

  • subjects have an ICD;
  • subjects have clinical anxiety symptoms related to their ICD.

排除标准

  • insufficient knowledge on Dutch or English language;
  • severe psychiatric disorders that warrant (other) psychiatric first, such as suicidality or psychotic disorders

结局指标

主要结局

Cardiac Anxiety Questionnaire (CAQ)

时间窗: Baseline (Before treatment T0), after the first treatment session T1(for wait list after 2 weeks), and after the second treatment session T2 (for wait list after 4 weeks)

Self-report questionnaire to asses heart focussed anxiety

次要结局

  • PTSD Check-List (PCL-5)(Baseline (Before treatment T0) and after the second treatment session T2 (for wait list after 4 weeks))
  • Patient Health Questionnaire (PHQ-9)(Baseline (Before treatment T0) and after the second treatment session T2 (for wait list after 4 weeks))
  • General Anxiety Questionnaire (GAD-7)(Baseline (Before treatment T0) and after the second treatment session T2 (for wait list after 4 weeks))
  • EuroQol (EQ5D-5L)(Baseline (Before treatment T0) and after the second treatment session T2 (for wait list after 4 weeks))

研究者

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

Leonieke Kranenburg

Associate professor

Erasmus Medical Center

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