Trial reportEuropean heart journal2020
Efficacy of a web-based intervention for improving psychosocial well-being in patients with implantable cardioverter-defibrillators: the randomized controlled ICD-FORUM trial.
Trial report in European heart journal, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 15 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Remote Care for Reducing Cardiac Fear, Fear of Dying, Depression, and Increasing Quality of Life in ICD-Patients With Cardiac Insufficiency/at Risk for Fatal Cardiac Arrhythmia.
Efficacy of a Mindfulness-Based Intervention on Resilience, Perceived Stress, Anxiety, and Depression, in Patients With Cardiovascular Implantable Electronic Device: A Mixed-Methods Research
Who cites it
15 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Psychological eHealth Interventions for Patients With Cardiovascular Diseases: Systematic Review and Meta-Analysis.Journal of medical Internet research · 2025Pooled it
- The Influence of Hybrid Comprehensive Telerehabilitation on Anxiety in Heart Failure Patients: The TELEREH-HF Randomized Clinical Trial.Journal of clinical psychology in medical settings · 2024Trial
- High social support is associated with reduced cardiac events in patients following ICD/CRT-D implantation: a one-year follow-up study in China.BMC psychology · 2025Article
- Psychological Interventions for Reducing Distress in Patients with Cardiac Arrhythmias.Current cardiology reports · 2025Review
- Individualized Electronic Patient-Reported Outcome Measures As a Communication Aid in Outpatient Cardiology Care: A Study Protocol.CJC open · 2025Article
- Depression and anxiety in patients receiving an implantable cardioverter defibrillator with or without cardiac resynchronization therapy.Journal of geriatric cardiology : JGC · 2025Article
- Patient informed consent, ethical and legal considerations in the context of digital vulnerability with smart, cardiac implantable electronic devices.PLOS digital health · 2024Review
- Mind-body internet and mobile-based interventions for depression and anxiety in adults with chronic physical conditions: A systematic review of RCTs.PLOS digital health · 2024Article
- Sex and gender reporting in RCTs of internet and mobile-based interventions for depression and anxiety in chronic conditions: A secondary analysis of a systematic review.PLOS mental health · 2024Article
- Addressing PTSD in Implantable Cardioverter Defibrillator Patients: State-of-the-Art Management of ICD Shock and PTSD.Current cardiology reports · 2023Review
- Defibrillator exchange in the elderly.Heart rhythm O2 · 2023Article
- Efficacy of digital health interventions on depression and anxiety in patients with cardiac disease: a systematic review and meta-analysisEuropean heart journal. Digital health · 2022Review
- Can Religiosity and Social Support Explain Effects of Trait Emotional Intelligence on Health-Related Quality of Life: A Cross-Cultural Study.Journal of religion and health · 2022Article
- Changes in quality of life, depression, general anxiety, and heart-focused anxiety after defibrillator implantation.ESC heart failure · 2021Article
- Cardiac sympathetic denervation and mental health.Autonomic neuroscience : basic & clinical · 2021Article
Corrections and comments
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Authors and funding
13 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimsAnxiety, 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
resultsThis 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).
conclusionAlthough 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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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.