Online Mindfulness-based Stress Reduction Intervention for People With Chronic Pain Waiting for Health Services
20 september 2022 bijgewerkt door: Diana Zidarov, Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal
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
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Werkelijk)
60
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Quebec
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Montreal, Quebec, Canada, H1V2C8
- Association québécoise de la douleur chronique
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Montreal, Quebec, Canada, H4B 1T3
- Centre de réadaptation Layton-Lethbridge-Mackay
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Montreal, Quebec, Canada, H4G 2A3
- Hôpital de Verdun
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar tot 85 jaar (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: Mindfulness-based stress reduction intervention
Online 8-week group program, once per week
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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.
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Geen tussenkomst: Waiting list
Controls will not receive any intervention during this time.
They are on chronic pain clinics waiting list
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Participants retention rate
Tijdsspanne: 2 months
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The percentage of participants who have completed the 8 online MBSR sessions
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2 months
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Participants participation rate
Tijdsspanne: 12 months
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The percentage of participants on waiting lists who agreed to participate in the intervention
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12 months
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Patient-Reported Outcomes Measurement Information System Global-10
Tijdsspanne: Change from week start of MBSR intervention (week 0) to end of intervention (week 8), 3-month follow-up (week 21)
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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
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Change from week start of MBSR intervention (week 0) to end of intervention (week 8), 3-month follow-up (week 21)
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Patient-Reported Outcomes Measurement Information System 29
Tijdsspanne: Change from week start of MBSR intervention (week 0) to end of intervention (week 8), 3-month follow-up (week 21)
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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.
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Change from week start of MBSR intervention (week 0) to end of intervention (week 8), 3-month follow-up (week 21)
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French-Canadian Chronic Pain Self-Efficacy Scale
Tijdsspanne: Change from week start of MBSR intervention (week 0) to end of intervention (week 8), 3-month follow-up (week 21)
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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.
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Change from week start of MBSR intervention (week 0) to end of intervention (week 8), 3-month follow-up (week 21)
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Chronic Pain Acceptance Questionnaire
Tijdsspanne: Change from week start of MBSR intervention (week 0) to end of intervention (week 8), 3-month follow-up (week 21)
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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.
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Change from week start of MBSR intervention (week 0) to end of intervention (week 8), 3-month follow-up (week 21)
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Global Rating of Change Scale
Tijdsspanne: 3-month follow-up (week 21)
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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.
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3-month follow-up (week 21)
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Pain Catastrophizing Scale
Tijdsspanne: Change from week start of MBSR intervention (week 0) to end of intervention (week 8), 3-month follow-up (week 21)
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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.
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Change from week start of MBSR intervention (week 0) to end of intervention (week 8), 3-month follow-up (week 21)
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Pain Disability Index
Tijdsspanne: Change from week start of MBSR intervention (week 0) to end of intervention (week 8), 3-month follow-up (week 21)
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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)
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Change from week start of MBSR intervention (week 0) to end of intervention (week 8), 3-month follow-up (week 21)
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
16 juni 2021
Primaire voltooiing (Werkelijk)
20 december 2021
Studie voltooiing (Werkelijk)
24 januari 2022
Studieregistratiedata
Eerst ingediend
8 april 2021
Eerst ingediend dat voldeed aan de QC-criteria
8 april 2021
Eerst geplaatst (Werkelijk)
13 april 2021
Updates van studierecords
Laatste update geplaatst (Werkelijk)
22 september 2022
Laatste update ingediend die voldeed aan QC-criteria
20 september 2022
Laatst geverifieerd
1 september 2022
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- CRIR-1499-1120/multi
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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