Efficacy of a web-based intervention for improving psychosocial well-being in patients with implantable cardioverter-defibrillators: the randomized controlled ICD-FORUM trial
Open accessAbstract
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.
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The absence of intervention effects on anxiety and depression mimics the results from the WEBCARE trial, but not from the ICD-FORUM trial, which found that a web-based intervention reduced anxiety and depression symptoms at 1 year follow-up compared with usual care.
“The absence of intervention effects on anxiety and depression levels mimics the results from the WEBCARE trial,26 but not from the ICD-FORUM trial,25 which found that a web-based intervention reduced anxiety and depression symptoms at 1 year follow-up compared with usual care.”
From Efficacy of a web-based healthcare innovation to advance the quality of life and care of patients with an implantable cardioverter defibrillator (ACQUIRE-ICD): A randomized controlled trial (2023) · cites this paper as [25]
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Experimental — accuracy not yet measuredThe ICD-FORUM trial included only patients with distress, whereas ACQUIRE-ICD and WEBCARE targeted a broad scope of ICD patients, regardless of pre-intervention distress.
“Whereas the ICD-FORUM trial included only patients with distress, ACQUIRE-ICD and WEBCARE targeted a broad scope of ICD patients, regardless of pre-intervention distress.”
From Efficacy of a web-based healthcare innovation to advance the quality of life and care of patients with an implantable cardioverter defibrillator (ACQUIRE-ICD): A randomized controlled trial (2023) · cites this paper as [25]
The Methods (Setting and participants; page unavailable) confirm that ICD-FORUM required at least mildly increased psychosocial distress for inclusion. The Discussion describes one other ICD web-intervention trial as enrolling unselected patients, but our copy does not identify it as WEBCARE or establish the enrollment criteria of ACQUIRE-ICD. Those comparisons are therefore not fully supported by this source. (LLM, conf=0.84)
Experimental — accuracy not yet measuredThe null finding for the primary endpoint is in line with results from other RCTs of web-based interventions in ICD patients that also found neutral primary endpoints.
“this finding is in line with the results from other RCTs of web-based interventions in ICD patients that also found neutral primary endpoints albeit on anxiety and a composite outcome of psychosocial well-being, respectively.25,26”
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“The absence of intervention effects on anxiety and depression levels mimics the results from the WEBCARE trial, 26 but not from the ICD-FORUM trial, 25 which found that a web-based intervention reduced anxiety and depression symptoms at 1 year follow-up compared with usual care.”
Result
- Authors
- Schulz, S. M., Ritter, O., Zniva, R., Nordbeck, P., Wacker, C., Jack, M., Groschup, G., Deneke, T., Puppe, F., Ertl, G., Angermann, C., Störk, S., & Pauli, P.
- Affiliations
- Johannes Gutenberg University Mainz (DE)
- University of Würzburg (DE)
- Division of Cardiology, Department of Medicine, ANregiomed—Hospital Rothenburg ob der Tauber , Ansbacher Straße 131, BY, 91541 Rothenburg ob der Tauber, Germany
- Hospital Bad Wörishofen , Tannenbaum 2, BY, 86825 Bad Wörishofen, Germany
- Klinikum Aschaffenburg (DE)
- Department of Cardiology , Cardiovascular Centre GmbH, Schlossplatz 1, BY, 97616 Bad Neustadt a. d. Saale, Germany
- Corresponding author
- Schulz, Stefan M
- Pauli, Paul
- ORCID
- Venue
- European Heart Journal
- Publisher
- Oxford University Press (OUP)
- Published
- 2019-04-08
- Volume
- 41
- Issue
- 11
- Pages
- 1203-1211
- ISSN
- 0195-668X (ISSN-L)
- 1522-9645
- PMC
- PMC9597328
- OpenAlex
- W2936703182
- Cited by
- 35
- References
- 32
- Citations by year
- 2026: 1 · 2025: 11 · 2024: 4 · 2023: 6 · 2022: 5 · 2021: 6 · 2020: 1 · 2019: 1
- FWCI
- 3.67
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- European Heart Journal (publishedVersion, cc-by-nc)
- PubMed Central (publishedVersion, cc-by-nc)
- PubMed (publishedVersion)
- Funders
- Comprehensive Heart Failure Center
- Department of Medicine I
- Division of Rhythmology
- University Hospital Würzburg
- German Federal Ministry of Education and Research
- BMBF (01EO1004, 01EO1504)
- Topics
- Social Sciences › Psychology › Applied Psychology › Digital Mental Health Interventions
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Cardiac Health and Mental Health
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Telemedicine and Telehealth Implementation
- Keywords
- implantable cardioverter-defibrillator, online intervention, psychosocial well-being, anxiety, depression, quality of life, cognitive behavioral therapy, self-help groups, social support, usual care comparison, patient mobilization, self-management, life satisfaction, Hospital Anxiety and Depression Scale
- MeSH terms
- Internet-Based Intervention, Aged, Anxiety, Depression, Female, Humans, Male, Middle Aged, Quality of Life, Cognitive Behavioral Therapy, Defibrillators, Implantable
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