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NCT Number: NCT01805947

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.

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Key information

Conditions

Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Internal and Integrative Medicine, Kliniken Essen-Mitte

Essen, 45276, Germany

About this study

see above

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lifestyle Modification

Behavioral

Lifestyle Modification

Other names: see Paul, A. et al.,Eur J Integr Med 2012, 4(4):e455-e459.

Primary outcomes

  1. Pain intensity

    Time frame: 3 months

    Pain intensity according to the German Pain Questionnaire (DSF) (Pfingsten et al., 2007), visual analogue scales

  2. Pain intensity

    Time frame: 6 months

    Pain intensity according to the German Pain Questionnaire (DSF) (Pfingsten et al., 2007), visual analogue scales

  3. Pain intensity

    Time frame: 12 months

    Pain intensity according to the German Pain Questionnaire (DSF) (Pfingsten et al., 2007), visual analogue scales

Secondary outcomes

  1. Disability

    Time frame: 3 months

    pain related disability in the domains everyday activity, leisure and work time, visual analogue scales

  2. Disability (PDI)

    Time frame: 3 months

    Pain Disability Index (Dillmann et al., 1994) validated questionnaire

  3. Quality of life (SF-36)

    Time frame: 3 months

    Short Form (36) Health Survey (SF-36) [Bullinger & Kirchberger, 1998].

  4. Depression (BDI)

    Time frame: 3 months

    Beck Depression Inventory (BDI) [Beck, 1987; Hautzinger, 1992]

  5. Life satisfaction (BMLSS)

    Time frame: 3 months

    Brief Multidimensional Life Satisfaction Scale (BMLSS) [Büssing & Fischer, 2009]

  6. Acceptance (ERDA)

    Time frame: 3 months

    Emotional/Rational Disease Acceptance Questionnaire [Büssing et al., 2008, 2010]

  7. Self efficacy

    Time frame: 3 months

    Questionnaire for pain specific self efficacy (FESS) [Mangels et al., 2009)

  8. Coping (AKU)

    Time frame: 3 months

    Questionnaire for adaptive coping (AKU) [Büssing & Fischer, 2009]

  9. Mindfulness (CPSC)

    Time frame: 3 months

    modified Freiburger Mindfulness Inventory (Büssing et al.)

  10. Perceived Stress (PSS-10)

    Time frame: 3 months

    Perceived Stress Scale (PSS-10) [Büssing, 2011)

  11. Inner Congruence (ICPH)

    Time frame: 3 months

    Inner Congruence with the exercise practise of meditation/relaxation/yoga ... (Büssing et al., 2011)

  12. Practice Diary

    Time frame: 3 months

    Patients fill in a week long diary. Measured are the frequency of health behaviors

  13. Experiences with the program

    Time frame: 3 months

    • satisfaction with the program and perceived benefit

  14. Safety of the program

    Time frame: 3 months

    • safety

Other outcomes

  1. Ability and will to change

    Time frame: 3 months

    Ability and will to change (Büssing, 2008)

    • also evaluated at 6 and 12 months

  2. Body awareness (BAQ)

    Time frame: 3 months

    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. Body awareness (BRS)

    Time frame: 3 months

    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)

  4. Body awareness (SBC)

    Time frame: 3 months

    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)

  5. Body awareness (PAS)

    Time frame: 3 months

    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.)

  6. Body awareness (DKB)

    Time frame: 3 months

    The DKB will be used for mediation and moderator analysis with the outcomes and for validation purposes.

    • Dresdner Körperbildfragebogen (DKB)(Pöhlmann et al., 2007)

Sponsors and collaborators

Lead sponsor

Universität Duisburg-Essen

Other

Collaborators

  • University of Witten/Herdecke

Registry information

Official study title

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

Acronym: POSITAG

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Mar 6, 2013
Registry last updated
Sep 4, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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