Clinical trial NCT04842097: 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
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Keywords: mindfulness-based stress reduction intervention
Lead sponsor: Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal
Sponsor class: OTHER
First posted: 2021-04-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A two group parallel single blind pilot RCT
Primary purpose: SUPPORTIVE_CARE

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


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

Primary outcomes:
measure: Participants retention rate
timeFrame: 2 months
measure: Participants participation rate
timeFrame: 12 months
Secondary outcomes:
measure: Patient-Reported Outcomes Measurement Information System Global-10
timeFrame: Change from week start of MBSR intervention (week 0) to end of intervention (week 8), 3-month follow-up (week 21)
measure: Patient-Reported Outcomes Measurement Information System 29
timeFrame: Change from week start of MBSR intervention (week 0) to end of intervention (week 8), 3-month follow-up (week 21)
measure: French-Canadian Chronic Pain Self-Efficacy Scale
timeFrame: Change from week start of MBSR intervention (week 0) to end of intervention (week 8), 3-month follow-up (week 21)
measure: Chronic Pain Acceptance Questionnaire
timeFrame: Change from week start of MBSR intervention (week 0) to end of intervention (week 8), 3-month follow-up (week 21)
measure: Global Rating of Change Scale
timeFrame: 3-month follow-up (week 21)
measure: Pain Catastrophizing Scale
timeFrame: Change from week start of MBSR intervention (week 0) to end of intervention (week 8), 3-month follow-up (week 21)
measure: Pain Disability Index
timeFrame: Change from week start of MBSR intervention (week 0) to end of intervention (week 8), 3-month follow-up (week 21)
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Association québécoise de la douleur chronique
state: Quebec
city: Montreal
country: Canada
facility: Centre de réadaptation Layton-Lethbridge-Mackay
state: Quebec
city: Montreal
country: Canada
facility: Hôpital de Verdun
state: Quebec
Study officials:
References: