Skip to content

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

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01517256
Acronym
LEAP
Enrollment
60
Registered
2012-01-25
Start date
2009-11-30
Completion date
2011-11-30
Last updated
2012-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Pain

Keywords

Chronic pain, Primary care, Multidisciplinary group therapy, Embedded mixed-methods study

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.

Interventions

BEHAVIORALLiving 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.

OTHERWait-listed

Patients are wait-listed while awaiting participation to the LEAP program.

Sponsors

McMaster University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Quality of Life8 monthsThis will utilize the SF-36 QOL questionnaire.
Health care utilization8 monthsThis 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

MeasureTime frameDescription
Qualitative process evaluation (Perceptions of participants regarding the intervention)16 monthsThis 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 use8 monthsThis 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.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026