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.
Studieoversikt
Detaljert beskrivelse
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
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Essen, Tyskland, 45276
- Department of Internal and Integrative Medicine, Kliniken Essen-Mitte
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
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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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Livsstilsendring
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Pain intensity
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Disability
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 3 months
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- safety
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3 months
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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Ability and will to change
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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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Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Studieleder: Gustav J Dobos, Prof, MD, University of Duisburg-Essen, Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine
- Hovedetterforsker: Romy Lauche, PhD, University of Duisburg-Essen, Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine
- Hovedetterforsker: Holger Cramer, PhD, University of Duisburg-Essen, Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 12-5216 POSITAG
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