Lifestyle Modification Program for Patients With Chronic Pain Conditions

NCT ID: NCT01805947

Last Updated: 2015-09-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-01-31

Study Completion Date

2015-09-30

Brief Summary

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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

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see above

Conditions

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Chronic Pain

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Lifestyle Modification

Intervention Type BEHAVIORAL

Lifestyle Modification

Interventions

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Lifestyle Modification

Lifestyle Modification

Intervention Type BEHAVIORAL

Other Intervention Names

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

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Witten/Herdecke

OTHER

Sponsor Role collaborator

Universität Duisburg-Essen

OTHER

Sponsor Role lead

Responsible Party

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Romy Lauche

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gustav J Dobos, Prof, MD

Role: STUDY_DIRECTOR

University of Duisburg-Essen, Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine

Romy Lauche, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Duisburg-Essen, Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine

Holger Cramer, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Duisburg-Essen, Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine

Locations

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Department of Internal and Integrative Medicine, Kliniken Essen-Mitte

Essen, , Germany

Site Status

Countries

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Germany

Other Identifiers

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12-5216 POSITAG

Identifier Type: -

Identifier Source: org_study_id

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