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)

Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal3 sites in 1 country60 target enrollmentJune 16, 2021

ConditionsChronic Pain

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Chronic Pain
Sponsor: Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal
Enrollment: 60
Locations: 3
Primary Endpoint: Participants retention rate
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

June 16, 2021

End Date

January 24, 2022

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal

Responsible Party

Principal Investigator

Diana Zidarov

site researcher

Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal

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

Outcomes

Primary Outcomes

Participants retention rate

Time Frame: 2 months

The percentage of participants who have completed the 8 online MBSR sessions

Participants participation rate

Time Frame: 12 months

The percentage of participants on waiting lists who agreed to participate in the intervention

Secondary Outcomes

Patient-Reported Outcomes Measurement Information System 29(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(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(3-month follow-up (week 21))
Chronic Pain Acceptance Questionnaire(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 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 Global-10(Change from week start of MBSR intervention (week 0) to end of intervention (week 8), 3-month follow-up (week 21))
Pain Catastrophizing Scale(Change from week start of MBSR intervention (week 0) to end of intervention (week 8), 3-month follow-up (week 21))