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

Browse trials for

• Chronic Pain 2,930

Keywords

• mindfulness-based stress reduction intervention

Chronic Pain

2,930 studies on the registry are indexed under Chronic Pain; 701 are open to participants now.

This study's enrollment of 60 is close to the median of 60 across 2,161 interventional studies indexed under Chronic Pain.

Lead sponsor

Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal is the lead sponsor of 17 studies on the registry; 7 are open to participants now.

Study arms

• Experimental
  Mindfulness-based stress reduction intervention

  Online 8-week group program, once per week

  Behavioral: Mindfulness-based stress reduction

• No intervention
  Waiting list

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

Interventions

• BehavioralMindfulness-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.

Primary outcomes

1. Participants retention rate

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

   Time frame: 2 months

2. Participants participation rate

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

   Time frame: 12 months

Secondary outcomes

1. 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

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

2. 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.

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

3. 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.

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

4. 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.

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

5. 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.

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

6. 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.

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

7. 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)

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

Individual participant data

Plan to share: No