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

NCT04842097 | Completed

• 1 other identifier: CRIR-1499-1120/multi
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

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

Conditions

Chronic Pain

Keywords

mindfulness-based stress reduction intervention

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• 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)

• 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)

• 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)

• Global Rating of Change Scale

  3-month follow-up (week 21)

Study Arms (2)

Mindfulness-based stress reduction intervention

EXPERIMENTAL

Online 8-week group program, once per week

Behavioral: Mindfulness-based stress reduction

Waiting list

NO INTERVENTION

Controls will not receive any intervention during this time. They are on chronic pain clinics waiting list

Interventions

Mindfulness-based stress reduction BEHAVIORAL

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.

Mindfulness-based stress reduction intervention

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (3)

Association québécoise de la douleur chronique

Montreal, Quebec, H1V2C8, Canada

Location

Centre de réadaptation Layton-Lethbridge-Mackay

Montreal, Quebec, H4B 1T3, Canada

Location

Hôpital de Verdun

Montreal, Quebec, H4G 2A3, Canada

Location

MeSH Terms

Conditions

Chronic Pain

Interventions

Mindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: site researcher

Model Details: A two group parallel single blind pilot RCT

Study Record Dates

• First Submitted: April 8, 2021
• First Posted: April 13, 2021
• Study Start: June 16, 2021
• Primary Completion: December 20, 2021
• Study Completion: January 24, 2022
• Last Updated: September 22, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (3)