Efficacy of a web-based intervention for improving psychosocial well-being in patients with implantable cardioverter-defibrillators: the randomized controlled ICD-FORUM trial

Stefan M Schulz; Oliver Ritter; Richard Zniva; Peter Nordbeck; Christian Wacker; Mary Jack; Guido Groschup; Thomas Deneke; Frank Puppe; Georg Ertl; Christiane Angermann; Stefan Störk; Paul Pauli

doi:10.1093/eurheartj/ehz134

Efficacy of a web-based intervention for improving psychosocial well-being in patients with implantable cardioverter-defibrillators: the randomized controlled ICD-FORUM trial

Eur Heart J. 2020 Mar 14;41(11):1203-1211. doi: 10.1093/eurheartj/ehz134.

Authors

Stefan M Schulz^{1

2

3}, Oliver Ritter^{1

4}, Richard Zniva¹, Peter Nordbeck^{1

5}, Christian Wacker⁶, Mary Jack⁷, Guido Groschup⁸, Thomas Deneke⁹, Frank Puppe^{1

10}, Georg Ertl¹, Christiane Angermann¹, Stefan Störk^{1

5}, Paul Pauli^{1

2}

Affiliations

¹ Comprehensive Heart Failure Center, University and University Hospital Würzburg, Am Schwarzenberg 15, BY, 97078 Würzburg, Germany.
² Department of Psychology (Biological Psychology, Clinical Psychology, and Psychotherapy), University of Würzburg, Marcusstraße 9-11, BY, 97070 Würzburg, Germany.
³ Clinical Psychology, Psychotherapy, and Experimental Psychopathology, Johannes Gutenberg University Mainz, Wallstraße 3, RP, 55122 Mainz, Germany.
⁴ Department of Cardiologoephrology and Pulmology, Brandenburg Medical School, University Hospital Brandenburg, Hochstraße 29, BB, 14770 Brandenburg an der Havel, Germany.
⁵ Division of Cardiology, Department of Medicine I, University Hospital Würzburg, Oberdürrbacher Straße 6, BY, 97080 Würzburg, Germany.
⁶ Division of Cardiology, Department of Medicine, ANregiomed-Hospital Rothenburg ob der Tauber, Ansbacher Straße 131, BY, 91541 Rothenburg ob der Tauber, Germany.
⁷ Hospital Bad Wörishofen, Tannenbaum 2, BY, 86825 Bad Wörishofen, Germany.
⁸ Division of Rhythmology, Department of Medicine I, City Hospital Aschaffenburg, Am Hasenkopf 1, BY, 63739 Aschaffenburg, Germany.
⁹ Department of Cardiology, Cardiovascular Centre GmbH, Schlossplatz 1, BY, 97616 Bad Neustadt a. d. Saale, Germany.
¹⁰ Chair of Computer Science VI, University of Würzburg, Am Hubland, BY, 97074 Würzburg, Germany.

Abstract

Aims: Anxiety, depression, and reduced quality of life (QoL) are common in patients with implantable cardioverter-defibrillators (ICDs). Treatment options are limited and insufficiently defined. We evaluated the efficacy of a web-based intervention (WBI) vs. usual care (UC) for improving psychosocial well-being in ICD patients with elevated psychosocial distress.

Methods and results: This multicentre, randomized controlled trial (RCT) enrolled 118 ICD patients with increased anxiety or depression [≥6 points on either subscale of the Hospital Anxiety and Depression Scale (HADS)] or reduced QoL [≤16 points on the Satisfaction with Life Scale (SWLS)] from seven German sites (mean age 58.8 ± 11.3 years, 22% women). The primary outcome was a composite assessing change in heart-focused fear, depression, and mental QoL 6 weeks after randomization to WBI or UC, stratified for age, gender, and indication for ICD placement. Web-based intervention consisted of 6 weeks' access to a structured interactive web-based programme (group format) including self-help interventions based on cognitive behaviour therapy, a virtual self-help group, and on-demand support from a trained psychologist. Linear mixed-effects models analyses showed that the primary outcome was similar between groups (ηp2 = 0.001). Web-based intervention was superior to UC in change from pre-intervention to 6 weeks (overprotective support; P = 0.004, ηp2 = 0.036), pre-intervention to 1 year (depression, P = 0.004, ηp2 = 0.032; self-management, P = 0.03, ηp2 = 0.015; overprotective support; P = 0.02, ηp2 = 0.031), and 6 weeks to 1 year (depression, P = 0.02, ηp2 = 0.026; anxiety, P = 0.03, ηp2 = 0.022; mobilization of social support, P = 0.047, ηp2 = 0.018).

Conclusion: Although the primary outcome was neutral, this is the first RCT showing that WBI can improve psychosocial well-being in ICD patients.

Keywords: Anxiety; Depression; Efficacy; Implantable cardioverter-defibrillator; Randomized controlled trial; Web-based intervention.

Publication types

Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

MeSH terms

Aged
Anxiety / prevention & control
Cognitive Behavioral Therapy*
Defibrillators, Implantable*
Depression / therapy
Female
Humans
Internet-Based Intervention*
Male
Middle Aged
Quality of Life