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Lifestyle Modification Program for Patients With Chronic Pain Conditions

Process-outcome-study in the Context of a Lifestyle Modification Program for Patients With Chronic Pain Conditions

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01805947
Acronym
POSITAG
Enrollment
200
Registered
2013-03-06
Start date
2013-01-31
Completion date
2015-09-30
Last updated
2015-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Pain

Brief summary

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.

Detailed description

see above

Interventions

BEHAVIORALLifestyle Modification

Lifestyle Modification

Sponsors

University of Witten/Herdecke
CollaboratorOTHER
Universität Duisburg-Essen
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Pain intensity3 monthsPain intensity according to the German Pain Questionnaire (DSF) (Pfingsten et al., 2007), visual analogue scales

Secondary

MeasureTime frameDescription
Quality of life (SF-36)3 monthsShort Form (36) Health Survey (SF-36) \[Bullinger & Kirchberger, 1998\].
Self efficacy3 monthsQuestionnaire for pain specific self efficacy (FESS) \[Mangels et al., 2009)
Coping (AKU)3 monthsQuestionnaire for adaptive coping (AKU) \[Büssing & Fischer, 2009\]
Mindfulness (CPSC)3 monthsmodified Freiburger Mindfulness Inventory (Büssing et al.)
Perceived Stress (PSS-10)3 monthsPerceived Stress Scale (PSS-10) \[Büssing, 2011)
Inner Congruence (ICPH)3 monthsInner Congruence with the exercise practise of meditation/relaxation/yoga ... (Büssing et al., 2011)
Practice Diary3 monthsPatients fill in a week long diary. Measured are the frequency of health behaviors
Experiences with the program3 months\- satisfaction with the program and perceived benefit
Safety of the program3 months\- safety
Disability3 monthspain related disability in the domains everyday activity, leisure and work time, visual analogue scales
Disability (PDI)3 monthsPain Disability Index (Dillmann et al., 1994) validated questionnaire
Depression (BDI)3 monthsBeck Depression Inventory (BDI) \[Beck, 1987; Hautzinger, 1992\]
Life satisfaction (BMLSS)3 monthsBrief Multidimensional Life Satisfaction Scale (BMLSS) \[Büssing & Fischer, 2009\]
Acceptance (ERDA)3 monthsEmotional/Rational Disease Acceptance Questionnaire \[Büssing et al., 2008, 2010\]

Other

MeasureTime frameDescription
Body awareness (BRS)3 monthsTranslated 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)
Body awareness (SBC)3 monthsTranslated 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)
Body awareness (PAS)3 monthsNewly 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.)
Body awareness (DKB)3 monthsThe DKB will be used for mediation and moderator analysis with the outcomes and for validation purposes. \- Dresdner Körperbildfragebogen (DKB)(Pöhlmann et al., 2007)
Ability and will to change3 monthsAbility and will to change (Büssing, 2008) \- also evaluated at 6 and 12 months
Body awareness (BAQ)3 monthsTranslated 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)

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026