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

Study Overview
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Brief Summary
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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.

Official Title
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Living Everyday Above-and-beyond Pain Research (LEAP): A Pilot Study Evaluating a Multidisciplinary Chronic Pain Group Therapy in a Primary Care Setting

Conditions
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Chronic Pain

Intervention / Treatment
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* Behavioral: Living Everyday Above-and-beyond Pain (LEAP)
* Other: Wait-listed


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early Intervention Group<br> | Behavioral: Living Everyday Above-and-beyond Pain (LEAP)<br>* 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.<br>|
| Placebo Comparator: Delayed Intervention Group<br>Initially wait-listed and served as control group. But later participants underwent the experimental intervention. | Other: Wait-listed<br>* Patients are wait-listed while awaiting participation to the LEAP program.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life | This will utilize the SF-36 QOL questionnaire. | 8 months | 
| Health care utilization | 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). | 8 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Qualitative process evaluation (Perceptions of participants regarding the intervention) | 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. | 16 months | 
| Pain medication use | 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. | 8 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic pain, Primary care, Multidisciplinary group therapy, Embedded mixed-methods study