Feasibility Randomised Controlled Trial Exploring Implementation of the Compassionate Mindful rEsilience pRogram for People With pUlmonaRY Fibrosis: The MERcURY Study (MERcURY)
Pulmonary fibrosis (PF) is a chronic lung condition in which scar tissue gradually forms, impairing oxygen transfer and causing breathlessness. Individuals with PF frequently experience anxiety and depression, yet supportive care remains underdeveloped, and few evidence-based psychological interventions exist for this population, representing a critical gap in care.
This feasibility randomised controlled trial (RCT) evaluated the Compassionate Mindful Resilience (CMR) programme, a 4-week online, nurse-led mindfulness-based intervention designed to improve psychological outcomes in people living with PF.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Background: Pulmonary fibrosis is a progressive, irreversible fibrotic lung disease that requires long-term treatment. People with a diagnosis of pulmonary fibrosis are known to have reduced health-related quality of life, furthermore, it is common for such individuals to experience anxiety and depression. Therefore, interventions to support these individuals are essential to improve their psychological health. Mindfulness is increasing in popularity but retention in these programmes can be challenging. Condensed programmes have great potential but require statistical and individual evaluation. The Compassionate Mindful Resilience Program is a 4-week course that teaches simple, effective, evidence-based practices, skills and techniques.
Methods: This study aims to establish the feasibility of a randomised controlled trial to evaluate the effectiveness of the Compassionate Mindful Resilience Program in improving the psychosocial well-being of people with a diagnosis of pulmonary fibrosis. The trial will be conducted to test procedures, outcomes and validated tools; estimate recruitment and attrition rates; and calculate the sample size required for a future definitive multi-centre randomised controlled trial. The study will also utilise qualitative methods to explore the acceptability of the intervention to the study population. In keeping with CONSORT guidelines. The SPIRIT guidelines and checklist will be utilised to report the study.
Discussion: This study will implement a four-week mindfulness intervention and its utility for people with Pulmonary Fibrosis. The investigators aim to increase equitable access to evidence-based mindfulness practices with the potential to improve the lives of people impacted by this condition. If the study demonstrates the practicability of delivering the online 4-week Compassionate Mindful Resilience program with adequate recruitment, the investigators will be able to determine the feasibility of progression to a randomised controlled clinical trial to increase equitable access to evidence-based mindfulness practices with the potential to improve the lives of people impacted by Pulmonary Fibrosis.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Please Select
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Belfast, Please Select, Reino Unido, BT7 1NN
- Queen's University Belfast
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- have a confirmed diagnosis of PF
- be aged 18 years or older
- reside in the UK or Ireland
- have the capacity to provide informed consent
- demonstrate a commitment to attend all four CMR sessions (demonstrated through discussion with the mindfulness teacher during screening)
- have access to an internet-enabled device.
Exclusion Criteria:
- No diagnosis of PF
- under 18 years old
- live outside of UK or Ireland
- no capacity to provide informed consent
- not willing to attend all four CMR sessions
- no access to an internet-enabled device.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Intervention group
CMR is an internationally accredited 4-week programme with 2-hour online sessions delivered via Microsoft Teams
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It is an internationally accredited 4-week programme with 2-hour online sessions delivered via Microsoft Teams
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Sin intervención: Waitlist group
This group did not receive the CMR intervention until all intervention groups had completed CMR.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Feasibility of the intervention
Periodo de tiempo: From enrollment until the follow up interview was completed (up to 10 weeks)
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Adherence
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From enrollment until the follow up interview was completed (up to 10 weeks)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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The feasibility of collecting data on anxiety, depression, well-being, mindfulness, resilience, and self-compassion
Periodo de tiempo: Baseline (week 1), post-CMR (week 4), and four-week follow-up (week 8)
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These were measured via online surveys at baseline, post-CMR, and four-week follow-up
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Baseline (week 1), post-CMR (week 4), and four-week follow-up (week 8)
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Feasibility of recruitment and retention
Periodo de tiempo: From recruitment until the end of the study (up to 5 months)
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Measured against pre-defined recruitment and retention targets
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From recruitment until the end of the study (up to 5 months)
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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Publicaciones Generales
- Mc Veigh C, Reid J, Larkin P, Porter S, Hudson P. Palliative care for people with non-malignant respiratory disease and their carers: a review of the current evidence. J Res Nurs. 2019 Sep;24(6):420-430. doi: 10.1177/1744987119840066. Epub 2019 Apr 29.
- Mc Veigh C, Reid J, Larkin P, Porter S, Hudson P. The experience of palliative care service provision for people with non-malignant respiratory disease and their family carers: An all-Ireland qualitative study. J Adv Nurs. 2018 Feb;74(2):383-394. doi: 10.1111/jan.13453. Epub 2017 Nov 27.
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 (Actual)
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- MHLS 24_139
- SB\ZA\101010662\980079 (Otro número de subvención/financiamiento: The Burdett Trust)
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.
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