Lifestyle Modification Program for Patients With Chronic Pain Conditions (POSITAG)
Process-outcome-study in the Context of a Lifestyle Modification Program for Patients With Chronic Pain Conditions
In this observational study the effects of a Lifestyle Modification Program - offered as a semi-residential day care clinic - on pain, disability, quality of life and satisfaction with life will be investigated. Furthermore the influence of mindfulness, acceptance and coping, and acquired changes in lifestyle behaviors on the outcome after the program will be evaluated.
Effects will be measured after completion of the program (3 months), and at 6 and 12 months follow up after start of the program, i.e. each outcome measure will be taken 4 times within 12 months.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Essen, Alemania, 45276
- Department of Internal and Integrative Medicine, Kliniken Essen-Mitte
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- 18-78
- diagnosed with any chronic pain condition
- physical and mental ability to participate in the program and the study
- written informed consent
Exclusion Criteria:
- participation in any other clinical study focusing on psychological or behavioral intervention
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
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Lifestyle Modification
All patients with chronic pain conditions participate in a 8-weeks structured group program.
Detailed information on the mindfulness based program can be found in the publication by Paul, A. et al. "An Integrative Day Care Clinic for chronically ill patients: Concept and case presentation" in the European Journal of Integrative Medicine, 2012, 4(4):e455-e459.
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Modificación del estilo de vida
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Pain intensity
Periodo de tiempo: 3 months
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Pain intensity according to the German Pain Questionnaire (DSF) (Pfingsten et al., 2007), visual analogue scales
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3 months
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Pain intensity
Periodo de tiempo: 6 months
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Pain intensity according to the German Pain Questionnaire (DSF) (Pfingsten et al., 2007), visual analogue scales
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6 months
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Pain intensity
Periodo de tiempo: 12 months
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Pain intensity according to the German Pain Questionnaire (DSF) (Pfingsten et al., 2007), visual analogue scales
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12 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Disability
Periodo de tiempo: 3 months
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pain related disability in the domains everyday activity, leisure and work time, visual analogue scales
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3 months
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Disability (PDI)
Periodo de tiempo: 3 months
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Pain Disability Index (Dillmann et al., 1994) validated questionnaire
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3 months
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Quality of life (SF-36)
Periodo de tiempo: 3 months
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Short Form (36) Health Survey (SF-36) [Bullinger & Kirchberger, 1998].
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3 months
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Depression (BDI)
Periodo de tiempo: 3 months
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Beck Depression Inventory (BDI) [Beck, 1987; Hautzinger, 1992]
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3 months
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Life satisfaction (BMLSS)
Periodo de tiempo: 3 months
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Brief Multidimensional Life Satisfaction Scale (BMLSS) [Büssing & Fischer, 2009]
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3 months
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Acceptance (ERDA)
Periodo de tiempo: 3 months
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Emotional/Rational Disease Acceptance Questionnaire [Büssing et al., 2008, 2010]
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3 months
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Self efficacy
Periodo de tiempo: 3 months
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Questionnaire for pain specific self efficacy (FESS) [Mangels et al., 2009)
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3 months
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Coping (AKU)
Periodo de tiempo: 3 months
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Questionnaire for adaptive coping (AKU) [Büssing & Fischer, 2009]
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3 months
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Mindfulness (CPSC)
Periodo de tiempo: 3 months
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modified Freiburger Mindfulness Inventory (Büssing et al.)
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3 months
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Perceived Stress (PSS-10)
Periodo de tiempo: 3 months
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Perceived Stress Scale (PSS-10) [Büssing, 2011)
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3 months
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Inner Congruence (ICPH)
Periodo de tiempo: 3 months
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Inner Congruence with the exercise practise of meditation/relaxation/yoga ... (Büssing et al., 2011)
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3 months
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Practice Diary
Periodo de tiempo: 3 months
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Patients fill in a week long diary.
Measured are the frequency of health behaviors
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3 months
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Experiences with the program
Periodo de tiempo: 3 months
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- satisfaction with the program and perceived benefit
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3 months
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Safety of the program
Periodo de tiempo: 3 months
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- safety
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3 months
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Ability and will to change
Periodo de tiempo: 3 months
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Ability and will to change (Büssing, 2008) - also evaluated at 6 and 12 months |
3 months
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Body awareness (BAQ)
Periodo de tiempo: 3 months
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Translated body awareness questionnaire will be validated. It will further be used for mediation and moderator analysis with the outcomes. - Body Awareness Questionnaire (BAQ) (Shields 1989) |
3 months
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Body awareness (BRS)
Periodo de tiempo: 3 months
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Translated body awareness questionnaire will be validated. It will further be used for mediation and moderator analysis with the outcomes. - Body Responsiveness Scale (BRS)(Daubenmier 2005) |
3 months
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Body awareness (SBC)
Periodo de tiempo: 3 months
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Translated body awareness questionnaire will be validated. It will further be used for mediation and moderator analysis with the outcomes. - Scale of Body Connection (SBC)(Price and Thompson 2007) |
3 months
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Body awareness (PAS)
Periodo de tiempo: 3 months
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Newly developed body awareness questionnaire will be validated. It will further be used for mediation and moderator analysis with the outcomes. - Postural Awareness Scale (PAS) (Cramer et al.) |
3 months
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Body awareness (DKB)
Periodo de tiempo: 3 months
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The DKB will be used for mediation and moderator analysis with the outcomes and for validation purposes. - Dresdner Körperbildfragebogen (DKB)(Pöhlmann et al., 2007) |
3 months
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Director de estudio: Gustav J Dobos, Prof, MD, University of Duisburg-Essen, Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine
- Investigador principal: Romy Lauche, PhD, University of Duisburg-Essen, Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine
- Investigador principal: Holger Cramer, PhD, University of Duisburg-Essen, Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 12-5216 POSITAG
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