WEB-based distress management program for implantable CARdioverter dEfibrillator patients.

The implantable cardioverter defibrillator (ICD) constitutes the treatment of
choice in patients who have experienced life-threatening cardiac arrhythmias
and in patients at risk for these cardiac arrhythmias. Several clinical trials
have shown that the ICD is superior to antiarrhythmic drugs in the prevention
of sudden cardiac death. The ICD can terminate life-threatening arrhythmias by
antitachycardia pacing or shocks.

Despite the medical benefits of ICD treatment, 25-35% of ICD patients
experience clinical levels of anxiety and poor quality of life. Adaptation
problems have several causes, including the experience of resuscitation and the
unpredictable reoccurrence of life-threatening arrhythmias and ICD therapies.
For these patients, behavioral intervention may be warranted in order to reduce
distress and secondary outcomes, such as avoidance behavior, physical
inactivity, and poor quality of life. In addition, preliminary evidence
indicates that emotional distress may precipitate life-threatening arrhythmic
events, with a successful reduction in distress potentially leading to a
decrease in these arrhythmias. Given the exponential rise in ICD implantations
and the projected increase in the future, knowledge of the efficacy of
behavioral interventions is important in order to optimize clinical management
of these patients.

The general objective of the intervention trial will be to evaluate the effect
of this web-based behavioral intervention on psychological outcomes (i.e.,
anxiety and quality of life), physiological parameters (i.e., ventricular
arrhythmias and salivary cortisol levels), and self-care and health-care
utilization. In addition, the potential moderating influence of psychological
(i.e., personality and positive affect) and clinical (i.e., cardiac
synchronization therapy) factors on the effectiveness of the intervention will
be determined. Finally, the cost-effectiveness of the intervention will be
evaluated.

Specific objectives:

Primary
1. To investigate whether the web-based intervention is superior to usual care
in terms of reducing anxiety and ICD concerns as well as improving ICD
acceptance and quality of life.
2. To investigate whether the web-based intervention is cost-effective and
leads to a reduction in health-care utilization in the intervention group as
compared to the usual care group.

Secondary
1. To examine whether psychological (i.e., Type D personality and positive
affect) and clinical factors (i.e., cardiac resynchronization therapy) moderate
the effect of the intervention, with a view to developing risk profiles of
patients who are less likely to benefit from the intervention.

Exploratory
1. To explore whether the web-based intervention influences physiological
parameters (i.e., ventricular arrhythmias and the cortisol awakening response).

The study design is a prospective, multi-center, multi-disciplinary, randomized
controlled web-based behavioral intervention trial, with usual care comprising
the comparison group.

Standardized and validated questionnaires will be administered at four time
points. At baseline (i.e., 1 day prior to implantation and randomization), 3
months (i.e., at the end of the intervention), and 6 and 12 months. Salivary
cortisol will be assessed at the majority of these time points. Information on
the occurrence of life-threatening arrhythmias will be obtained from the
patients' medical records.

The proposed behavioral intervention will be web-based, comprising 8 modules
with a duration of 3 months starting two weeks after ICD implantation. The main
components include education about the ICD, cognitive restructuring and
problem-solving skills, and relaxation training.

Given that a web-based behavioral intervention is provided to the treatment
arm, and no invasive medical procedures nor withholding medical treatment are
done, there are no risks associated with participation in the study. The burden
to patients is comprised of completing a set of standardized and validated
questionnaires at 4 time points and providing saliva samples at 3 time points.
It is estimated that it will take 45 minutes to complete the set of
questionnaires at each time point. No extra scheduled visits to the hospitals
are nessary for patients participating in the study.