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

Phase 3

Completed

• Conditions: Chronic Pain
• Interventions: Other: Wait-listed; Behavioral: Living Everyday Above-and-beyond Pain (LEAP)

• Registration Number: NCT01517256
• Lead Sponsor: McMaster University

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 available

Study Timeline

• Study Start: 2009-11
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Status Verified: 2012-01
• Study First Submitted: 2012-01-16
• Study First Submitted QC: 2012-01-20
• Last Update Submitted: 2012-01-20
• Study First Posted: 2012-01-25
• Last Update Posted: 2012-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• 18 years and older
• diagnosed with chronic pain

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Delayed Intervention Group	Wait-listed	Initially wait-listed and served as control group. But later participants underwent the experimental intervention.
Early Intervention Group	Living Everyday Above-and-beyond Pain (LEAP)	-

Primary Outcome Measures

Name	Time	Method
Quality of Life	8 months	This will utilize the SF-36 QOL questionnaire.
Health care utilization	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

Name	Time	Method
Qualitative process evaluation (Perceptions of participants regarding the intervention)	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	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.

Trial Locations

Locations (1)

McMaster Family Practice Clinic; 🇨🇦 Hamilton, Ontario, Canada