October 1, 2014Open Access
E-Health to Manage Distress in Patients With an Implantable Cardioverter-Defibrillator
Key Result
The WEBCARE Web-based behavioral treatment program did not significantly reduce anxiety compared to usual care at 3 months in patients with a first-time implantable cardioverter-defibrillator.
Study Design
Type
RCT (n=289)
Blinding
Single-blind (health care providers blinded)
Randomization
1:1 block randomization by computer
Multicenter
Yes
Structured PICO
Does a 12-week Web-based cognitive behavioral therapy program improve anxiety, depression, and quality of life in patients with a first-time ICD?
P
Population
289 patients aged 18 to 75 years receiving a first-time implantable cardioverter-defibrillator, followed for 3 months.
I
Intervention
WEBCARE: a 12-week fixed, six-lesson Web-based behavioral treatment based on the problem-solving principles of cognitive behavioral therapy.
C
Comparator
Usual care.
O
Outcome
Anxiety, depression, and health-related quality of life at 3-month follow-up.patient reported
A generic 12-week Web-based cognitive behavioral therapy program did not significantly improve anxiety, depression, or quality of life in patients receiving a first-time ICD.
Main Result
Mean Difference: 0.35
p-value: p=0.32
Limitations
- Selection bias toward highly educated men who might have been more motivated to participate
- Significant number of patients excluded or refused participation, jeopardizing generalizability
- Short follow-up period of 3 months precludes conclusions about long-term effects
- High attrition rate with only 23% of the intervention group completing all six lessons
Abstract
UNLABELLED: The Web-based distress management program for patients with an implantable cardioverter-defibrillator (ICD; WEBCARE) was developed to mitigate distress and enhance health-related quality of life in ICD patients. This study investigated the treatment effectiveness at 3-month follow-up for generic and disease-specific outcome measures. METHODS: Consecutive patients implanted with a first-time ICD from six hospitals in the Netherlands were randomized to either the "WEBCARE" or the "usual care" group. Patients in the WEBCARE group received a 12-week fixed, six-lesson behavioral treatment based on the problem-solving principles of cognitive behavioral therapy. RESULTS: Two hundred eighty-nine patients (85% response rate) were randomized. The prevalence of anxiety and depression ranged between 11% and 30% and 13% and 21%, respectively. No significant intervention effects were observed for anxiety (β = 0.35; p = .32), depression (β = -0.01; p = .98) or health-related quality of life (Mental Component Scale: β = 0.19; p = .86; Physical Component Scale: β = 0.58; p = .60) at 3 months, with effect sizes (Cohen d) being small (range, 0.06-0.13). There were also no significant group differences as measured with the disease-specific measures device acceptance (β = -0.37; p = .82), shock anxiety (β = 0.21; p = .70), and ICD-related concerns (β = -0.08; p = .90). No differences between treatment completers and noncompleters were observed on any of the measures. CONCLUSIONS: In this Web-based intervention trial, no significant intervention effects on anxiety, depression, health-related quality of life, device acceptance, shock anxiety, or ICD-related concerns were observed. A more patient tailored approach targeting the needs of different subsets of ICD patients may be warranted. TRIAL REGISTRATION: clinicaltrials.gov. Identifier: NCT00895700.