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RETRACTED ARTICLE: WELL.ME - Wellbeing therapy based on real-time personalized mobile architecture, vs. cognitive therapy, to reduce psychological distress and promote healthy lifestyle in cardiovascular disease patients: study protocol for a randomized controlled trial

  • Angelo Compare
  • Vassilis Kouloulias
  • Vontas Apostolos
  • Wendy Moreno Peña
  • Enrico Molinari
  • Enzo Grossi
  • Efstathopoulos Efstathios
  • Michele Carenini
Study protocol

Abstract

Background

There is compelling evidence that psychological factors may have the same or even greater impact on the possibility of adverse events on cardiac diseases (CD) than other traditional clinical risk factors. Anxiety and depression are predictors of short- and long-term adverse outcomes, increased risk for higher rates of in-hospital complications, re-infarction, malignant arrhythmias, and mortality in CD patients. Despite researchers finding that cognitive behavior therapy (CBT) reduced depressive and anxiety symptoms, the fact that such results are maintained only in the short term and the lack of maintenance of the long-term affects the absence of changes in lifestyles, preventing the possibility of a wide generalization of results. Recently wellbeing therapy (WBT) has been proposed as a useful approach to improve healthy lifestyle behaviors and reduce psychological distress.

Methods/design

The present randomized controlled study will test WBT, in comparison with CBT, as far as the reduction of symptoms of depression, anxiety and psychological distress, and the improvement of lifestyle behaviors and quality of life in cardiac patients are concerned. Moreover, innovations in communication technologies allow patients to be constantly followed in real life. Therefore WBT based on personalized mobile technology will allow the testing of its effectiveness in comparison with usual WBT.

Discussion

The present study is a large outpatient study on the treatment of co-morbid depression, anxiety, and psychological distress in cardiac patients. The most important issues of this study are its randomized design, the focus on promotion of health-related behaviors, and the use of innovative technologies supporting patients’ wellbeing in real life and in a continuous way. First results are expected in 2012.

Trial registration

ClinicalTrials.gov Identifier: NCT01543815.

Keywords

Anxiety Depression Psychological distress Cognitive behavior therapy Wellbeing therapy Mobile technology Cardiac disease 

Abbreviations

CBT

Cognitive behavioral therapy

CD

Cardiac disease

CHD

Coronary heart disease

CI

Confidence interval

CSM-IV

Diagnostic and Statistical Manual, 4th edition

DCPR

Diagnostic Criteria for Psychosomatic Research

GAD-7

Generalized Anxiety Disorder 7

GP

General practitioner

HF

Heart failure

HRQoL

Health-related quality of life

M.I.N.I.

Mini International Neuropsychiatric Interview

MobWBT

WBT version based on personalized mobile technology

NYHA

New York Heart association

PGWBI

Psychological General Wellbeing Index

LHFQ

Minnesota Living with Heart Failure Questionnaire

OR

Odds ratio

PHQ-9

Patient Health Questionnaire 9

PSI

Psychosocial Index

PWB

Psychological Wellbeing Scale

SPSS

Statistical Package for Social Sciences

UC

Usual care

WBT

Well-being therapy.

Notes

Supplementary material

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Authors’ original file for figure 1
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Authors’ original file for figure 2
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Authors’ original file for figure 3

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Copyright information

© Compare et al.; licensee BioMed Central Ltd. 2012

This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Authors and Affiliations

  • Angelo Compare
    • 1
  • Vassilis Kouloulias
    • 2
  • Vontas Apostolos
    • 3
  • Wendy Moreno Peña
    • 4
  • Enrico Molinari
    • 5
  • Enzo Grossi
    • 6
  • Efstathopoulos Efstathios
    • 2
  • Michele Carenini
    • 7
  1. 1.Human Factors and Technologies for Health - HTC Centre; Dept. of Human and Social SciencesUniversity of BergamoBergamoItaly
  2. 2.Medical School, National University of AthensAthensGreece
  3. 3.Technopolis ICT Business ParkThessalonikiGreece
  4. 4.SOROS GABINETE, Socia ProgramasEuropeosEuropeSpain
  5. 5.Istituto Auxologico ItalianoCatholic University of MilanMilanItaly
  6. 6.Medical DepartmentBracco SpA; IULM - UniversityFondazione BraccoItaly
  7. 7.NoemaLife SpaBolognaItaly

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