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, 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

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.

© The Author(s) 2019. Published by Oxford University Press on behalf of the European Society of Cardiology.

Figures

Figure 1
Figure 1
Weekly content superimposed on the user interface of the web-based intervention (originally in German). Left pane: menu to access weekly topics. Upper middle pane: trained psychologist contact and patient discussion board. Upper right pane: individual settings, including printable individualized emergency plan. Main pane: content as hypertext and interactive elements.
Figure 2
Figure 2
Participant flow through the study. UC, usual care; WBI, web-based intervention.
Take home figure
Take home figure
Main results of the first randomized controlled trial supporting the efficacy of a web-based intervention for reducing psychosocial distress vs. usual care in patients with an implantable cardioverter-defibrillator (ICD; age 18–75 years). Change over time (estimated marginal means, 95% confidence limits) in the primary outcome (psychosocial well-being) was neutral, although there was a non-significant trend in the expected direction. Significantly superior efficacy of web-based intervention over usual care was seen for secondary outcomes (Selection: subscales of the Hospital Anxiety and Depression Scale, HADS); CAQ, Cardiac Anxiety Questionnaire; SF-36, 36-Item Short Form Survey; †  P < 0.10, *P < 0.05, **P < 0.01; P-values not corrected for multiple testing.
https://www.ncbi.nlm.nih.gov/pmc/articles/instance/9597328/bin/eurheartj_41_11_1203_f3.jpg

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Source: PubMed

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