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Evaluating a Mindfulness Booster Course for Healthcare Staff (MBCRCT)

maanantai 1. kesäkuuta 2026 päivittänyt: 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.

Tutkimuksen yleiskatsaus

Tila

Ilmoittautuminen kutsusta

Ehdot

Interventio / Hoito

Yksityiskohtainen kuvaus

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.

Opintotyyppi

Interventio

Ilmoittautuminen (Arvioitu)

186

Vaihe

  • Ei sovellettavissa

Yhteystiedot ja paikat

Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.

Opiskelupaikat

  • Yhdistynyt kuningaskunta
    • West Sussex
      • Worthing, West Sussex, Yhdistynyt kuningaskunta, BN11 1HS
        • Sussex Mindfulness Centre

Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

  • Aikuinen
  • Vanhempi Aikuinen

Hyväksyy terveitä vapaaehtoisia

Joo

Kuvaus

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.

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

  • Ensisijainen käyttötarkoitus: Hoito
  • Jako: Satunnaistettu
  • Inventiomalli: Rinnakkaistehtävä
  • Naamiointi: Ei mitään (avoin tarra)

Aseet ja interventiot

Osallistujaryhmä / Arm
Interventio / Hoito
Kokeellinen: Mindfulness Booster -kurssi
Käyttäytyminen: 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.
Käyttäytyminen: Usual Care
Participants will be encouraged to continue with whatever activities they usually undertake to manage their stress and support their wellbeing.
Muut: Treatment as usual control
Käyttäytyminen: Usual Care
Participants will be encouraged to continue with whatever activities they usually undertake to manage their stress and support their wellbeing.

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Change in Perceived Stress Scale score from baseline (Weeks 0-1) at Weeks 11-12.
Aikaikkuna: 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

Toissijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Change in Perceived Stress Scale score from baseline (Weeks 0-1) at Weeks 19-20.
Aikaikkuna: 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.
Aikaikkuna: 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.
Aikaikkuna: 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.
Aikaikkuna: 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.
Aikaikkuna: 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.
Aikaikkuna: 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.
Aikaikkuna: 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.
Aikaikkuna: 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.
Aikaikkuna: 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.

Muut tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Change in the 15-item Five-Facet Mindfulness Questionnaire from baseline (Weeks 0-1) at Weeks 11-12.
Aikaikkuna: 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.
Aikaikkuna: 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.
Aikaikkuna: 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.
Aikaikkuna: 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.
Aikaikkuna: 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.
Aikaikkuna: 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.

Yhteistyökumppanit ja tutkijat

Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.

Sponsori

Canterbury Christ Church University

Yhteistyökumppanit

Sussex Partnership NHS Foundation Trust

Tutkijat

  • Päätutkija: Fergal W Jones, PhD, PsychD, Canterbury Christ Church University & Sussex Partnership NHS Foundation Trust
  • Opintojen puheenjohtaja: Clara Strauss, PhD, DClinPsychol, Sussex Partnership NHS Foundation Trust & University of Sussex
  • Opintojohtaja: Becky Pearse, BA, MSc, Canterbury Christ Church University & Surrey and Borders Partnership NHS Foundation Trust
  • Opintojohtaja: Becky Pfaff, BSc, MSc, Canterbury Christ Church University & Surrey and Borders Partnership NHS Foundation Trust
  • Opintojohtaja: Lila Maleviti, BSc, MSc, Canterbury Christ Church University & Surrey and Borders Partnership NHS Foundation Trust

Opintojen ennätyspäivät

Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan ​​julkisella verkkosivustolla.

Opi tärkeimmät päivämäärät

Opiskelun aloitus (Todellinen)

Keskiviikko 13. toukokuuta 2026

Ensisijainen valmistuminen (Arvioitu)

Maanantai 1. maaliskuuta 2027

Opintojen valmistuminen (Arvioitu)

Lauantai 1. toukokuuta 2027

Opintoihin ilmoittautumispäivät

Ensimmäinen lähetetty

Perjantai 24. huhtikuuta 2026

Ensimmäinen toimitettu, joka täytti QC-kriteerit

Perjantai 24. huhtikuuta 2026

Ensimmäinen Lähetetty (Todellinen)

Perjantai 1. toukokuuta 2026

Tutkimustietojen päivitykset

Viimeisin päivitys julkaistu (Todellinen)

Keskiviikko 3. kesäkuuta 2026

Viimeisin lähetetty päivitys, joka täytti QC-kriteerit

Maanantai 1. kesäkuuta 2026

Viimeksi vahvistettu

Perjantai 1. toukokuuta 2026

Lisää tietoa

Tähän tutkimukseen liittyvät termit

Avainsanat

Muita asiaankuuluvia MeSH-ehtoja

Muut tutkimustunnusnumerot

  • ETH2526-0057
  • IRAS 366211 (Muu tunniste: Health Research Authority (HRA) UK)

Yksittäisten osallistujien tietojen suunnitelma (IPD)

Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?

JOO

IPD-suunnitelman kuvaus

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.

IPD-jaon aikakehys

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.

IPD-jaon käyttöoikeuskriteerit

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

IPD-jakamista tukeva tietotyyppi

  • STUDY_PROTOCOL

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