Back to resultsOnline Mindfulness-based Stress Reduction Intervention for People With Chronic Pain Waiting for Health Services
Primary Purpose
Chronic Pain
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Mindfulness-based stress reduction
Sponsored by
About this trial
This is an interventional supportive care trial for Chronic Pain focused on measuring mindfulness-based stress reduction intervention
Eligibility Criteria
Inclusion Criteria:
- Men and women aged 18-85
- Self-reported diagnosis of chronic non-cancer pain
- Chronic non-cancer pain duration of 3 months or more
- Chronic non-cancer pain experienced during 4 days or more per week
- Average pain intensity of 4 or more out of 10 in the last seven days
- French or English fluency
- Access to Wi-Fi
- Be able to attend a weekly two-hour MBSR virtual session for eight consecutive weeks
Exclusion Criteria:
- Cancer-related chronic pain
- Currently receiving or have received in the last 24 months coordinated care in pain clinics, hospitals or rehabilitation centers.
- Current or recent participation (in the last 12 months and more than 12 sessions) of cognitive-behavioral therapy or MBSR program
- Having an unstable psychological conditions such as depression, bipolar disorder, post-traumatic stress disorder, psychotic disorder
Sites / Locations
- Association québécoise de la douleur chronique
- Centre de réadaptation Layton-Lethbridge-Mackay
- Hôpital de Verdun
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Mindfulness-based stress reduction intervention
Waiting list
Arm Description
Online 8-week group program, once per week
Controls will not receive any intervention during this time. They are on chronic pain clinics waiting list
Outcomes
Primary Outcome Measures
Participants retention rate
The percentage of participants who have completed the 8 online MBSR sessions
Participants participation rate
The percentage of participants on waiting lists who agreed to participate in the intervention
Secondary Outcome Measures
Patient-Reported Outcomes Measurement Information System Global-10
Change in domains of health and functioning as measured by the PROMIS Global-10, score range is 7-35 with increases in scores meaning better outcome
Patient-Reported Outcomes Measurement Information System 29
Change in 8 health-related quality of life domains as measured by the PROMIS 29. PROMIS-29 is a generic patient reported outcome measure, which includes four items from each of the seven PROMIS domains (physical function, depression, anxiety, fatigue, sleep disturbance, and ability to participate in social roles and activities, pain interference) and a single item on pain intensity. Each item has five response options (values 1 to 5), except for the pain intensity item which has eleven response options (values 0 to 10). A total raw score is computed for each domain as the sum of the response to each question within the domain, leading to seven domain scores, each from 4 to 20.
French-Canadian Chronic Pain Self-Efficacy Scale
The French-Canadian Chronic Pain Self-Efficacy Scale (Lacasse et al., 2015) is a 6-item scale that measures an individual's confidence in his/her ability to manage chronic pain in general and pain-related symptoms. Items are rated on a 10-point Likert scale ranging from 1 = not at all confident to 10 = entirely confident. Score range is 6-60 with higher scores reflecting greater chronic pain self-efficacy.
Chronic Pain Acceptance Questionnaire
The Chronic Pain Acceptance Questionnaire (CPAQ-8; Fish et al., 2010 ) is an 8-item scale comprised of two subscales: activity engagement and pain willingness. Items are scored on a 7-point Likert scale ranging from 0 = never true to 6 = always true. Score range is 0-48 with increases in scores meaning better outcome.
Global Rating of Change Scale
The Global Change Rating Scale (11-point visual analogue scale raging from minus 5 to plus 5) will be used to assess the participants' perception of improvement (or decline) in relation to their self-efficacy in manging pain at the end of the MBSR intervention.
Pain Catastrophizing Scale
Change in pain catastrophizing as measured by the Pain Catastrophizing Scale (French Canadian version). PCS is a 13-item measure using a 5-point Likert scale (0=not at all, 4=all the time) with score range between 0-52 with decreases in scores meaning better outcome.
Pain Disability Index
Change in pain disability as measured by the The French-Canadian Pain Disability Index (score range is 0-70 with decreases in scores meaning better outcome)
Full Information
NCT ID
NCT04842097
First Posted
April 8, 2021
Last Updated
September 20, 2022
Sponsor
Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal
1. Study Identification
Unique Protocol Identification Number
NCT04842097
Brief Title
Online Mindfulness-based Stress Reduction Intervention for People With Chronic Pain Waiting for Health Services
Official Title
Online Mindfulness-based Stress Reduction Intervention for Chronic Pain in Individuals Waiting for Health Care Services: a Study Protocol for a Pilot Randomized Controlled Trial (RCT)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
June 16, 2021 (Actual)
Primary Completion Date
December 20, 2021 (Actual)
Study Completion Date
January 24, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The goal of this project is to explore the feasibility and the efficacy of a online mindfulness-based stress reduction intervention for people with chronic pain waiting for secondary or tertiary health care services
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
mindfulness-based stress reduction intervention
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A two group parallel single blind pilot RCT
Masking
InvestigatorOutcomes Assessor
Masking Description
It is not possible to blind the participants to group allocation due to the nature of the mindfulness-based stress reduction intervention; however, the outcome assessor, who will administer the outcome questionnaires to the participants will be blinded to the participants' group allocation as well the investigator and the data analyst who will conduct the analysis ensuring neutrality of the outcome assessment.
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mindfulness-based stress reduction intervention
Arm Type
Experimental
Arm Description
Online 8-week group program, once per week
Arm Title
Waiting list
Arm Type
No Intervention
Arm Description
Controls will not receive any intervention during this time. They are on chronic pain clinics waiting list
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness-based stress reduction
Intervention Description
An online mindfulness-based stress reduction intervention will be administered in a group format of maximum 15 participants, once a week for 120 minutes for 8 weeks by an experienced therapist trained in MBSR. Sessions will include sitting and lying meditation, hatha yoga and a body scan where attention is sequentially focused on different parts of the body. Individual autonomous practice between 30-45 minutes, 6 times / week will also be recommended. To support individual autonomous practice, a daily diary and two guided videos (around 35 minutes/each) were created.
Primary Outcome Measure Information:
Title
Participants retention rate
Description
The percentage of participants who have completed the 8 online MBSR sessions
Time Frame
2 months
Title
Participants participation rate
Description
The percentage of participants on waiting lists who agreed to participate in the intervention
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Patient-Reported Outcomes Measurement Information System Global-10
Description
Change in domains of health and functioning as measured by the PROMIS Global-10, score range is 7-35 with increases in scores meaning better outcome
Time Frame
Change from week start of MBSR intervention (week 0) to end of intervention (week 8), 3-month follow-up (week 21)
Title
Patient-Reported Outcomes Measurement Information System 29
Description
Change in 8 health-related quality of life domains as measured by the PROMIS 29. PROMIS-29 is a generic patient reported outcome measure, which includes four items from each of the seven PROMIS domains (physical function, depression, anxiety, fatigue, sleep disturbance, and ability to participate in social roles and activities, pain interference) and a single item on pain intensity. Each item has five response options (values 1 to 5), except for the pain intensity item which has eleven response options (values 0 to 10). A total raw score is computed for each domain as the sum of the response to each question within the domain, leading to seven domain scores, each from 4 to 20.
Time Frame
Change from week start of MBSR intervention (week 0) to end of intervention (week 8), 3-month follow-up (week 21)
Title
French-Canadian Chronic Pain Self-Efficacy Scale
Description
The French-Canadian Chronic Pain Self-Efficacy Scale (Lacasse et al., 2015) is a 6-item scale that measures an individual's confidence in his/her ability to manage chronic pain in general and pain-related symptoms. Items are rated on a 10-point Likert scale ranging from 1 = not at all confident to 10 = entirely confident. Score range is 6-60 with higher scores reflecting greater chronic pain self-efficacy.
Time Frame
Change from week start of MBSR intervention (week 0) to end of intervention (week 8), 3-month follow-up (week 21)
Title
Chronic Pain Acceptance Questionnaire
Description
The Chronic Pain Acceptance Questionnaire (CPAQ-8; Fish et al., 2010 ) is an 8-item scale comprised of two subscales: activity engagement and pain willingness. Items are scored on a 7-point Likert scale ranging from 0 = never true to 6 = always true. Score range is 0-48 with increases in scores meaning better outcome.
Time Frame
Change from week start of MBSR intervention (week 0) to end of intervention (week 8), 3-month follow-up (week 21)
Title
Global Rating of Change Scale
Description
The Global Change Rating Scale (11-point visual analogue scale raging from minus 5 to plus 5) will be used to assess the participants' perception of improvement (or decline) in relation to their self-efficacy in manging pain at the end of the MBSR intervention.
Time Frame
3-month follow-up (week 21)
Title
Pain Catastrophizing Scale
Description
Change in pain catastrophizing as measured by the Pain Catastrophizing Scale (French Canadian version). PCS is a 13-item measure using a 5-point Likert scale (0=not at all, 4=all the time) with score range between 0-52 with decreases in scores meaning better outcome.
Time Frame
Change from week start of MBSR intervention (week 0) to end of intervention (week 8), 3-month follow-up (week 21)
Title
Pain Disability Index
Description
Change in pain disability as measured by the The French-Canadian Pain Disability Index (score range is 0-70 with decreases in scores meaning better outcome)
Time Frame
Change from week start of MBSR intervention (week 0) to end of intervention (week 8), 3-month follow-up (week 21)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Men and women aged 18-85
Self-reported diagnosis of chronic non-cancer pain
Chronic non-cancer pain duration of 3 months or more
Chronic non-cancer pain experienced during 4 days or more per week
Average pain intensity of 4 or more out of 10 in the last seven days
French or English fluency
Access to Wi-Fi
Be able to attend a weekly two-hour MBSR virtual session for eight consecutive weeks
Exclusion Criteria:
Cancer-related chronic pain
Currently receiving or have received in the last 24 months coordinated care in pain clinics, hospitals or rehabilitation centers.
Current or recent participation (in the last 12 months and more than 12 sessions) of cognitive-behavioral therapy or MBSR program
Having an unstable psychological conditions such as depression, bipolar disorder, post-traumatic stress disorder, psychotic disorder
Facility Information:
Facility Name
Association québécoise de la douleur chronique
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1V2C8
Country
Canada
Facility Name
Centre de réadaptation Layton-Lethbridge-Mackay
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4B 1T3
Country
Canada
Facility Name
Hôpital de Verdun
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4G 2A3
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Online Mindfulness-based Stress Reduction Intervention for People With Chronic Pain Waiting for Health Services
We'll reach out to this number within 24 hrs