Online Mindfulness-based Stress Reduction Intervention for People With Chronic Pain Waiting for Health Services
20 septembre 2022 mis à jour par: 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
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
60
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
Quebec
-
Montreal, Quebec, Canada, H1V2C8
- Association québécoise de la douleur chronique
-
Montreal, Quebec, Canada, H4B 1T3
- Centre de réadaptation Layton-Lethbridge-Mackay
-
Montreal, Quebec, Canada, H4G 2A3
- Hôpital de Verdun
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans à 85 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Mindfulness-based stress reduction intervention
Online 8-week group program, once per week
|
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.
|
|
Aucune intervention: Waiting list
Controls will not receive any intervention during this time.
They are on chronic pain clinics waiting list
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Participants retention rate
Délai: 2 months
|
The percentage of participants who have completed the 8 online MBSR sessions
|
2 months
|
|
Participants participation rate
Délai: 12 months
|
The percentage of participants on waiting lists who agreed to participate in the intervention
|
12 months
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Patient-Reported Outcomes Measurement Information System Global-10
Délai: 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
|
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
Délai: 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.
|
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
Délai: 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.
|
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
Délai: 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.
|
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
Délai: 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.
|
3-month follow-up (week 21)
|
|
Pain Catastrophizing Scale
Délai: 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.
|
Change from week start of MBSR intervention (week 0) to end of intervention (week 8), 3-month follow-up (week 21)
|
|
Pain Disability Index
Délai: 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)
|
Change from week start of MBSR intervention (week 0) to end of intervention (week 8), 3-month follow-up (week 21)
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
16 juin 2021
Achèvement primaire (Réel)
20 décembre 2021
Achèvement de l'étude (Réel)
24 janvier 2022
Dates d'inscription aux études
Première soumission
8 avril 2021
Première soumission répondant aux critères de contrôle qualité
8 avril 2021
Première publication (Réel)
13 avril 2021
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
22 septembre 2022
Dernière mise à jour soumise répondant aux critères de contrôle qualité
20 septembre 2022
Dernière vérification
1 septembre 2022
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- CRIR-1499-1120/multi
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .