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The Screen-ICD trial. Screening for anxiety and cognitive therapy intervention for patients with implanted cardioverter defibrillator (ICD): a randomised controlled trial protocol
  1. Selina Kikkenborg Berg1,2,3,
  2. Margrethe Herning4,
  3. Jesper Hastrup Svendsen1,5,
  4. Anne Vinggaard Christensen1,
  5. Lau Caspar Thygesen2
  1. 1The Heart Centre, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark
  2. 2National Institute of Public Health, University of Southern Denmark, Copenhagen, Denmark
  3. 3Department of Public Health, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark
  4. 4Department of Cardiology, Herlev and Gentofte University Hospital, Hellerup, Denmark
  5. 5Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark
  1. Correspondence to Dr Selina Kikkenborg Berg; selina{at}rh.dk

Abstract

Introduction Previous research shows that patients with an implanted cardioverter defibrillator (ICD) have a fourfold increased mortality risk when suffering from anxiety compared with ICD patients without anxiety. This research supports the screening of ICD patients for anxiety with the purpose of starting relevant intervention.

Methods and analysis Screen-ICD consists of 3 parts: (1) screening of all hospitalised and outpatient patients at two university hospitals using the Hospital Anxiety and Depression Scale (HADS), scores ≥8 are invited to participate. (2) Assessment of type of anxiety by Structured Clinical Interview for DSM Disorders (SCID). (3) Investigator-initiated randomised clinical superiority trial with blinded outcome assessment, with 1:1 randomisation to cognitive–behavioural therapy (CBT) performed by a cardiac nurse with CBT training, plus usual care or usual care alone. The primary outcome is HADS-A measured at 16 weeks. Secondary outcomes include Becks Anxiety Inventory, HeartQoL, Hamilton Anxiety Scale, heart rate variability, ICD shock, time to first shock and antitachycardia pacing. A total of 88 participants will be included. The primary analyses are based on the intention-to-treat principle and we use a mixed model with repeated measurements for continuous outcomes. For binary outcomes (HADS-A score <8), we use a generalised mixed model with repeated measurements.

Ethics and dissemination 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 (RH-2015-282) and the regional ethics committee (H-16018868). Positive, neutral and negative results of the trial will be published.

Trial registration number NCT02713360.

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

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Footnotes

  • Contributors SKB conceived the idea of the study. SKB, MH, JHS and AVC initiated the study design and implementation. LCT and SKB developed the plan for the statistical analyses. All contributed to the refinement of the study protocol.

  • Funding Screen-ICD will be conducted at the Heart Centre, Rigshospitalet and at the Department of Cardiology at Herlev and Gentofte Hospital. The trial is funded by the above sites and by Trygfonden ID 117364.

  • Competing interests None declared.

  • Ethics approval The regional ethics committee (H-16018868).

  • Provenance and peer review Not commissioned; externally peer reviewed.