title: E-health to manage distress in patients with an implantable cardioverter-defibrillator: primary results of the WEBCARE trial.
abstract: 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.
  
  
  BACKGROUND
  clinicaltrials.gov. Identifier: NCT00895700.
authors.affiliation: From the CoRPS-Department of Medical and Clinical Psychology (M.H., J.D., V.R.M.S., KC.v.d.B., S.S.P.), Tilburg University, the Netherlands; Departmentof Clinical Psychology (P.C., L.W.), Vrije University, Amsterdam, the Netherlands; Department of Cardiology (P.H.v.d.V.), Catharina Hospital, Eindhoven, the Netherlands; Department of Cardiology (J.-.P.H.), Onze Lieve Vrouwe Gasthuis Hospital, Amsterdam, the Netherlands; Department of Cardiology (L.B.), Canisius-Wilhelmina Hospital, Nijmegen, the Netherlands; Department of Cardiology (S.S.D.V.), Vlietland Hospital, Schiedam, the Netherlands; Department of Cardiology (M.A.), Amphia Hospital, Breda, the Netherlands; Department of Cardiology (D.A.M.J.T., S.S.P.), Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands; Department of Psychology (S.S.P.), University of Southern Denmark, Odense, Denmark; and Department of Cardiology (S.S.P.), Odense University Hospital, Odense, Denmark.
authors.forename: Mirela
authors.initials: M
authors.lastname: Habibović
authors.forename: Johan
authors.initials: J
authors.lastname: Denollet
authors.forename: Pim
authors.initials: P
authors.lastname: Cuijpers
authors.forename: Viola R M
authors.initials: VR
authors.lastname: Spek
authors.forename: Krista C
authors.initials: KC
authors.lastname: van den Broek
authors.forename: Lisanne
authors.initials: L
authors.lastname: Warmerdam
authors.forename: Pepijn H
authors.initials: PH
authors.lastname: van der Voort
authors.forename: Jean-Paul
authors.initials: JP
authors.lastname: Herrman
authors.forename: Leon
authors.initials: L
authors.lastname: Bouwels
authors.forename: Suzanne S D
authors.initials: SS
authors.lastname: Valk
authors.forename: Marco
authors.initials: M
authors.lastname: Alings
authors.forename: Dominic A M J
authors.initials: DA
authors.lastname: Theuns
authors.forename: Susanne S
authors.initials: SS
authors.lastname: Pedersen
mesh_terms: D001007:Anxiety / Q000453:epidemiology / Q000628:therapy; D015928:Cognitive Behavioral Therapy / Q000379:methods*; D017147:Defibrillators, Implantable / Q000523:psychology*; D003863:Depression / Q000453:epidemiology / Q000628:therapy; D006801:Humans; D008297:Male; D008875:Middle Aged; D010342:Patient Acceptance of Health Care / Q000523:psychology; D011569:Psychiatric Status Rating Scales; D011788:Quality of Life / Q000523:psychology; D013315:Stress, Psychological / Q000209:etiology / Q000517:prevention & control* / Q000523:psychology; D011795:Surveys and Questionnaires; D017216:Telemedicine / Q000379:methods*