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Evaluating a Mindfulness Booster Course for Healthcare Staff (MBCRCT)

1 czerwca 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Rejestracja na zaproszenie

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

186

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Zjednoczone Królestwo
    • West Sussex
      • Worthing, West Sussex, Zjednoczone Królestwo, BN11 1HS
        • Sussex Mindfulness Centre

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Tak

Opis

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 studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Kurs wzmacniający uważność
Behawioralne: 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.
Behawioralne: Usual Care
Participants will be encouraged to continue with whatever activities they usually undertake to manage their stress and support their wellbeing.
Inny: Treatment as usual control
Behawioralne: Usual Care
Participants will be encouraged to continue with whatever activities they usually undertake to manage their stress and support their wellbeing.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Change in Perceived Stress Scale score from baseline (Weeks 0-1) at Weeks 11-12.
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Change in Perceived Stress Scale score from baseline (Weeks 0-1) at Weeks 19-20.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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.

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
Change in the 15-item Five-Facet Mindfulness Questionnaire from baseline (Weeks 0-1) at Weeks 11-12.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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.

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Canterbury Christ Church University

Współpracownicy

Sussex Partnership NHS Foundation Trust

Śledczy

  • Główny śledczy: Fergal W Jones, PhD, PsychD, Canterbury Christ Church University & Sussex Partnership NHS Foundation Trust
  • Krzesło do nauki: Clara Strauss, PhD, DClinPsychol, Sussex Partnership NHS Foundation Trust & University of Sussex
  • Dyrektor Studium: Becky Pearse, BA, MSc, Canterbury Christ Church University & Surrey and Borders Partnership NHS Foundation Trust
  • Dyrektor Studium: Becky Pfaff, BSc, MSc, Canterbury Christ Church University & Surrey and Borders Partnership NHS Foundation Trust
  • Dyrektor Studium: Lila Maleviti, BSc, MSc, Canterbury Christ Church University & Surrey and Borders Partnership NHS Foundation Trust

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

13 maja 2026

Zakończenie podstawowe (Szacowany)

1 marca 2027

Ukończenie studiów (Szacowany)

1 maja 2027

Daty rejestracji na studia

Pierwszy przesłany

24 kwietnia 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

24 kwietnia 2026

Pierwszy wysłany (Rzeczywisty)

1 maja 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

3 czerwca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

1 czerwca 2026

Ostatnia weryfikacja

1 maja 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • ETH2526-0057
  • IRAS 366211 (Inny identyfikator: Health Research Authority (HRA) UK)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Opis planu 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.

Ramy czasowe udostępniania 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.

Kryteria dostępu do udostępniania IPD

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

Typ informacji pomocniczych dotyczących udostępniania IPD

  • PROTOKÓŁ BADANIA

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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