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A Pilot Study Evaluating a Multidisciplinary Chronic Pain Group Therapy in a Primary Care Setting (LEAP)

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ClinicalTrials.gov Identifier: NCT01517256
Recruitment Status : Completed
First Posted : January 25, 2012
Last Update Posted : January 25, 2012
Sponsor:
Information provided by (Responsible Party):
McMaster University

Study Description
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Brief Summary:
The investigators will evaluate the effectiveness of "Living Everyday Above-and-beyond Pain" (LEAP) program in the primary care setting. LEAP is a multidisciplinary chronic pain group therapy developed for the two clinic sites of McMaster Family Health Team: McMaster Family Practice and Stonechurch Family Health Centre. LEAP aims to improve patients'quality of life, interaction with the health care system and their health care utilization. This is a pilot study to evaluate mainly feasibility. The investigators will make use of both experimental and qualitative methods gather evidence of the programs success, strengths and weaknesses.

Condition or disease Intervention/treatment Phase
Chronic Pain Behavioral: Living Everyday Above-and-beyond Pain (LEAP) Other: Wait-listed Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Living Everyday Above-and-beyond Pain Research (LEAP): A Pilot Study Evaluating a Multidisciplinary Chronic Pain Group Therapy in a Primary Care Setting
Study Start Date : November 2009
Actual Primary Completion Date : November 2011
Actual Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain
U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Early Intervention Group Behavioral: Living Everyday Above-and-beyond Pain (LEAP)
8-week multidisciplinary group therapy aiming consisting of education about the nature of chronic pain, pacing and goal setting, mindfulness medication techniques, cognitive reflections on beliefs, impulses and obsessions, physical activation, and medication management.
Placebo Comparator: Delayed Intervention Group
Initially wait-listed and served as control group. But later participants underwent the experimental intervention.
 Other: Wait-listed
Patients are wait-listed while awaiting participation to the LEAP program.


Outcome Measures
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Primary Outcome Measures :
  1. Quality of Life [ Time Frame: 8 months ]
    This will utilize the SF-36 QOL questionnaire.

  2. Health care utilization [ Time Frame: 8 months ]
    This will be based on a chart review to assess the number of consultations with their family physician and other clinicians (Nurse practitioners, registered nurse, dietitian, social worker).


Secondary Outcome Measures :
  1. Qualitative process evaluation (Perceptions of participants regarding the intervention) [ Time Frame: 16 months ]
    This outcome assesses the views of the participants regarding the strengths and weaknesses of the intervention. It will assess ways to improve the recruitment process and retention of participants in the group, satisfaction of the participants regarding the processes (group dynamics, time, format, contents, etc), perceptions of participants regarding the effectiveness of the program, and suggestion of participants regarding ways to improve the program.

  2. Pain medication use [ Time Frame: 8 months ]
    This will be based on a standardized questionnaire developed by the researchers and a chart review regarding request for early refill and increased dose of medications due to worsening of chronic pain.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years and older
  • diagnosed with chronic pain

Exclusion Criteria:

  • chronic pain related to cancer, pelvic pain or headache
  • inability to speak or write in English
  • patient is unable to attend and participate in group treatment sessions on their own
  • substance use or mental health problems of a severity making group treatment participation impossible
  • currently participating in another cognitive-behavioral pain management program
  • patient is receiving palliative care or has been diagnosed with an illness expecting to cause death within one year
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01517256


Locations
Canada, Ontario
McMaster Family Practice Clinic
Hamilton, Ontario, Canada, L8S 1A4
Sponsors and Collaborators
McMaster University
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: McMaster University
ClinicalTrials.gov Identifier: NCT01517256     History of Changes
Other Study ID Numbers: DFM 09-595
First Posted: January 25, 2012    Key Record Dates
Last Update Posted: January 25, 2012
Last Verified: January 2012

Keywords provided by McMaster University:
Chronic pain
Primary care
Multidisciplinary group therapy
Embedded mixed-methods study

Additional relevant MeSH terms:
Chronic Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms