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Evaluating a Mindfulness Booster Course for Healthcare Staff (MBCRCT)

1 de junio de 2026 actualizado por: Canterbury Christ Church University

A Randomized Controlled Trial of an 8-Week Mindfulness "Booster" Course for Staff: Examining Effectiveness, Mediators of Impact, and Participant Experiences

The goal of this clinical trial is to learn if a mindfulness booster course can reduce stress in healthcare staff who have previously attended a mindfulness course. The main questions it aims to answer are:

  • Is a mindfulness booster course for healthcare staff effective at reducing their stress levels?
  • Are any benefits maintained for 8 weeks?

Researchers will compare a mindfulness booster course with usual care to see if it helps to reduce stress. Participants will take part in either a mindfulness booster course or do what they usually do to look after their wellbeing. They will complete questionnaires at the beginning, middle and end of the study.

Descripción general del estudio

Estado

Inscripción por invitación

Condiciones

Intervención / Tratamiento

Descripción detallada

Aims:

  1. To determine whether the mindfulness booster course for healthcare staff is effective in terms of the primary outcome (perceived stress) and secondary outcomes (wellbeing, depression, burnout, and compassion for others), and whether any benefits are maintained at follow-up.
  2. To examine whether any effects on the above-mentioned outcomes are statistically mediated by changes in amount of mindfulness practice, rumination and worry, decentering, self-compassion, and trait mindfulness.
  3. To develop an abbreviated grounded theory of the therapeutic process and outcomes of the mindfulness booster course.

Hypotheses:

  1. a) The primary hypothesis is that we will see a significantly greater decrease in the primary outcome of perceived stress at post-intervention (the primary time-point of Weeks 11-12) relative to baseline (Weeks 0-1) for the 'mindfulness-booster course plus treatment as usual (TAU)' intervention group compared to the 'TAU-only' control group.

    b) Our secondary hypothesis is that we will see significantly greater improvements in each of our secondary outcome measures at post-intervention (Weeks 11-12) relative to baseline for our intervention group compared to our control group. Improvements entail decreases in depression and burnout and increases in compassion for others and wellbeing.

    c) Our third hypothesis is that we will also see the effects detailed in (1a) and (1b) above at the follow-up time-point (Weeks 19-20).

  2. a) The relationship between group allocation (intervention vs. control) and reduction in perceived stress, from baseline to follow-up (Weeks 19-20), will be statistically mediated by changes from baseline to post-intervention in the following psychological constructs: i) increase in amount of mindfulness practice, both formal and informal; ii) reduction in rumination and worry, i.e., repetitive negative thinking; iii) increase in decentering; iv) increase in self-compassion; v) increase in trait mindfulness.

    b) The relationships specified in Hypothesis 2a will also hold true for the secondary outcomes (i.e. change from baseline to follow-up [Weeks 19-20] in wellbeing, depression, burnout and compassion for others).

    c) i) The relationship between group allocation and reduction in perceived stress will be serially statistically as follows: intervention group allocation predicts increased mindfulness practice (from baseline to post-intervention [Weeks 11-12]) which in turn predicts change in psychological mechanisms (i.e., rumination/worry, decentering, self-compassion and trait mindfulness; from baseline to post-intervention [Weeks 11-12]), which in turn predict reduced perceived stress (from baseline to follow-up [Weeks 19-20]).

    ii) The relationships specified in Hypothesis 2c-i will also hold for the secondary outcomes (i.e. change from baseline to follow-up [Weeks 19-20] in wellbeing, depression, burnout and compassion for others).

    Design Information Not Included Elsewhere in this Registration:

    After Weeks 11-12, a subsample of intervention group participants will be invited to participate in a semi-structured individual interview, with the qualitative data being collected and analysed according to grounded theory principles. This aspect of the study has the following sub-aims:

    1. To explore what processes occur during the mindfulness booster course, based on participants' experiences.
    2. To explore how these processes interact with the participants' contexts, including, but not limited to, working in healthcare.
    3. To explore how these processes and contexts interact with, and perhaps drive, any perceived impacts and outcomes of the course.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

186

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

  • Reino Unido
    • West Sussex
      • Worthing, West Sussex, Reino Unido, BN11 1HS
        • Sussex Mindfulness Centre

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

Sí

Descripción

Inclusion Criteria:

  • UK National Health Service staff member.
  • Has completed an 8-week mindfulness course (either MBCT, MBCT-L or MBSR). Individuals will be considered to have "completed" a mindfulness course if they attended four or more sessions.
  • Is able to make one of the planned sets of times for the booster course sessions, in case they are randomly allocated to the intervention arm.

Exclusion Criteria:

  • Currently on sick leave.
  • Planning on undertaking another 8-week mindfulness course.
  • Previously participated in the mindfulness booster course in the feasibility study.
  • Have previously found practising mindfulness distressing.

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: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Curso de refuerzo de atención plena
Conductual: Mindfulness Booster Course
The mindfulness booster course will consist of eight 30-minute sessions, which participants will be asked to commit to. These will be online and usually occur weekly. Within these sessions, there will be a 15-minute mindfulness practice followed by a 15-minute discussion. This discussion time will involve reflecting on the mindfulness practice and speaking about between-session practice. Participants will be encouraged to practice mindfulness for home work between the sessions.
Conductual: Usual Care
Participants will be encouraged to continue with whatever activities they usually undertake to manage their stress and support their wellbeing.
Otro: Treatment as usual control
Conductual: Usual Care
Participants will be encouraged to continue with whatever activities they usually undertake to manage their stress and support their wellbeing.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Perceived Stress Scale score from baseline (Weeks 0-1) at Weeks 11-12.
Periodo de tiempo: Baseline (Weeks 0-1) and Weeks 11-12
The 10-item Perceived Stress Scale (PSS-10) is a self-report measure of perceived stress, which produces a score ranging between 0 and 40. A higher score indicates greater perceived stress.
Baseline (Weeks 0-1) and Weeks 11-12

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Perceived Stress Scale score from baseline (Weeks 0-1) at Weeks 19-20.
Periodo de tiempo: Baseline (Weeks 0-1) and Weeks 19-20
The 10-item Perceived Stress Scale (PSS-10) is a self-report measure of perceived stress, which produces a score ranging between 0 and 40. A higher score indicates greater perceived stress.
Baseline (Weeks 0-1) and Weeks 19-20
Change in 8-item Patient Health Questionnaire score from baseline (Weeks 0-1) at Weeks 11-12.
Periodo de tiempo: Baseline (Weeks 0-1) and Weeks 11-12.
The 8-item Patient Health Questionnaire (PHQ-8) is a self-report measure of depression, which produces a score ranging between 0 and 24. A higher score indicates a greater level of depression symptoms.
Baseline (Weeks 0-1) and Weeks 11-12.
Change in 8-item Patient Health Questionnaire score from baseline (Weeks 0-1) at Weeks 19-20.
Periodo de tiempo: Baseline (Weeks 0-1) and Weeks 19-20
The 8-item Patient Health Questionnaire (PHQ-8) is a self-report measure of depression, which produces a score ranging between 0 and 24. A higher score indicates a greater level of depression symptoms.
Baseline (Weeks 0-1) and Weeks 19-20
Change in Brief Sussex-Oxford Compassion for Others Scale score from baseline (Weeks 0-1) at Weeks 11-12.
Periodo de tiempo: Baseline (Weeks 0-1) and Weeks 11-12.
The Brief Sussex-Oxford Compassion for Others Scale (SOCS-O) is a 5-item, self-report measure of compassion for others, which produces a score ranging between 5 and 25. A higher score indicates greater compassion for others.
Baseline (Weeks 0-1) and Weeks 11-12.
Change in Brief Sussex-Oxford Compassion for Others Scale score from baseline (Weeks 0-1) at Weeks 19-20.
Periodo de tiempo: Baseline (Weeks 0-1) and Weeks 19-20
The Brief Sussex-Oxford Compassion for Others Scale (SOCS-O) is a 5-item, self-report measure of compassion for others, which produces a score ranging between 5 and 25. A higher score indicates greater compassion for others.
Baseline (Weeks 0-1) and Weeks 19-20
Change in Sussex Burnout Scale score from baseline (Weeks 0-1) at Weeks 11-12.
Periodo de tiempo: Baseline (Weeks 0-1) and Weeks 11-12.
The Sussex Burnout Scale (SBS) is a 3-item self-report measure of burnout, which produces a score ranging between 3 and 15. A higher score indicates a greater level of burnout.
Baseline (Weeks 0-1) and Weeks 11-12.
Change in Sussex Burnout Scale score from baseline (Weeks 0-1) at Weeks 19-20.
Periodo de tiempo: Baseline (Weeks 0-1) and Weeks 19-20.
The Sussex Burnout Scale (SBS) is a 3-item self-report measure of burnout, which produces a score ranging between 3 and 15. A higher score indicates a greater level of burnout.
Baseline (Weeks 0-1) and Weeks 19-20.
Change in Short Warwick-Edinburgh Mental Wellbeing Scale score from baseline (Weeks 0-1) at Weeks 11-12.
Periodo de tiempo: Baseline (Weeks 0-1) and Weeks 11-12.
The Short Warwick-Edinburgh Mental Wellbeing Scale (SWEMWBS) is a 7-item self-report measure of mental wellbeing, which produces a score ranging between 7 and 35. A higher score indicates a greater level of mental wellbeing.
Baseline (Weeks 0-1) and Weeks 11-12.
Change in Short Warwick-Edinburgh Mental Wellbeing Scale score from baseline (Weeks 0-1) at Weeks 19-20.
Periodo de tiempo: Baseline (Weeks 0-1) and Weeks 19-20.
The Short Warwick-Edinburgh Mental Wellbeing Scale (SWEMWBS) is a 7-item self-report measure of mental wellbeing, which produces a score ranging between 7 and 35. A higher score indicates a greater level of mental wellbeing.
Baseline (Weeks 0-1) and Weeks 19-20.

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in the 15-item Five-Facet Mindfulness Questionnaire from baseline (Weeks 0-1) at Weeks 11-12.
Periodo de tiempo: Baseline (Weeks 0-1) and Weeks 11-12.
The 15-item Five-Facet Mindfulness Questionnaire (FFMQ-15) is a self-report measure of mindfulness, which produces a score ranging between 15 and 75. A higher score indicates a greater level of mindfulness.
Baseline (Weeks 0-1) and Weeks 11-12.
Change in the Brooding Subscale of the Ruminative Response Scale from baseline (Weeks 0-1) at Weeks 11-12.
Periodo de tiempo: Baseline (Weeks 0-1) and Weeks 11-12.
The 5-item Brooding Subscale of the Ruminative Response Scale (RRS-B) is a self-report measure of brooding rumination, which produces a score ranging between 5 and 20. A higher score indicates a greater level of brooding rumination.
Baseline (Weeks 0-1) and Weeks 11-12.
Change in the 8-item version of the Penn State Worry Questionnaire from baseline (Weeks 0-1) at Weeks 11-12.
Periodo de tiempo: Baseline (Weeks 0-1) and Weeks 11-12.
The 8-item Penn State Worry Questionnaire (PSWQ-A) is a self-report measure of worry, which produces a score ranging between 8 and 40. A higher score indicates a greater level of worry.
Baseline (Weeks 0-1) and Weeks 11-12.
Change in the Decentering Scale of the Experiences Questionnaire from baseline (Weeks 0-1) at Weeks 11-12.
Periodo de tiempo: Baseline (Weeks 0-1) and Weeks 11-12.
The 11-item Decentering Scale of the Experiences Questionnaire (EQ-D) is a self-report measure of decentering, which produces a score ranging between 11 and 55. A higher score indicates a greater ability to decenter.
Baseline (Weeks 0-1) and Weeks 11-12.
Change in Brief Sussex-Oxford Compassion to Self Scale score from baseline (Weeks 0-1) at Weeks 11-12.
Periodo de tiempo: Baseline (Weeks 0-1) and Weeks 11-12.
The Brief Sussex-Oxford Compassion to Self Scale (SOCS-S) is a 5-item, self-report measure of compassion for the self, which produces a score ranging between 5 and 25. A higher score indicates greater compassion towards oneself.
Baseline (Weeks 0-1) and Weeks 11-12.
Change in the average amount of time spent practicing mindfulness from baseline (Weeks 0-1) at Weeks 11-12.
Periodo de tiempo: Baseline (Weeks 0-1) and Weeks 11-12.
A bespoke, self-report questionnaire will measure the amount of mindfulness practice undertaken, on average, per week, in minutes. Separate averages will be calculated for formal and informal mindfulness practice.
Baseline (Weeks 0-1) and Weeks 11-12.

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Canterbury Christ Church University

Colaboradores

Sussex Partnership NHS Foundation Trust

Investigadores

  • Investigador principal: Fergal W Jones, PhD, PsychD, Canterbury Christ Church University & Sussex Partnership NHS Foundation Trust
  • Silla de estudio: Clara Strauss, PhD, DClinPsychol, Sussex Partnership NHS Foundation Trust & University of Sussex
  • Director de estudio: Becky Pearse, BA, MSc, Canterbury Christ Church University & Surrey and Borders Partnership NHS Foundation Trust
  • Director de estudio: Becky Pfaff, BSc, MSc, Canterbury Christ Church University & Surrey and Borders Partnership NHS Foundation Trust
  • Director de estudio: Lila Maleviti, BSc, MSc, Canterbury Christ Church University & Surrey and Borders Partnership NHS Foundation Trust

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)

13 de mayo de 2026

Finalización primaria (Estimado)

1 de marzo de 2027

Finalización del estudio (Estimado)

1 de mayo de 2027

Fechas de registro del estudio

Enviado por primera vez

24 de abril de 2026

Primero enviado que cumplió con los criterios de control de calidad

24 de abril de 2026

Publicado por primera vez (Actual)

1 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

3 de junio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

1 de junio de 2026

Última verificación

1 de mayo de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • ETH2526-0057
  • IRAS 366211 (Otro identificador: Health Research Authority (HRA) UK)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

All outcome measure IPD will be made publicly available. Some or all demographic IPD may be excluded to prevent jigsaw identification of participants. An assessmment of what, if any, demographic IPD can be included will be made once the data have been collected and the risk of participant identification assessed.

Marco de tiempo para compartir IPD

These will be made available after the study findings have been published in peer reviewed journals and, in any event, no more than 3 years after study completion.

Criterios de acceso compartido de IPD

These will be made publicly available on the internet at access at https://pure.canterbury.ac.uk/en/persons/fergal-jones-2/

Tipo de información de apoyo para compartir IPD

  • PROTOCOLO DE ESTUDIO

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

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. .

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