Lifestyle Modification Program for Patients With Chronic Pain Conditions

Study 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

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

Conditions
-----------------
Chronic Pain

Intervention / Treatment
-----------------
* Behavioral: Lifestyle Modification


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Lifestyle Modification<br>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<br>* Lifestyle Modification<br>* 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 |