Online Mindfulness-Based Cognitive Therapy for People With Multiple Sclerosis With Mild-Moderate Depression
28 de julio de 2026 actualizado por: Robert Simpson
Online Mindfulness-Based Cognitive Therapy for People With Multiple Sclerosis With Mild-Moderate Depression: A Hybrid Effectiveness-Implementation Study
This study will use a waiting list randomized controlled trial design with a mixed-methods research approach, including both quantitative and qualitative methods. Randomization helps minimize research bias and controls for participant and contextual factors that might otherwise make interpretation of results challenging. We will recruit 152 people with multiple sclerosis (PwMS) with any type of MS, who also have mild-moderate depression, aged 18 or greater, and able to understand spoken and written English.
For the quantitative part, we will examine how much change in depression there is following mindfulness-based cognitive therapy (MBCT), as well as whether participants attend the course and complete study measures or not, and how much participants complete MBCT home practices. We will also examine how much change there is in fatigue, sleep pain, quality of life, and anxiety.
For the qualitative part of the study, we will use semi-structured interviews to explore participant experiences of online MBCT, how people used online MBCT, what worked, what didn't and why, how online MBCT impacted self-management of depression, and suggestions for improving the course to make it more relevant for PwMS with depression.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
152
Fase
- Fase 3
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.
Estudio Contacto
- Nombre: Robert Simpson
- Número de teléfono: 416-978-8383
- Correo electrónico: rab.simpson@utoronto.ca
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
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
Inclusion criteria will include:
- Age >/=18
- Neurologist confirmed MS diagnosis (McDonald criteria)
- Able to understand spoken and written English
- A score of 14-28 on the Beck Depression Inventory-II signifying mild-moderate depression
- Registered with a primary care provider (family physician or neurologist)
- Residing in Canada
Exclusion criteria will include:
- Potentially life-threatening comorbidities (suicidal ideation (i.e., score of 2 or 3 on the BDI-Fast Screen suicidal ideation question), history of psychosis, terminal/life threatening inter-current illness), or those such conditions expected to significantly limit participation and adherence (pregnancy, cognitive impairment i.e. score <26 on the Montreal Cognitive Assessment - MoCA)
- Receipt of MBCT in the past 2 years (completed at least 4/8 sessions).
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: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Mindfulness-Based Cognitive Therapy
Online group Mindfulness-Based Cognitive Therapy delivered live online in weekly sessions for 8 weeks
|
Online group Mindfulness-Based Cognitive Therapy delivered live online in weekly sessions for 8 weeks
|
|
Sin intervención: Waitlist control
Waitlist control arm - participants receive no intervention initially but receive MBCT following data collection
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Depression
Periodo de tiempo: Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)
|
Change in depression scores using the Hospital Anxiety and Depression Scale
|
Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Self-efficacy
Periodo de tiempo: Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)
|
Self-efficacy, as measured by the Generalized Self-Efficacy Scale
|
Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)
|
|
Self-management
Periodo de tiempo: Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)
|
Self-management, as measured by the Multiple-Sclerosis Self-Management Scale-Revised
|
Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)
|
|
Stigma
Periodo de tiempo: Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)
|
Stigma, as measured by the Stigma Scale for Chronic Illness-8
|
Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)
|
|
Fatigue
Periodo de tiempo: Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)
|
Fatigue as measured by the Modified Fatigue Impact Scale
|
Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)
|
|
Sleep
Periodo de tiempo: Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)
|
Sleep as measured by the Insomnia Severity Index
|
Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)
|
|
Change in pain
Periodo de tiempo: Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)
|
Pain as measured by the Pain Effects Scale
|
Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)
|
|
Change in quality of life
Periodo de tiempo: Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)
|
Quality of life as measured by the Multiple Sclerosis Impact Scale-29
|
Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)
|
|
Anxiety
Periodo de tiempo: Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)
|
Anxiety as measured by Hospital Anxiety and Depression Scale -Anxiety
|
Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)
|
|
Mindfulness
Periodo de tiempo: Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)
|
Mindfulness as measured by The Five-facet Mindfulness Questionnaire
|
Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)
|
|
Self-compassion
Periodo de tiempo: Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)
|
Self-compassion, measured using the The Self-Compassion Scale-short form
|
Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)
|
|
Emotion regulation
Periodo de tiempo: Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)
|
Emotion regulation, as measured by The Difficulties with Emotional Regulation Scale short-form
|
Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)
|
|
Group attendance
Periodo de tiempo: Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)
|
Group attendance in those allocated to tailored online MBCT
|
Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)
|
|
Group climate
Periodo de tiempo: Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)
|
Group climate using the Climate Questionnaire-Engage Scale
|
Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)
|
|
Therapeutic alliance
Periodo de tiempo: Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)
|
Therapeutic alliance as measured by the Working Alliance Inventory
|
Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)
|
|
Depressive symptoms
Periodo de tiempo: Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)
|
Depressive symptoms as measured by the Beck Depression Inventory II (BDI-II)
|
Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)
|
|
Implementation
Periodo de tiempo: Throughout the study and up to 12 months post-intervention
|
Implementation, as informed by the Proctor's taxonomy
|
Throughout the study and up to 12 months post-intervention
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
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 (Estimado)
1 de agosto de 2026
Finalización primaria (Estimado)
1 de noviembre de 2028
Finalización del estudio (Estimado)
1 de diciembre de 2028
Fechas de registro del estudio
Enviado por primera vez
23 de julio de 2026
Primero enviado que cumplió con los criterios de control de calidad
28 de julio de 2026
Publicado por primera vez (Actual)
3 de agosto de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
3 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
28 de julio de 2026
Última verificación
1 de enero de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades del Sistema Nervioso
- Enfermedades autoinmunes
- Enfermedades del sistema inmunológico
- Enfermedades Autoinmunes Desmielinizantes, SNC
- Enfermedades Autoinmunes del Sistema Nervioso
- Enfermedades desmielinizantes
- Esclerosis múltiple
- Terapia conductual
- Psicoterapia
- Disciplinas y actividades de comportamiento
- Terapia cognitiva conductual
- Consciencia
- Terapia cognitiva basada en la atención plena
Otros números de identificación del estudio
- 00049655
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
INDECISO
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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