NCT01517256

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at below P25 for phase_3 chronic-pain

Timeline
Completed

Started Nov 2009

Typical duration for phase_3 chronic-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 16, 2012

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 25, 2012

Completed
Last Updated

January 25, 2012

Status Verified

January 1, 2012

Enrollment Period

2 years

First QC Date

January 16, 2012

Last Update Submit

January 20, 2012

Conditions

Chronic Pain

Keywords

Chronic painPrimary careMultidisciplinary group therapyEmbedded mixed-methods study

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • Qualitative process evaluation (Perceptions of participants regarding the intervention)

    16 months

  • Pain medication use

    8 months

Study Arms (2)

Early Intervention Group

EXPERIMENTAL
Behavioral: Living Everyday Above-and-beyond Pain (LEAP)

Delayed Intervention Group

PLACEBO COMPARATOR

Initially wait-listed and served as control group. But later participants underwent the experimental intervention.

Other: Wait-listed

Interventions

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.

Early Intervention Group
Wait-listedOTHER

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

Delayed Intervention Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years and older
  • diagnosed with chronic pain

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McMaster Family Practice Clinic

Hamilton, Ontario, L8S 1A4, Canada

Location

Related Publications (1)

  • Angeles RN, Guenter D, McCarthy L, Bauer M, Wolfson M, Chacon M, Bullock L. Group interprofessional chronic pain management in the primary care setting: a pilot study of feasibility and effectiveness in a family health team in Ontario. Pain Res Manag. 2013 Sep-Oct;18(5):237-42. doi: 10.1155/2013/491279. Epub 2013 Jul 19.

    PMID: 23875181DERIVED

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2012

First Posted

January 25, 2012

Study Start

November 1, 2009

Primary Completion

November 1, 2011

Study Completion

November 1, 2011

Last Updated

January 25, 2012

Record last verified: 2012-01

Locations

CA(1)