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

History of Changes

Tracking Information
First Received Date ^ICMJE	January 16, 2012
Last Updated Date	January 20, 2012
Start Date ^ICMJE	November 2009
Primary Completion Date	November 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: January 20, 2012)	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).
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01517256 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: January 20, 2012)	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.
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Pilot Study Evaluating a Multidisciplinary Chronic Pain Group Therapy in a Primary Care Setting
Official Title ^ICMJE	Living Everyday Above-and-beyond Pain Research (LEAP): A Pilot Study Evaluating a Multidisciplinary Chronic Pain Group Therapy in a Primary Care Setting
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care
Condition ^ICMJE	Chronic Pain
Intervention ^ICMJE	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.
Study Arm (s)	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
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	60
Completion Date	November 2011
Primary Completion Date	November 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Canada

Administrative Information
NCT Number ^ICMJE	NCT01517256
Other Study ID Numbers ^ICMJE	DFM 09-595
Has Data Monitoring Committee	Not Provided
Responsible Party	McMaster University
Study Sponsor ^ICMJE	McMaster University
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	McMaster University
Verification Date	January 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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