Online Mindfulness-based Stress Reduction Intervention for People With Chronic Pain Waiting for Health Services
20 september 2022 uppdaterad av: 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
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
60
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Quebec
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Montreal, Quebec, Kanada, H1V2C8
- Association québécoise de la douleur chronique
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Montreal, Quebec, Kanada, H4B 1T3
- Centre de réadaptation Layton-Lethbridge-Mackay
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Montreal, Quebec, Kanada, H4G 2A3
- Hôpital de Verdun
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-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 85 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: 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.
|
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Inget ingripande: Waiting list
Controls will not receive any intervention during this time.
They are on chronic pain clinics waiting list
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Participants retention rate
Tidsram: 2 months
|
The percentage of participants who have completed the 8 online MBSR sessions
|
2 months
|
|
Participants participation rate
Tidsram: 12 months
|
The percentage of participants on waiting lists who agreed to participate in the intervention
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12 months
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Patient-Reported Outcomes Measurement Information System Global-10
Tidsram: 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
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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
Tidsram: 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.
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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
Tidsram: 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.
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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
Tidsram: 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.
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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
Tidsram: 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
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
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Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
16 juni 2021
Primärt slutförande (Faktisk)
20 december 2021
Avslutad studie (Faktisk)
24 januari 2022
Studieregistreringsdatum
Först inskickad
8 april 2021
Först inskickad som uppfyllde QC-kriterierna
8 april 2021
Första postat (Faktisk)
13 april 2021
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
22 september 2022
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
20 september 2022
Senast verifierad
1 september 2022
Mer information
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Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- CRIR-1499-1120/multi
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