Lifestyle Modification Program for Patients With Chronic Pain Conditions

Chronic Pain Clinical Trial

— POSITAG  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01805947
• Other study ID #: 12-5216 POSITAG
• Status: Completed
• Phase: N/A
• First received: March 5, 2013
• Last updated: September 3, 2015
• Start date: January 2013
• Est. completion date: September 2015

Study information

• Verified date: September 2015
• Source: Universität Duisburg-Essen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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.

Description:

see above

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: September 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Behavioral:
• Lifestyle Modification
Lifestyle Modification

Locations

Country	Name	City	State
Germany	Department of Internal and Integrative Medicine, Kliniken Essen-Mitte	Essen

Sponsors (2)

Lead Sponsor	Collaborator
Universität Duisburg-Essen	University of Witten/Herdecke

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Ability and will to change	Ability and will to change (Büssing, 2008); - also evaluated at 6 and 12 months	3 months	No
Other	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	No
Other	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	No
Other	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	No
Other	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	No
Other	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	No
Primary	Pain intensity	Pain intensity according to the German Pain Questionnaire (DSF) (Pfingsten et al., 2007), visual analogue scales	3 months	No
Primary	Pain intensity	Pain intensity according to the German Pain Questionnaire (DSF) (Pfingsten et al., 2007), visual analogue scales	6 months	No
Primary	Pain intensity	Pain intensity according to the German Pain Questionnaire (DSF) (Pfingsten et al., 2007), visual analogue scales	12 months	No
Secondary	Disability	pain related disability in the domains everyday activity, leisure and work time, visual analogue scales	3 months	No
Secondary	Disability (PDI)	Pain Disability Index (Dillmann et al., 1994) validated questionnaire	3 months	No
Secondary	Quality of life (SF-36)	Short Form (36) Health Survey (SF-36) [Bullinger & Kirchberger, 1998].	3 months	No
Secondary	Depression (BDI)	Beck Depression Inventory (BDI) [Beck, 1987; Hautzinger, 1992]	3 months	No
Secondary	Life satisfaction (BMLSS)	Brief Multidimensional Life Satisfaction Scale (BMLSS) [Büssing & Fischer, 2009]	3 months	No
Secondary	Acceptance (ERDA)	Emotional/Rational Disease Acceptance Questionnaire [Büssing et al., 2008, 2010]	3 months	No
Secondary	Self efficacy	Questionnaire for pain specific self efficacy (FESS) [Mangels et al., 2009)	3 months	No
Secondary	Coping (AKU)	Questionnaire for adaptive coping (AKU) [Büssing & Fischer, 2009]	3 months	No
Secondary	Mindfulness (CPSC)	modified Freiburger Mindfulness Inventory (Büssing et al.)	3 months	No
Secondary	Perceived Stress (PSS-10)	Perceived Stress Scale (PSS-10) [Büssing, 2011)	3 months	No
Secondary	Inner Congruence (ICPH)	Inner Congruence with the exercise practise of meditation/relaxation/yoga ... (Büssing et al., 2011)	3 months	No
Secondary	Practice Diary	Patients fill in a week long diary. Measured are the frequency of health behaviors	3 months	No
Secondary	Experiences with the program	- satisfaction with the program and perceived benefit	3 months	No
Secondary	Safety of the program	- safety	3 months	Yes