Lifestyle Modification Program for Patients With Chronic Pain Conditions

Completed

• Conditions: Chronic Pain
• Interventions: Behavioral: Lifestyle Modification

• Registration Number: NCT01805947
• Lead Sponsor: Universität Duisburg-Essen

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

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-03-05
• Study First Submitted QC: 2013-03-05
• Study First Posted: 2013-03-06
• Primary Completion: 2015-04
• Status Verified: 2015-09
• Study Completion: 2015-09
• Last Update Submitted: 2015-09-03
• Last Update Posted: 2015-09-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Lifestyle Modification	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.

Primary Outcome Measures

Name	Time	Method
Pain intensity	12 months	Pain intensity according to the German Pain Questionnaire (DSF) (Pfingsten et al., 2007), visual analogue scales

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Internal and Integrative Medicine, Kliniken Essen-Mitte; 🇩🇪 Essen, Germany