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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
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Essen, Alemanha, 45276
- Department of Internal and Integrative Medicine, Kliniken Essen-Mitte
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
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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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Modificação do estilo de vida
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Pain intensity
Prazo: 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
Prazo: 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
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Disability
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 3 months
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- safety
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3 months
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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Ability and will to change
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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
- Diretor de estudo: 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
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 (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 12-5216 POSITAG
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