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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
McMaster University
ClinicalTrials.gov Identifier:
NCT01517256
First received: January 16, 2012
Last updated: January 20, 2012
Last verified: January 2012

January 16, 2012
January 20, 2012
November 2009
November 2011   (final data collection date for primary outcome measure)
  • Quality of Life [ Time Frame: 8 months ] [ Designated as safety issue: No ]
    This will utilize the SF-36 QOL questionnaire.
  • Health care utilization [ Time Frame: 8 months ] [ Designated as safety issue: No ]
    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).
Same as current
Complete list of historical versions of study NCT01517256 on ClinicalTrials.gov Archive Site
  • Qualitative process evaluation (Perceptions of participants regarding the intervention) [ Time Frame: 16 months ] [ Designated as safety issue: No ]
    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.
  • Pain medication use [ Time Frame: 8 months ] [ Designated as safety issue: No ]
    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.
Same as current
Not Provided
Not Provided
 
A Pilot Study Evaluating a Multidisciplinary Chronic Pain Group Therapy in a Primary Care Setting
Living Everyday Above-and-beyond Pain Research (LEAP): A Pilot Study Evaluating a Multidisciplinary Chronic Pain Group Therapy in a Primary Care Setting

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Chronic Pain
  • 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.
  • Other: Wait-listed
    Patients are wait-listed while awaiting participation to the LEAP program.
  • Experimental: Early Intervention Group
    Intervention: Behavioral: Living Everyday Above-and-beyond Pain (LEAP)
  • Placebo Comparator: Delayed Intervention Group
    Initially wait-listed and served as control group. But later participants underwent the experimental intervention.
    Intervention: Other: Wait-listed
Angeles RN, Guenter D, McCarthy L, Bauer M, Wolfson M, Chacon M, Bullock L. Group interprofessional chronic pain management in the primary care setting: a pilot study of feasibility and effectiveness in a family health team in Ontario. Pain Res Manag. 2013 Sep-Oct;18(5):237-42. Epub 2013 Jul 19.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
November 2011
November 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01517256
DFM 09-595
Not Provided
McMaster University
McMaster University
Not Provided
Not Provided
McMaster University
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP