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Completed

NCT Number: NCT01517256

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

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.

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Key information

Conditions

Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

McMaster Family Practice Clinic

Hamilton, Ontario, L8S 1A4, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Living Everyday Above-and-beyond Pain (LEAP)

Behavioral

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.

Wait-listed

Other

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

Primary outcomes

  1. Quality of Life

    Time frame: 8 months

    This will utilize the SF-36 QOL questionnaire.

  2. 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 outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Registry information

Official study title

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

Acronym: LEAP

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jan 25, 2012
Registry last updated
Jan 25, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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