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Evaluating a Mindfulness Booster Course for Healthcare Staff (MBCRCT)

1 giugno 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Iscrizione su invito

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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 di studio

Interventistico

Iscrizione (Stimato)

186

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Regno Unito
    • West Sussex
      • Worthing, West Sussex, Regno Unito, BN11 1HS
        • Sussex Mindfulness Centre

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

Sì

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Corso Mindfulness Booster
Comportamentale: 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.
Comportamentale: Usual Care
Participants will be encouraged to continue with whatever activities they usually undertake to manage their stress and support their wellbeing.
Altro: Treatment as usual control
Comportamentale: Usual Care
Participants will be encouraged to continue with whatever activities they usually undertake to manage their stress and support their wellbeing.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Perceived Stress Scale score from baseline (Weeks 0-1) at Weeks 11-12.
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Perceived Stress Scale score from baseline (Weeks 0-1) at Weeks 19-20.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in the 15-item Five-Facet Mindfulness Questionnaire from baseline (Weeks 0-1) at Weeks 11-12.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Canterbury Christ Church University

Collaboratori

Sussex Partnership NHS Foundation Trust

Investigatori

  • Investigatore principale: Fergal W Jones, PhD, PsychD, Canterbury Christ Church University & Sussex Partnership NHS Foundation Trust
  • Cattedra di studio: Clara Strauss, PhD, DClinPsychol, Sussex Partnership NHS Foundation Trust & University of Sussex
  • Direttore dello studio: Becky Pearse, BA, MSc, Canterbury Christ Church University & Surrey and Borders Partnership NHS Foundation Trust
  • Direttore dello studio: Becky Pfaff, BSc, MSc, Canterbury Christ Church University & Surrey and Borders Partnership NHS Foundation Trust
  • Direttore dello studio: Lila Maleviti, BSc, MSc, Canterbury Christ Church University & Surrey and Borders Partnership NHS Foundation Trust

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

13 maggio 2026

Completamento primario (Stimato)

1 marzo 2027

Completamento dello studio (Stimato)

1 maggio 2027

Date di iscrizione allo studio

Primo inviato

24 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

24 aprile 2026

Primo Inserito (Effettivo)

1 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

3 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

1 giugno 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • ETH2526-0057
  • IRAS 366211 (Altro identificatore: Health Research Authority (HRA) UK)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano 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.

Periodo di condivisione 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.

Criteri di accesso alla condivisione IPD

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

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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