E-Health to manage distress in patients with an implantable cardioverter-defibrillator: Primary results of the WEBCARE trial

M. Habibovic, J. Denollet, P. Cuijpers, V.R. Spek, K.C. van den Broek, E.H. Warmerdam, P.H. van der Voort, J.P. Herrman, L. Bouwels, S.S.D. Valk, M. Alings, D.A.M.J. Theuns, S.S. Pedersen

Research output: Contribution to JournalArticleAcademicpeer-review

Abstract

Objective: 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.
Original languageEnglish
Pages (from-to)593-602
Number of pages10
JournalPsychosomatic Medicine
Volume76
Issue number8
DOIs
Publication statusPublished - 2014

Fingerprint

Implantable Defibrillators
Anxiety
Health
Quality of Life
Depression
Shock
Equipment and Supplies
Cognitive Therapy
Netherlands
Outcome Assessment (Health Care)
Therapeutics

Cite this

Habibovic, M. ; Denollet, J. ; Cuijpers, P. ; Spek, V.R. ; van den Broek, K.C. ; Warmerdam, E.H. ; van der Voort, P.H. ; Herrman, J.P. ; Bouwels, L. ; Valk, S.S.D. ; Alings, M. ; Theuns, D.A.M.J. ; Pedersen, S.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{9e07b82c91c44ab78a07118f4c7f5e5a,
title = "E-Health to manage distress in patients with an implantable cardioverter-defibrillator: Primary results of the WEBCARE trial",
abstract = "Objective: 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.",
author = "M. Habibovic and J. Denollet and P. Cuijpers and V.R. Spek and {van den Broek}, K.C. and E.H. Warmerdam and {van der Voort}, P.H. and J.P. Herrman and L. Bouwels and S.S.D. Valk and M. Alings and D.A.M.J. Theuns and S.S. Pedersen",
year = "2014",
doi = "10.1097/PSY.0000000000000096",
language = "English",
volume = "76",
pages = "593--602",
journal = "Psychosomatic Medicine",
issn = "0033-3174",
publisher = "Lippincott Williams and Wilkins",
number = "8",

}

Habibovic, M, Denollet, J, Cuijpers, P, Spek, VR, van den Broek, KC, Warmerdam, EH, van der Voort, PH, Herrman, JP, 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, M.; Denollet, J.; Cuijpers, P.; Spek, V.R.; van den Broek, K.C.; Warmerdam, E.H.; van der Voort, P.H.; Herrman, J.P.; Bouwels, L.; Valk, S.S.D.; Alings, M.; Theuns, D.A.M.J.; Pedersen, S.S.

In: Psychosomatic Medicine, Vol. 76, No. 8, 2014, p. 593-602.

Research output: Contribution to JournalArticleAcademicpeer-review

TY - JOUR

T1 - E-Health to manage distress in patients with an implantable cardioverter-defibrillator: Primary results of the WEBCARE trial

AU - Habibovic, M.

AU - Denollet, J.

AU - Cuijpers, P.

AU - Spek, V.R.

AU - van den Broek, K.C.

AU - Warmerdam, E.H.

AU - van der Voort, P.H.

AU - Herrman, J.P.

AU - Bouwels, L.

AU - Valk, S.S.D.

AU - Alings, M.

AU - Theuns, D.A.M.J.

AU - Pedersen, S.S.

PY - 2014

Y1 - 2014

N2 - Objective: 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.

AB - Objective: 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.

U2 - 10.1097/PSY.0000000000000096

DO - 10.1097/PSY.0000000000000096

M3 - Article

VL - 76

SP - 593

EP - 602

JO - Psychosomatic Medicine

JF - Psychosomatic Medicine

SN - 0033-3174

IS - 8

ER -