Aim and Background: Although implantable cardioverter defibrillators (ICD) save lives, many
ICD-patients experience psychosocial complications such as anxiety disorders, depression and
reduced quality of life after ICD-implantation. A recent review has indicated great potential
for psychosocial interventions to reduce anxiety and to increase exercise capacity of
ICD-patients. In a previous study, the investigators showed that mailed information about
technical, medical and psychological effects of ICD plus phone counseling are effective
interventions for reducing anxiety, psychological distress and increasing QoL in ICD-patients
< 65 years. In a pilot study the investigators also documented promising effects of an
internet based intervention with similar content.
Method: In a prospective, multicenter, multidisciplinary, half-open, part-randomized,
controlled clinical trial N = 200 patients with an ICD will either receive medical care as
usual or additionally attend a psychosocial prevention program via remote care. Psychosocial
support will be provided utilizing the advantages of the internet. Thus, patient-centered
support will be offered independent from time and location.
Outcome measures are psychometric data (questionnaires on cardiac fear, etc.), cardiac
functioning, and clinical status which will be assessed up to 1 week before ICD-implantation
(T0), in week 1 (T1) and within one week after (T2) the 6-weeks prevention program, and 12
months after T0 (T3). Furthermore, demographic data, personality characteristics,
expectations, physiology, pro-inflammatory cytokines and cardiac status will be assessed as
mediating or moderating variables.
Hypotheses: A web-based psychosocial intervention in addition to medical care as usual leads
to increased QoL and reduced anxiety and depression. Secondary goals are the identification
of psychosocial and medical predictors, mediators, and moderators of treatment efficacy.
Moreover, differences between patients with ICDs implanted for primary vs. secondary
prevention will be explored.
Conclusion: This project will evaluate the feasibility and efficacy of an internet based
intervention for ICD-patients. Furthermore, the investigators aim at identifying predictors
and mediators of treatment outcome. This will improve interdisciplinary care for
ICD-patients; further applications for other cardiovascular disorders as well as preventive
programs for heart failure seem possible.