Chronic PainNCT04842097
Online Mindfulness-based Stress Reduction Intervention for People With Chronic Pain Waiting for Health Services
A study testing Mindfulness-based stress reduction in people with Chronic Pain, run by Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal at 3 sites in Canada.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Mindfulness-based stress reduction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 3 sitesCanada
- Study dates
- 16 Jun 2021to 24 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Association québécoise de la douleur chronique
Montreal, Quebec, H1V2C8
Centre de réadaptation Layton-Lethbridge-Mackay
Montreal, Quebec, H4B 1T3
Hôpital de Verdun
Montreal, Quebec, H4G 2A3
About this study
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)
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
- Being tested
- Mindfulness-based stress reduction
- Keywords
- mindfulness-based stress reduction intervention
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-based stress reductionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness-based stress reduction intervention | Experimental | Online 8-week group program, once per week Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants retention rate
The percentage of participants who have completed the 8 online MBSR sessions
Measured: 2 months
Participants participation rate
The percentage of participants on waiting lists who agreed to participate in the intervention
Measured: 12 months
Secondary outcomes (7)
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
Measured: 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 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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 3-month follow-up (week 21)
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.
Measured: 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 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)
Measured: Change from week start of MBSR intervention (week 0) to end of intervention (week 8), 3-month follow-up (week 21)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2021
- Study start16 Jun 2021
- Primary completion20 Dec 2021
- Study completion24 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A two group parallel single blind pilot RCT
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Diana Zidarov, Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04842097
- Sponsor's protocol ID
- CRIR-1499-1120/multi
- Status last verified
- Sep 2022
- First submitted
- 8 Apr 2021
- Last updated
- 22 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04842097
- Acronym / sponsor ID
- CRIR-1499-1120/multi
- Conditions
- Chronic Pain
- Keywords
- mindfulness-based stress reduction intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Centre for Interdisciplinary Research in Rehabilitation of Greater MontrealUniversity, hospital or other
- Study start
- 16 Jun 2021 (actual)
- Primary completion
- 20 Dec 2021 (actual)
- Study completion
- 24 Jan 2022 (actual)
- First posted
- 13 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A two group parallel single blind pilot RCT
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-based stress reduction intervention | Experimental | Behavioral: Mindfulness-based stress reductionOnline 8-week group program, once per week |
| Waiting list | No intervention | –Controls will not receive any intervention during this time. They are on chronic pain clinics waiting list |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness-based stress reductionAn 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. | Behavioural | Mindfulness-based stress reduction intervention |
Primary outcome
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
7 secondary outcomes
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)
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)
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)
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)
Global Rating of Change Scale
Time frame: 3-month follow-up (week 21)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-based stress reduction in people with Chronic Pain, run by Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal at 3 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participants retention rate (time frame: 2 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2022.