A Pilot Study Evaluating a Multidisciplinary Chronic Pain Group Therapy in a Primary Care Setting (LEAP)
|ClinicalTrials.gov Identifier: NCT01517256|
Recruitment Status : Completed
First Posted : January 25, 2012
Last Update Posted : January 25, 2012
|Condition or disease||Intervention/treatment||Phase|
|Chronic Pain||Behavioral: Living Everyday Above-and-beyond Pain (LEAP) Other: Wait-listed||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|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|
|Study Start Date :||November 2009|
|Actual Primary Completion Date :||November 2011|
|Actual Study Completion Date :||November 2011|
|Experimental: Early Intervention Group||
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.
Placebo Comparator: Delayed Intervention Group
Initially wait-listed and served as control group. But later participants underwent the experimental intervention.
Patients are wait-listed while awaiting participation to the LEAP program.
- Quality of Life [ Time Frame: 8 months ]This will utilize the SF-36 QOL questionnaire.
- 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).
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01517256
|McMaster Family Practice Clinic|
|Hamilton, Ontario, Canada, L8S 1A4|