E-Compared-CH: Comparative Effectiveness Research on Internet-based Depression Treatment - Swiss Trial (E-COMPARED_CH)
20 de septiembre de 2017 actualizado por: University of Bern
European Comparative Effectiveness Research on Internet-based Depression Treatment - Swiss Trial
To compare the clinical and cost-effectiveness of blended Cognitive Behavioural Therapy (CBT) for adults with major depressive disorder (MDD) with treatment as usual (TAU) in Swiss patients in secondary care
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
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 estudio
Intervencionista
Inscripción (Actual)
50
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Bern, Suiza, 3014
- Department of Clinical Psychology and Psychotherapy
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Zurich
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Kilchberg, Zurich, Suiza, 8802
- Sanatorium Kilchberg
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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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 activo: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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Patient Health Questionnaire-9 (PHQ-9)
Periodo de tiempo: 18 weeks
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18 weeks
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
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Assessment of Quality of Life (AQoL-6D)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 12 weeks, and 18 weeks
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12 weeks, and 18 weeks
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System Usability Scale (SUS; Brooke, 1996)
Periodo de tiempo: 12 weeks, and 18 weeks
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12 weeks, and 18 weeks
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Patient Health Questionnaire-9 (PHQ-9)
Periodo de tiempo: 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
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Thomas Berger, PhD, University of Bern
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de marzo de 2015
Finalización primaria (Actual)
1 de julio de 2017
Finalización del estudio (Actual)
1 de julio de 2017
Fechas de registro del estudio
Enviado por primera vez
2 de abril de 2015
Primero enviado que cumplió con los criterios de control de calidad
2 de abril de 2015
Publicado por primera vez (Estimar)
7 de abril de 2015
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
21 de septiembre de 2017
Última actualización enviada que cumplió con los criterios de control de calidad
20 de septiembre de 2017
Última verificación
1 de septiembre de 2017
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 001/15
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