Clinical trial NCT05721716: Examining the Feasibility of a Mindfulness Booster Course for Healthcare Staff Who Attended an 8-week Mindfulness Course
Official title: A Feasibility Randomised Controlled Trial of a Mindfulness Booster Course Following an 8-week Staff Mindfulness Programme
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Lead sponsor: Canterbury Christ Church University
Sponsor class: OTHER
Collaborators: name: Sussex Partnership NHS Foundation Trust
First posted: 2023-02-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to examine the feasibility and acceptability of a mindfulness booster course for UK healthcare staff who have previously participated in an eight-week mindfulness course. The measures of feasibility and acceptability that will be examined include: 1. the ease with which participants are recruited to the clinical trial; 2. the extent to which participants choose to remain in the mindfulness booster course; 3. the extent to which participants choose to remain in the clinical trial; 4. how acceptable the participants find the mindfulness booster course; 5. the level of outcome measure completion; 6. whether there is a preliminary indication that the course may reduce stress. Participants will be randomly allocated to either a mindfulness booster course or a control group, who will be encouraged to continue taking care of their wellbeing as they normally would. Participants will be asked to complete questionnaires at three time-points.

Detailed description: This pilot randomised controlled trial seeks to examine the feasibility and acceptability of a mindfulness booster course for UK National Health Service staff who have previously completed an 8-week mindfulness-based intervention. Participants will be randomised to either the 8-week mindfulness booster course or a control group, in which participants will be encouraged to continue taking care of their wellbeing as they normally would. A battery of self-report measures will be administered online at baseline (weeks 0-1), mid-intervention (week 7), and post-intervention (weeks 11-12). The indices of feasibility and acceptability that will be examined include: 1. ease of recruitment; 2. participant retention in the intervention; 3. participant retention in the study; 4. acceptability of the intervention; 5. outcome measure completion; 6. whether there is a preliminary signal of efficacy on the primary outcome measure (stress). These indices will be compared to progression criteria (which are detailed in the outcome measures section) to determine whether the intervention is sufficiently feasible and acceptable to progress to a full-scale RCT in future research.

Eligibility criteria: Inclusion Criteria:

* UK National Health Service staff member from the South-East, South-West and/or London, including, but not limited to, Sussex Partnership NHS Foundation Trust;
* have completed an 8-week staff mindfulness course within the past three-years (individuals will be considered to have "completed" a mindfulness course if they attended four or more sessions (Simpson et al., 2017; Verweij et al., 2018)).

Exclusion Criteria:

* currently on sick leave;
* planning on undertaking another 8-week mindfulness course;
* have previously found practicing mindfulness distressing.

Primary outcomes:
measure: Number of participants recruited
timeFrame: 10 months following the start of recruitment
measure: Proportion of intervention group participants who attend at least half of the mindfulness booster course intervention sessions
timeFrame: Weeks 0 to 12
measure: Proportion of study participants who remain in the study
timeFrame: Weeks 0 to 12
measure: Mindfulness booster course acceptability
timeFrame: Weeks 11 to 12
measure: Completion rate of the outcome measures
timeFrame: Weeks 0 to 12
measure: Estimate of between group effect size of the mindfulness booster intervention compared to control on the primary outcome measure of change in Perceived Stress Scale scores from baseline (weeks 0-1) to post-intervention (weeks 11-12).
timeFrame: Weeks 11-12
Secondary outcomes:
measure: Estimate of the between group effect size of the mindfulness booster intervention compared to control on change in the 8-item Patient Health Questionnaire (PHQ-8) from baseline (weeks 0-1) to post-intervention (weeks 11-12).
timeFrame: Weeks 11-12
measure: Estimate of the between group effect size of the mindfulness booster intervention compared to control on change in the 7-item Generalised Anxiety Disorder Scale (GAD-7) from baseline (weeks 0-1) to post-intervention (weeks 11-12).
timeFrame: Weeks 11-12
measure: Estimate of the between group effect size of the mindfulness booster intervention compared to control on change in the 15-item Five-Facet Mindfulness Questionnaire (FFMQ-15) from baseline (weeks 0-1) to post-intervention (weeks 11-12).
timeFrame: Weeks 11-12
measure: Estimate of the between group effect size of the mindfulness booster intervention compared to control on change in the Brief Sussex Oxford Compassion to Self Scale (SOCS-S) from baseline (weeks 0-1) to post-intervention (weeks 11-12).
timeFrame: Weeks 11-12
measure: Estimate of the between group effect size of the mindfulness booster intervention compared to control on change in the Brief Compassion for Others Scale (SOCS-O) from baseline (weeks 0-1) to post-intervention (weeks 11-12).
timeFrame: Weeks 11-12
measure: Estimate of the between group effect size of the mindfulness booster intervention compared to control on change in the Short Warwick-Edinburgh Mental Wellbeing Scale (SWEMWS) from baseline (weeks 0-1) to post-intervention (weeks 11-12).
timeFrame: Weeks 11-12
measure: Estimate of the between group effect size of the mindfulness booster intervention compared to control on change in the Sussex Burnout Scale (SBS) from baseline (weeks 0-1) to post-intervention (weeks 11-12).
timeFrame: Weeks 11-12
Other outcomes:
Locations:
city: Hove
country: United Kingdom
facility: Sussex Mindfulness Centre
state: East Sussex
Study officials:
affiliation: Canterbury Christ Church University & Sussex Partnership NHS Foundation Trust
name: Fergal Jones, PhD
role: STUDY_CHAIR
affiliation: Sussex Partnership NHS Foundation Trust & University of Sussex
name: Clara Strauss, DPhil
role: STUDY_DIRECTOR
References: