Process-outcome-study in the Context of a Lifestyle Modification Program for Patients With Chronic Pain Conditions
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic Pain
- Sponsor
- Universität Duisburg-Essen
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Pain intensity
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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
Investigators
Romy Lauche
Principal Investigator
Universität Duisburg-Essen
Eligibility Criteria
Inclusion Criteria
- •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
Outcomes
Primary Outcomes
Pain intensity
Time Frame: 12 months
Pain intensity according to the German Pain Questionnaire (DSF) (Pfingsten et al., 2007), visual analogue scales
Secondary Outcomes
- Practice Diary(3 months)
- Disability(3 months)
- Acceptance (ERDA)(3 months)
- Perceived Stress (PSS-10)(3 months)
- Inner Congruence (ICPH)(3 months)
- Safety of the program(3 months)
- Disability (PDI)(3 months)
- Mindfulness (CPSC)(3 months)
- Experiences with the program(3 months)
- Quality of life (SF-36)(3 months)
- Depression (BDI)(3 months)
- Life satisfaction (BMLSS)(3 months)
- Self efficacy(3 months)
- Coping (AKU)(3 months)