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.
Studieöversikt
Detaljerad beskrivning
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
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Essen, Tyskland, 45276
- Department of Internal and Integrative Medicine, Kliniken Essen-Mitte
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / 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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Livsstilsändring
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Pain intensity
Tidsram: 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
Tidsram: 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
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Disability
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 3 months
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- safety
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3 months
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Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Ability and will to change
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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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Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Studierektor: Gustav J Dobos, Prof, MD, University of Duisburg-Essen, Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine
- Huvudutredare: Romy Lauche, PhD, University of Duisburg-Essen, Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine
- Huvudutredare: Holger Cramer, PhD, University of Duisburg-Essen, Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 12-5216 POSITAG
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