A Trial of an Online Mindfulness Based Programme for Informal Caregivers of People With Chronic Illnesses
An Exploratory Randomised Pilot Trial Examining the Potential Effectiveness of an Online Mindfulness Based Stress Reduction Programme for Informal Caregivers of People With Chronic Illnesses.
Descripción general del estudio
Descripción detallada
The primary aim of the project is to pilot test the delivery of an online Mindfulness Based Stress Reduction (MBSR) programme to informal caregivers of people with chronic illnesses in one region in Ireland so as to determine the feasibility of delivering the intervention to caregivers in Ireland.
A two-group randomised pilot-feasibility trial comparing the online MBSR programme (intervention) with no programme (control). The MBSR programme is delivered online over 8 weeks. Weekly email and telephone contact will be maintained with participants in the intervention group for the duration of the delivery of the intervention. Participants are encouraged to practice mindfulness exercises and homework between sessions. The online programme was developed by a trained mindfulness teacher and a mindfulness teacher will conduct the weekly email and telephone call to participants in the intervention group. The study sample are caregivers in the Dublin region who are members of Family Carers' Ireland. A total of 80 caregivers will be recruited to the study, 40 per group, based on 1:1 randomisation using a computer-randomised number generator.
Baseline (pre-intervention) and post intervention participant outcome data (stress, mindfulness and QoL) will be collected using self-reported validated scales administered to participants by post, with stamped-addressed envelopes provided for return. Other pilot measures (i.e. study processes) will be monitored and assessed by the research team to determine potential refinement needs. Feasibility outcome data will be collected by the research team (including time to recruit, attendance at classes, willingness of participants to be randomised) and by the participants (expenses diary) during the study period, using predesigned data collection forms. Mean differences with 95% confidence intervals will be calculated to determine any significant differences between the groups on the outcomes of stress, mindfulness and QoL.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
-
Dublin, Irlanda, dublin 2
- Trinity College Dublin
-
Dublin, Irlanda
- Trinity College Dubliln
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Be 18 years of age and over
- Provide unpaid care to an adult or child with a chronic illness
- Not suffer from a severe mental illness
- Be ready to commit to the course at this point in their lives.
Exclusion Criteria:
- Caregivers who are under the age of 18 years.
- Caregivers who have a serious mental illness, such as severe anxiety/depression.
- Caregivers who are in receipt of current and regular treatment from a psychologist or psychiatrist.
- Caregivers with an active or recent physical addiction to alcohol or drugs.
- Caregivers who are already engaged in similar research.
- Caregivers who have already participated in mindfulness based stress reduction (MBSR) or MBCT training.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Sin intervención: Cuidado usual
Sin intervención
|
|
|
Experimental: Mindfulness based Stress Reduction
This is an active intervention The MBSR programme is delivered online with weekly telephone and email contact from a trained mindfulness teacher.
Participants are encouraged to practice mindfulness exercises and homework between sessions.
The online programme was developed be a trained mindfulness teacher.
|
Mindfulness is a skill that helps people manage their thoughts so that the stressful impact of unhelpful thoughts can be limited.
The aim of the mindfulness based intervention in this study is to help caregivers manage stressful thoughts and events and help them respond to life stressors in a positive way.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change over time in Calgary Symptoms of Stress Inventory (C-SOSI)
Periodo de tiempo: up to 2 weeks and 6 months post-intervention
|
Response to stressful situations
|
up to 2 weeks and 6 months post-intervention
|
|
Change over time in Perceived Stress Scale
Periodo de tiempo: up to 2 weeks and 6 months post-intervention
|
perceived stress
|
up to 2 weeks and 6 months post-intervention
|
|
Change over time in Cognitive and Affective Mindfulness Scale Revised (CAMS-R)
Periodo de tiempo: up to 2 weeks and 6 months post-intervention
|
Mindfulness
|
up to 2 weeks and 6 months post-intervention
|
|
Change over time in The Adult Carer Quality of Life Questionnaire
Periodo de tiempo: up to 2 weeks and 6 months post-intervention
|
Quality of Life
|
up to 2 weeks and 6 months post-intervention
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Caregiver MBCT Programme Evaluation Form
Periodo de tiempo: up to 2 weeks post-intervention
|
programme evaluation
|
up to 2 weeks post-intervention
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Margarita Corry, University of Dublin, Trinity College
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 12 (Israel lung Association)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre MBSR
-
Indiana UniversityIndiana University HealthTerminadoDolor de pecho | Ansiedad | Atención plenaEstados Unidos
-
Cecile LengacherTerminado
-
Universiti Sains MalaysiaTerminadoDepresión ansiedad | Cancer de cabeza y cuello | Psico-OncologíaMalasia
-
California Pacific Medical Center Research InstituteNational Center for Complementary and Integrative Health (NCCIH); Kaiser Permanente y otros colaboradoresTerminadoDolor crónico | MigrañaEstados Unidos
-
University of AarhusDesconocido
-
Yale UniversityTerminadoSíndrome metabólicoEstados Unidos
-
Henry M. Jackson Foundation for the Advancement...DesconocidoTBI (lesión cerebral traumática) | Insomnio crónicoEstados Unidos
-
US Department of Veterans AffairsEmory UniversityTerminadoTEPT | Trastornos De Estrés PostraumáticoEstados Unidos
-
University of AarhusCopenhagen University Hospital, HvidovreTerminadoEmbarazo, Alto RiesgoDinamarca
-
Kahramanmaras Sutcu Imam UniversityAún no reclutandoMujeres infértiles o mujeres con insuficiencia ovárica | Mujeres Embarazadas Previas al PartoTurquía (Türkiye)