Online Mindfulness-based Stress Reduction Intervention for People With Chronic Pain Waiting for Health Services
20 de septiembre de 2022 actualizado por: 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
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
60
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Quebec
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Montreal, Quebec, Canadá, H1V2C8
- Association québécoise de la douleur chronique
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Montreal, Quebec, Canadá, H4B 1T3
- Centre de réadaptation Layton-Lethbridge-Mackay
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Montreal, Quebec, Canadá, H4G 2A3
- Hôpital de Verdun
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 85 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 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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Sin intervención: Waiting list
Controls will not receive any intervention during this time.
They are on chronic pain clinics waiting list
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Participants retention rate
Periodo de tiempo: 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
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Patient-Reported Outcomes Measurement Information System Global-10
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
16 de junio de 2021
Finalización primaria (Actual)
20 de diciembre de 2021
Finalización del estudio (Actual)
24 de enero de 2022
Fechas de registro del estudio
Enviado por primera vez
8 de abril de 2021
Primero enviado que cumplió con los criterios de control de calidad
8 de abril de 2021
Publicado por primera vez (Actual)
13 de abril de 2021
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
22 de septiembre de 2022
Última actualización enviada que cumplió con los criterios de control de calidad
20 de septiembre de 2022
Última verificación
1 de septiembre de 2022
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CRIR-1499-1120/multi
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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