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A Pilot Study Evaluating a Multidisciplinary Chronic Pain Group Therapy in a Primary Care Setting (LEAP)
This study has been completed.
Sponsor:
McMaster University
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
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Purpose
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 | Intervention | Phase |
|---|---|---|
| Chronic Pain | Behavioral: Living Everyday Above-and-beyond Pain (LEAP) Other: Wait-listed | Phase 3 |
| Study Type: | Interventional |
| Study Design: | 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 |
Resource links provided by NLM:
Further study details as provided by McMaster University:
Primary Outcome Measures:
- Quality of Life [ Time Frame: 8 months ]This will utilize the SF-36 QOL questionnaire.
- 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:
- 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.
- 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.
| Enrollment: | 60 |
| Study Start Date: | November 2009 |
| Study Completion Date: | November 2011 |
| Primary Completion Date: | November 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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.
|
Eligibility| 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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For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01517256
Please refer to this study by its ClinicalTrials.gov identifier: NCT01517256
Locations
| Canada, Ontario | |
| McMaster Family Practice Clinic | |
| Hamilton, Ontario, Canada, L8S 1A4 | |
Sponsors and Collaborators
McMaster University
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 |
| Study First Received: | January 16, 2012 |
| Last Updated: | January 20, 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 |
ClinicalTrials.gov processed this record on August 22, 2017