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.

Study Overview

• Status: Completed
• Conditions: Chronic Pain
• Intervention / Treatment: Behavioral: Lifestyle Modification

Detailed Description

see above

• Study Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• Germany
  • Essen, Germany, 45276
    • Department of Internal and Integrative Medicine, Kliniken Essen-Mitte

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

200 patients with pain condition admitted to the lifestyle modification program

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Behavioral: Lifestyle Modification; Lifestyle Modification; Other Names: see Paul, A. et al.,Eur J Integr Med 2012, 4(4):e455-e459.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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)	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)	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

Other Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: Universität Duisburg-Essen
• Collaborators: University of Witten/Herdecke
• Investigators: Study Director: Gustav J Dobos, Prof, MD, University of Duisburg-Essen, Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine; Principal Investigator: 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

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: March 5, 2013
• First Submitted That Met QC Criteria: March 5, 2013
• First Posted (Estimate): March 6, 2013

Study Record Updates

• Last Update Posted (Estimate): September 4, 2015
• Last Update Submitted That Met QC Criteria: September 3, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: 12-5216 POSITAG