E-Compared-CH: Comparative Effectiveness Research on Internet-based Depression Treatment - Swiss Trial (E-COMPARED_CH)
European Comparative Effectiveness Research on Internet-based Depression Treatment - Swiss Trial
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Background
Depression is a common mental disorder with a negative impact on mental well-being, quality of life, and social and work-related functioning both in the short and longer term. Additionally, depression is associated with increased morbidity, mortality, health care utilization and health care costs. On a population level, depression is one of the most costly diseases. The economic costs of depression were estimated at €136.3 billion (EU25) in 2010 in the EU and are still rising. European health care systems face the challenge of improving access to cost-effective treatments while simultaneously working to sustain budgetary stability in times of economic austerity.
Internet-based depression treatment appears a very promising alternative to current routine depression treatment strategies. Meta-analyses have demonstrated the clinical effectiveness and potential cost-effectiveness of Internet-based treatment for depression in controlled research setting. Internet-based treatment thus has the potential to keep depression treatment affordable, as it enables mental health care providers to reach out to large populations needing depression treatment at a better cost-effectiveness than those of standard treatment as usual (TAU), but with similar levels of clinical efficacy and quality of care. The trials will be conducted in 8 European countries.
Objective
To compare the clinical and cost-effectiveness of blended CBT and TAU in secondary care
Methods
In Switzerland, a randomized-controlled trial will be carried out in secondary care, comparing the clinical and cost-effectiveness of CBT and TAU for adults with major depressive disorder (MDD). Respondents will be followed until 12 months after baseline (measures will be taken at BL, 12 weeks, 18 weeks, 6 months and 12 months).
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Bern, Suíça, 3014
- Department of Clinical Psychology and Psychotherapy
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Zurich
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Kilchberg, Zurich, Suíça, 8802
- Sanatorium Kilchberg
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Being 18 years of age or older
- Meet DSM-IV diagnostic criteria for MDD confirmed by MINI International Neuropsychiatric Interview version 5.0
- Informed Consent
- Having access to a PC and Internet connection
- Having a Smartphone that is compatible with the mobile component of the intervention
- Understanding of the German language spoken and written
Exclusion Criteria
- Current high risk for suicide according to the MINI Interview section C
- Serious psychiatric co-morbidity: substance dependence, bipolar affective disorder, psychotic illness, obsessive compulsive disorder, as established at the MINI interview
- Currently receiving psychological treatment for depression
- Being unable to comprehend the spoken and written language (German)
- Not having access to a PC and fast Internet connection (i.e. broadband or comparable).
- Not having a Smartphone that is compatible with the mobile component of the intervention that is offered or not willing to carry a Smartphone during the duration of treatment
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: Blended CBT
Internet based blended CBT depression treatment combines individual face-to-face cognitive behavioural therapy (CBT) with CBT delivered through an Internet based treatment platform with mobile phone components.
The core components of the CBT treatment are: (1) psychoeducation, (2) behavioural activation, (3) cognitive restructuring, and (4) relapse prevention.
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Internet based blended CBT depression treatment combines individual face-to-face cognitive behavioural therapy (CBT) with CBT delivered through an Internet based treatment platform with mobile phone components.
The core components of the CBT treatment are: (1) psychoeducation, (2) behavioural activation, (3) cognitive restructuring, and (4) relapse prevention.
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Comparador Ativo: Treatment as usual
Treatment as usual (TAU) is defined as the routine care that subjects receive when they are diagnosed with depression in the secondary care system.
The investigators will not interfere with treatment as usual but they will monitor carefully which health care services are utilized by usual care patients using patient records and through self-report.
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Treatment as usual (TAU) is defined as the routine care that subjects receive when they are diagnosed with depression in the secondary care system.
The investigators will not interfere with treatment as usual but they will monitor carefully which health care services are utilized by usual care patients using patient records and through self-report.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
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Patient Health Questionnaire-9 (PHQ-9)
Prazo: 18 weeks
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18 weeks
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Medidas de resultados secundários
Medida de resultado |
Prazo |
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Assessment of Quality of Life (AQoL-6D)
Prazo: Baseline, 12 weeks, 18 weeks, 6 months, and 12 months
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Baseline, 12 weeks, 18 weeks, 6 months, and 12 months
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Quick Inventory of Depressive Symptomatology Self-Report (QIDS-16-SR)
Prazo: Baseline, 12 weeks, 18 weeks, 6 months, and 12 months
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Baseline, 12 weeks, 18 weeks, 6 months, and 12 months
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MINI International Neuropsychiatric Interview (M.I.N.I; Ackenheil et al., 1999)
Prazo: Baseline, 18 weeks, and 12 months
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Baseline, 18 weeks, and 12 months
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EuroQoL (EQ-5D-5L; Herdman et al., 2011)
Prazo: Baseline, 12 weeks, 18 weeks, 6 months, and 12 months
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Baseline, 12 weeks, 18 weeks, 6 months, and 12 months
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Questionnaires on Costs Associated with Psychiatric Illness (TiC-P; Hakkaart-van Rooijen, van Straten, Donker, Tiemens, 2002)
Prazo: Baseline, 12 weeks, 18 weeks, 6 months, and 12 months
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Baseline, 12 weeks, 18 weeks, 6 months, and 12 months
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Client Satisfaction Questionnaire (CSQ-8; Nguyen, Attkinson, & Stegner, 1983)
Prazo: 12 weeks, and 18 weeks
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12 weeks, and 18 weeks
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System Usability Scale (SUS; Brooke, 1996)
Prazo: 12 weeks, and 18 weeks
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12 weeks, and 18 weeks
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Patient Health Questionnaire-9 (PHQ-9)
Prazo: Baseline, 12 weeks, 6 months, and 12 months
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Baseline, 12 weeks, 6 months, and 12 months
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Thomas Berger, PhD, University of Bern
Publicações e links úteis
Publicações Gerais
- van Genugten CR, Schuurmans J, Hoogendoorn AW, Araya R, Andersson G, Banos R, Botella C, Cerga Pashoja A, Cieslak R, Ebert DD, Garcia-Palacios A, Hazo JB, Herrero R, Holtzmann J, Kemmeren L, Kleiboer A, Krieger T, Smoktunowicz E, Titzler I, Topooco N, Urech A, Smit JH, Riper H. Examining the Theoretical Framework of Behavioral Activation for Major Depressive Disorder: Smartphone-Based Ecological Momentary Assessment Study. JMIR Ment Health. 2021 Dec 6;8(12):e32007. doi: 10.2196/32007.
- Kleiboer A, Smit J, Bosmans J, Ruwaard J, Andersson G, Topooco N, Berger T, Krieger T, Botella C, Banos R, Chevreul K, Araya R, Cerga-Pashoja A, Cieslak R, Rogala A, Vis C, Draisma S, van Schaik A, Kemmeren L, Ebert D, Berking M, Funk B, Cuijpers P, Riper H. 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. Trials. 2016 Aug 3;17(1):387. doi: 10.1186/s13063-016-1511-1.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 001/15
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