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Completed

NCT Number: NCT04842097

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

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

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Key information

Conditions

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

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Association québécoise de la douleur chronique, Montreal, Quebec, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Participants retention rate

    Time frame: 2 months

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

  2. Participants participation rate

    Time frame: 12 months

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

Secondary outcomes

  1. Patient-Reported Outcomes Measurement Information System Global-10

    Time frame: Change from week start of MBSR intervention (week 0) to end of intervention (week 8), 3-month follow-up (week 21)

    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

  2. Patient-Reported Outcomes Measurement Information System 29

    Time frame: Change from week start of MBSR intervention (week 0) to end of intervention (week 8), 3-month follow-up (week 21)

    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.

  3. French-Canadian Chronic Pain Self-Efficacy Scale

    Time frame: Change from week start of MBSR intervention (week 0) to end of intervention (week 8), 3-month follow-up (week 21)

    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.

  4. Chronic Pain Acceptance Questionnaire

    Time frame: Change from week start of MBSR intervention (week 0) to end of intervention (week 8), 3-month follow-up (week 21)

    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.

  5. Global Rating of Change Scale

    Time frame: 3-month follow-up (week 21)

    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.

  6. Pain Catastrophizing Scale

    Time frame: Change from week start of MBSR intervention (week 0) to end of intervention (week 8), 3-month follow-up (week 21)

    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.

  7. Pain Disability Index

    Time frame: Change from week start of MBSR intervention (week 0) to end of intervention (week 8), 3-month follow-up (week 21)

    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)

Sponsors and collaborators

Lead sponsor

Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal

Other

Registry information

Official study 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)

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Apr 13, 2021
Registry last updated
Sep 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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