Online Mindfulness-based Stress Reduction Intervention for People With Chronic Pain Waiting for Health Services

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)

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

Study Overview

• Status: Completed
• Conditions: Chronic Pain
• Intervention / Treatment: Behavioral: Mindfulness-based stress reduction

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H1V2C8
      • Association québécoise de la douleur chronique
    • Montreal, Quebec, Canada, H4B 1T3
      • Centre de réadaptation Layton-Lethbridge-Mackay
    • Montreal, Quebec, Canada, H4G 2A3
      • Hôpital de Verdun

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mindfulness-based stress reduction intervention; Online 8-week group program, once per week	Behavioral: Mindfulness-based stress reduction; 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.
No Intervention: Waiting list; Controls will not receive any intervention during this time. They are on chronic pain clinics waiting list

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participants retention rate	The percentage of participants who have completed the 8 online MBSR sessions	2 months
Participants participation rate	The percentage of participants on waiting lists who agreed to participate in the intervention	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Change from week start of MBSR intervention (week 0) to end of intervention (week 8), 3-month follow-up (week 21)
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.	Change from week start of MBSR intervention (week 0) to end of intervention (week 8), 3-month follow-up (week 21)
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.	Change from week start of MBSR intervention (week 0) to end of intervention (week 8), 3-month follow-up (week 21)
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.	Change from week start of MBSR intervention (week 0) to end of intervention (week 8), 3-month follow-up (week 21)
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.	3-month follow-up (week 21)
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.	Change from week start of MBSR intervention (week 0) to end of intervention (week 8), 3-month follow-up (week 21)
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)	Change from week start of MBSR intervention (week 0) to end of intervention (week 8), 3-month follow-up (week 21)

Collaborators and Investigators

• Sponsor: Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal

Study record dates

Study Major Dates

• Study Start (Actual): June 16, 2021
• Primary Completion (Actual): December 20, 2021
• Study Completion (Actual): January 24, 2022

Study Registration Dates

• First Submitted: April 8, 2021
• First Submitted That Met QC Criteria: April 8, 2021
• First Posted (Actual): April 13, 2021

Study Record Updates

• Last Update Posted (Actual): September 22, 2022
• Last Update Submitted That Met QC Criteria: September 20, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: mindfulness-based stress reduction intervention
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: CRIR-1499-1120/multi

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No