Clinical trial NCT01805947: Lifestyle Modification Program for Patients With Chronic Pain Conditions
Official title: Process-outcome-study in the Context of a Lifestyle Modification Program for Patients With Chronic Pain Conditions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Pain
Lead sponsor: Universität Duisburg-Essen
Sponsor class: OTHER
Collaborators: name: University of Witten/Herdecke
First posted: 2013-03-06
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 200 patients with pain condition admitted to the lifestyle modification program

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

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

Primary outcomes:
measure: Pain intensity
timeFrame: 3 months
measure: Pain intensity
timeFrame: 6 months
measure: Pain intensity
timeFrame: 12 months
Secondary outcomes:
measure: Disability
timeFrame: 3 months
measure: Disability (PDI)
timeFrame: 3 months
measure: Quality of life (SF-36)
timeFrame: 3 months
measure: Depression (BDI)
timeFrame: 3 months
measure: Life satisfaction (BMLSS)
timeFrame: 3 months
measure: Acceptance (ERDA)
timeFrame: 3 months
measure: Self efficacy
timeFrame: 3 months
measure: Coping (AKU)
timeFrame: 3 months
measure: Mindfulness (CPSC)
timeFrame: 3 months
measure: Perceived Stress (PSS-10)
timeFrame: 3 months
measure: Inner Congruence (ICPH)
timeFrame: 3 months
measure: Practice Diary
timeFrame: 3 months
measure: Experiences with the program
timeFrame: 3 months
measure: Safety of the program
timeFrame: 3 months
Other outcomes:
measure: Ability and will to change
timeFrame: 3 months
measure: Body awareness (BAQ)
timeFrame: 3 months
measure: Body awareness (BRS)
timeFrame: 3 months
measure: Body awareness (SBC)
timeFrame: 3 months
measure: Body awareness (PAS)
timeFrame: 3 months
measure: Body awareness (DKB)
timeFrame: 3 months
Locations:
city: Essen
country: Germany
facility: Department of Internal and Integrative Medicine, Kliniken Essen-Mitte
Study officials:
affiliation: University of Duisburg-Essen, Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine
name: Gustav J Dobos, Prof, MD
role: STUDY_DIRECTOR
affiliation: University of Duisburg-Essen, Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine
name: Romy Lauche, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Duisburg-Essen, Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine
name: Holger Cramer, PhD
role: PRINCIPAL_INVESTIGATOR
References: