NCT01805947

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 5, 2013

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 6, 2013

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

September 4, 2015

Status Verified

September 1, 2015

Enrollment Period

2.2 years

First QC Date

March 5, 2013

Last Update Submit

September 3, 2015

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (14)

  • Disability

    3 months

  • Disability (PDI)

    3 months

  • Quality of life (SF-36)

    3 months

  • Depression (BDI)

    3 months

  • Life satisfaction (BMLSS)

    3 months

  • +9 more secondary outcomes

Other Outcomes (6)

  • Ability and will to change

    3 months

  • Body awareness (BAQ)

    3 months

  • Body awareness (BRS)

    3 months

  • +3 more other outcomes

Study Arms (1)

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.

Behavioral: Lifestyle Modification

Interventions

Lifestyle ModificationBEHAVIORAL

Lifestyle Modification

Also known as: see Paul, A. et al.,Eur J Integr Med 2012, 4(4):e455-e459.
Lifestyle Modification

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

200 patients with pain condition admitted to the lifestyle modification program

You may qualify if:

  • diagnosed with any chronic pain condition
  • physical and mental ability to participate in the program and the study
  • written informed consent

You may not qualify if:

  • participation in any other clinical study focusing on psychological or behavioral intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Internal and Integrative Medicine, Kliniken Essen-Mitte

Essen, 45276, Germany

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Gustav J Dobos, Prof, MD

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

    STUDY DIRECTOR

  • Romy Lauche, PhD

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

    PRINCIPAL INVESTIGATOR

  • Holger Cramer, PhD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 5, 2013

First Posted

March 6, 2013

Study Start

January 1, 2013

Primary Completion

April 1, 2015

Study Completion

September 1, 2015

Last Updated

September 4, 2015

Record last verified: 2015-09

Locations

DE(1)