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European COMPARative Effectiveness research on blended Depression treatment versus treatment-as-usual (E-COMPARED): study protocol for a randomized controlled, non-inferiority trial in eight European countries

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  • معلومة اضافية
    • بيانات النشر:
      Linköpings universitet, Psykologi
      Linköpings universitet, Filosofiska fakulteten
      Linköpings universitet, Institutet för handikappvetenskap (IHV)
      Section Clinical Psychology, Vrije Universiteit Amsterdam and EMGO+ Institute for Health Care and Research, Amsterdam, The Netherlands
      Department of Psychiatry, VU University Medical Centre and EMGO+ Institute for Health Care and Research, Amsterdam, The Netherlands
      Department of Health Sciences, Vrije Universiteit Amsterdam and EMGO+ Institute for Health and Care Research, Amsterdam, The Netherlands
      Department of Clinical Neuroscience, Psychiatry Section, Karolinska Institutet
      Department of Clinical Psychology and Psychotherapy, University of Bern, Bern, Switzerland
      Department of Psychology and Technology, Jaume University, Castellon, Spain.; Department of Personalidad, Evaluación y Tratamiento Psicológicos, Valencia, Spain
      Department of Personalidad, Evaluación y Tratamiento Psicológicos, Valencia, Spain
      URC-ECO, Ile-de-France (AP-HP), Paris, France
      Department of Population Health, London School of Hygiene and Tropical Medicine, London, UK
      Department of Psychology, Szkoła Wyzsza Psychologii Społeczne, University of Social Sciences and Humanities, Warsaw, Poland
      Section Clinical Psychology, Vrije Universiteit Amsterdam and EMGO+ Institute for Health Care and Research, Van der Boechorststraat 1, 1081 BT, Amsterdam, The Netherlands
      Department of Clinical Psychology, Philipps University, Marburg, Germany
      Institut für elektronische Geschäftsprozesse, Leuphana University Lüneburg, Lüneburg, Germany
      Section Clinical Psychology, Vrije Universiteit Amsterdam and EMGO+ Institute for Health Care and Research, Van der Boechorststraat 1, 1081 BT, Amsterdam, The Netherlands.; Department of Psychiatry, VU University Medical Centre and EMGO+ Institute for Health Care and Research, Amsterdam, The Netherlands
      London
    • الموضوع:
      2016
    • Collection:
      Linköping University Electronic Press (LiU E-Press)
    • نبذة مختصرة :
      Background: Effective, accessible, and affordable depression treatment is of high importance considering the large personal and economic burden of depression. Internet-based treatment is considered a promising clinical and cost-effective alternative to current routine depression treatment strategies such as face-to-face psychotherapy. However, it is not clear whether research findings translate to routine clinical practice such as primary or specialized mental health care. The E-COMPARED project aims to gain knowledge on the clinical and cost-effectiveness of blended depression treatment compared to treatment-as-usual in routine care. Methods/design: E-COMPARED will employ a pragmatic, multinational, randomized controlled, non-inferiority trial in eight European countries. Adults diagnosed with major depressive disorder (MDD) will be recruited in primary care (Germany, Poland, Spain, Sweden, and the United Kingdom) or specialized mental health care (France, The Netherlands, and Switzerland). Regular care for depression is compared to "blended" service delivery combining mobile and Internet technologies with face-to-face treatment in one treatment protocol. Participants will be followed up at 3, 6, and 12 months after baseline to determine clinical improvements in symptoms of depression (primary outcome: Patient Health Questionnaire-9), remission of depression, and cost-effectiveness. Main analyses will be conducted on the pooled data from the eight countries (n = 1200 in total, 150 participants in each country). Discussion: The E-COMPARED project will provide mental health care stakeholders with evidence-based information and recommendations on the clinical and cost-effectiveness of blended depression treatment. Trial Registration: France: ClinicalTrials.gov NCT02542891 . Registered on 4 September 2015; Germany: German Clinical Trials Register DRKS00006866 . Registered on 2 December 2014; The Netherlands: Netherlands Trials Register NTR4962 . Registered on 5 January 2015; Poland: ClinicalTrials.Gov NCT02389660 . ...
    • File Description:
      application/pdf
    • Relation:
      Trials, 2016, 17:1; orcid:0000-0003-4753-6745; orcid:0000-0001-5972-3041; http://urn.kb.se/resolve?urn=urn:nbn:se:liu:diva-130960; PMID 27488181; ISI:000381077400002
    • الرقم المعرف:
      10.1186/s13063-016-1511-1
    • الدخول الالكتروني :
      http://urn.kb.se/resolve?urn=urn:nbn:se:liu:diva-130960
      https://doi.org/10.1186/s13063-016-1511-1
    • Rights:
      info:eu-repo/semantics/openAccess
    • الرقم المعرف:
      edsbas.90302244