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

Chronic Pain Clinical Trial

— LEAP  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01517256
• Other study ID #: DFM 09-595
• Status: Completed
• Phase: Phase 3
• First received: January 16, 2012
• Last updated: January 20, 2012
• Start date: November 2009
• Est. completion date: November 2011

Study information

• Verified date: January 2012
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: HHS/FHS Research Ethics Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Chronic Pain

Intervention

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.

Locations

Country	Name	City	State
Canada	McMaster Family Practice Clinic	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
McMaster University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of Life	This will utilize the SF-36 QOL questionnaire.	8 months	No
Primary	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	No
Secondary	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	No
Secondary	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	No