E-health to manage distress in patients with an implantable cardioverter-defibrillator

Primary results of the WEBCARE trial

Mirela Habibovic, J. Denollet, Pim Cuijpers, Viola R. M. Spek, K.C. van den Broek, Lisanne Warmerdam, Pepijn H. van der Voort, Jean-Paul Herrman, Leon Bouwels, Suzanne S. D. Valk, Marco Alings, Dominic A. M. J. Theuns, Susanne S. Pedersen

Research output: Contribution to journalArticleScientificpeer-review

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.
Original languageEnglish
Pages (from-to)593-602
JournalPsychosomatic Medicine
Volume76
Issue number8
DOIs
Publication statusPublished - Oct 2014

Keywords

  • implantable cardioverter-defibrillator
  • anxiety
  • depression
  • quality of life
  • Web-based behavioral treatment

Cite this

Habibovic, Mirela ; Denollet, J. ; Cuijpers, Pim ; Spek, Viola R. M. ; van den Broek, K.C. ; Warmerdam, Lisanne ; van der Voort, Pepijn H. ; Herrman, Jean-Paul ; Bouwels, Leon ; Valk, Suzanne S. D. ; Alings, Marco ; Theuns, Dominic A. M. J. ; Pedersen, Susanne S. / E-health to manage distress in patients with an implantable cardioverter-defibrillator : Primary results of the WEBCARE trial. In: Psychosomatic Medicine. 2014 ; Vol. 76, No. 8. pp. 593-602.
@article{7eb0a4c72d0e43ff8f7bad2e6968efec,
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.",
keywords = "implantable cardioverter-defibrillator, anxiety, depression, quality of life, Web-based behavioral treatment",
author = "Mirela Habibovic and J. Denollet and Pim Cuijpers and Spek, {Viola R. M.} and {van den Broek}, K.C. and Lisanne Warmerdam and {van der Voort}, {Pepijn H.} and Jean-Paul Herrman and Leon Bouwels and Valk, {Suzanne S. D.} and Marco Alings and Theuns, {Dominic A. M. J.} and Pedersen, {Susanne S.}",
year = "2014",
month = "10",
doi = "10.1097/PSY.0000000000000096",
language = "English",
volume = "76",
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Habibovic, M, Denollet, J, Cuijpers, P, Spek, VRM, van den Broek, KC, Warmerdam, L, van der Voort, PH, Herrman, J-P, Bouwels, L, Valk, SSD, Alings, M, Theuns, DAMJ & Pedersen, SS 2014, 'E-health to manage distress in patients with an implantable cardioverter-defibrillator: Primary results of the WEBCARE trial', Psychosomatic Medicine, vol. 76, no. 8, pp. 593-602. https://doi.org/10.1097/PSY.0000000000000096

E-health to manage distress in patients with an implantable cardioverter-defibrillator : Primary results of the WEBCARE trial. / Habibovic, Mirela; Denollet, J.; Cuijpers, Pim; Spek, Viola R. M.; van den Broek, K.C.; Warmerdam, Lisanne; van der Voort, Pepijn H.; Herrman, Jean-Paul; Bouwels, Leon; Valk, Suzanne S. D.; Alings, Marco; Theuns, Dominic A. M. J.; Pedersen, Susanne S.

In: Psychosomatic Medicine, Vol. 76, No. 8, 10.2014, p. 593-602.

Research output: Contribution to journalArticleScientificpeer-review

TY - JOUR

T1 - E-health to manage distress in patients with an implantable cardioverter-defibrillator

T2 - Primary results of the WEBCARE trial

AU - Habibovic, Mirela

AU - Denollet, J.

AU - Cuijpers, Pim

AU - Spek, Viola R. M.

AU - van den Broek, K.C.

AU - Warmerdam, Lisanne

AU - van der Voort, Pepijn H.

AU - Herrman, Jean-Paul

AU - Bouwels, Leon

AU - Valk, Suzanne S. D.

AU - Alings, Marco

AU - Theuns, Dominic A. M. J.

AU - Pedersen, Susanne S.

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N2 - 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.

AB - 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.

KW - implantable cardioverter-defibrillator

KW - anxiety

KW - depression

KW - quality of life

KW - Web-based behavioral treatment

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