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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
-
-
-
Essen, Allemagne, 45276
- Department of Internal and Integrative Medicine, Kliniken Essen-Mitte
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
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.
|
Modification du mode de vie
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Pain intensity
Délai: 3 months
|
Pain intensity according to the German Pain Questionnaire (DSF) (Pfingsten et al., 2007), visual analogue scales
|
3 months
|
|
Pain intensity
Délai: 6 months
|
Pain intensity according to the German Pain Questionnaire (DSF) (Pfingsten et al., 2007), visual analogue scales
|
6 months
|
|
Pain intensity
Délai: 12 months
|
Pain intensity according to the German Pain Questionnaire (DSF) (Pfingsten et al., 2007), visual analogue scales
|
12 months
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Disability
Délai: 3 months
|
pain related disability in the domains everyday activity, leisure and work time, visual analogue scales
|
3 months
|
|
Disability (PDI)
Délai: 3 months
|
Pain Disability Index (Dillmann et al., 1994) validated questionnaire
|
3 months
|
|
Quality of life (SF-36)
Délai: 3 months
|
Short Form (36) Health Survey (SF-36) [Bullinger & Kirchberger, 1998].
|
3 months
|
|
Depression (BDI)
Délai: 3 months
|
Beck Depression Inventory (BDI) [Beck, 1987; Hautzinger, 1992]
|
3 months
|
|
Life satisfaction (BMLSS)
Délai: 3 months
|
Brief Multidimensional Life Satisfaction Scale (BMLSS) [Büssing & Fischer, 2009]
|
3 months
|
|
Acceptance (ERDA)
Délai: 3 months
|
Emotional/Rational Disease Acceptance Questionnaire [Büssing et al., 2008, 2010]
|
3 months
|
|
Self efficacy
Délai: 3 months
|
Questionnaire for pain specific self efficacy (FESS) [Mangels et al., 2009)
|
3 months
|
|
Coping (AKU)
Délai: 3 months
|
Questionnaire for adaptive coping (AKU) [Büssing & Fischer, 2009]
|
3 months
|
|
Mindfulness (CPSC)
Délai: 3 months
|
modified Freiburger Mindfulness Inventory (Büssing et al.)
|
3 months
|
|
Perceived Stress (PSS-10)
Délai: 3 months
|
Perceived Stress Scale (PSS-10) [Büssing, 2011)
|
3 months
|
|
Inner Congruence (ICPH)
Délai: 3 months
|
Inner Congruence with the exercise practise of meditation/relaxation/yoga ... (Büssing et al., 2011)
|
3 months
|
|
Practice Diary
Délai: 3 months
|
Patients fill in a week long diary.
Measured are the frequency of health behaviors
|
3 months
|
|
Experiences with the program
Délai: 3 months
|
- satisfaction with the program and perceived benefit
|
3 months
|
|
Safety of the program
Délai: 3 months
|
- safety
|
3 months
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Ability and will to change
Délai: 3 months
|
Ability and will to change (Büssing, 2008) - also evaluated at 6 and 12 months |
3 months
|
|
Body awareness (BAQ)
Délai: 3 months
|
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
|
|
Body awareness (BRS)
Délai: 3 months
|
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
|
|
Body awareness (SBC)
Délai: 3 months
|
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
|
|
Body awareness (PAS)
Délai: 3 months
|
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
|
|
Body awareness (DKB)
Délai: 3 months
|
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
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Directeur d'études: Gustav J Dobos, Prof, MD, University of Duisburg-Essen, Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine
- Chercheur principal: Romy Lauche, PhD, University of Duisburg-Essen, Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine
- Chercheur principal: Holger Cramer, PhD, University of Duisburg-Essen, Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 12-5216 POSITAG
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .