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| Name | Class |
|---|---|
| University of Witten/Herdecke | OTHER |
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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.
see above
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lifestyle Modification | Behavioral | Lifestyle Modification |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain intensity | Pain intensity according to the German Pain Questionnaire (DSF) (Pfingsten et al., 2007), visual analogue scales | 3 months |
| Pain intensity | Pain intensity according to the German Pain Questionnaire (DSF) (Pfingsten et al., 2007), visual analogue scales | 6 months |
| Pain intensity | Pain intensity according to the German Pain Questionnaire (DSF) (Pfingsten et al., 2007), visual analogue scales | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Disability | pain related disability in the domains everyday activity, leisure and work time, visual analogue scales | 3 months |
| Disability (PDI) | Pain Disability Index (Dillmann et al., 1994) validated questionnaire |
| Measure | Description | Time Frame |
|---|---|---|
| Ability and will to change | Ability and will to change (Büssing, 2008) - also evaluated at 6 and 12 months | 3 months |
| Body awareness (BAQ) | 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) |
Inclusion Criteria:
Exclusion Criteria:
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200 patients with pain condition admitted to the lifestyle modification program
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| Name | Affiliation | Role |
|---|---|---|
| Gustav J Dobos, Prof, MD | University of Duisburg-Essen, Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine | Study Director |
| Romy Lauche, PhD | University of Duisburg-Essen, Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine | Principal Investigator |
| Holger Cramer, PhD | University of Duisburg-Essen, Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Internal and Integrative Medicine, Kliniken Essen-Mitte | Essen | 45276 | Germany |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 3 months |
| Quality of life (SF-36) | Short Form (36) Health Survey (SF-36) [Bullinger & Kirchberger, 1998]. | 3 months |
| Depression (BDI) | Beck Depression Inventory (BDI) [Beck, 1987; Hautzinger, 1992] | 3 months |
| Life satisfaction (BMLSS) | Brief Multidimensional Life Satisfaction Scale (BMLSS) [Büssing & Fischer, 2009] | 3 months |
| Acceptance (ERDA) | Emotional/Rational Disease Acceptance Questionnaire [Büssing et al., 2008, 2010] | 3 months |
| Self efficacy | Questionnaire for pain specific self efficacy (FESS) [Mangels et al., 2009)](streamdown:incomplete-link) | 3 months |
| Coping (AKU) | Questionnaire for adaptive coping (AKU) [Büssing & Fischer, 2009] | 3 months |
| Mindfulness (CPSC) | modified Freiburger Mindfulness Inventory (Büssing et al.) | 3 months |
| Perceived Stress (PSS-10) | Perceived Stress Scale (PSS-10) [Büssing, 2011)](streamdown:incomplete-link) | 3 months |
| Inner Congruence (ICPH) | Inner Congruence with the exercise practise of meditation/relaxation/yoga ... (Büssing et al., 2011) | 3 months |
| Practice Diary | Patients fill in a week long diary. Measured are the frequency of health behaviors | 3 months |
| Experiences with the program | - satisfaction with the program and perceived benefit | 3 months |
| Safety of the program | - safety | 3 months |
| 3 months |
| Body awareness (BRS) | 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) | 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) | 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) | 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 |