StressNCT05721716
Examining the Feasibility of a Mindfulness Booster Course for Healthcare Staff Who Attended an 8-week Mindfulness Course
A study testing Mindfulness Booster Course in people with Stress, run by Canterbury Christ Church University at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress
- What is being tested?
- Mindfulness Booster Course
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 Mar 2023to 1 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)).
Who cannot join
- currently on sick leave;
- planning on undertaking another 8-week mindfulness course;
- have previously found practicing mindfulness distressing.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Sussex Mindfulness Centre
Hove, East Sussex, BN3 4AG
About this study
Official title: A Feasibility Randomised Controlled Trial of a Mindfulness Booster Course Following an 8-week Staff Mindfulness Programme
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.
Read the 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.
- Conditions
- Stress
- Being tested
- Mindfulness Booster Course, Usual care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness Booster CourseBehavioural
The mindfulness booster course will consist of eight 30-minute sessions, which participants will be asked to commit to. These will be online and occur weekly for 8-weeks. 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.
Usual careBehavioural
Participants will be encouraged to continue with whatever activities they usually undertake to manage their stress and support their wellbeing.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness Booster Course | Experimental | Not described Receives: Behavioral: Mindfulness Booster Course; Behavioral: Usual care |
| Treatment as Usual Control | Other | Not described Receives: Behavioral: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants recruited
The number of participants recruited over 10-months will be compared against the following progression criterion to assess the feasibility of recruitment: Green: 40-50; Amber 24-39; Red: <24.
Measured: 10 months following the start of recruitment
Proportion of intervention group participants who attend at least half of the mindfulness booster course intervention sessions
The proportion of participants who attend at least half of the intervention sessions will be compared against the following progression criterion to assess retention in the intervention: Green: ≥50%; Amber 25-49%; Red: <25%.
Measured: Weeks 0 to 12
Proportion of study participants who remain in the study
The proportion of study participants who remain in the study will be compared against the following progression criterion to assess retention in the study: Green: ≥50%; Amber 25-49%; Red: <25%.
Measured: Weeks 0 to 12
Mindfulness booster course acceptability
Response to Likert type questions and content analysis of qualitative data will be compared against the following progression criterion to assess retention in the study: Green: the majority of intervention participants report the intervention is acceptable as it is or with minor adjustments; Amber: there are inconsistent reports of acceptability or the intervention requires bigger adjustments; Red: the majority of intervention participants report the intervention is unacceptable or requires adjustments which cannot be completed
Measured: Weeks 11 to 12
Completion rate of the outcome measures
The rate of the outcome measures completion will be compared against the following progression criterion to assess the feasibility of outcome measurement: Green: ≥60%; Amber 40-59%; Red: <40%.
Measured: Weeks 0 to 12
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).
The estimated 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) will be compared against the following progression criterion to provide a preliminary indicator of effectiveness: Green: effect size in favour of intervention arm and 95% confidence interval for that effect size contains (or is greater than) the minimal clinically important difference found by Drachev et al. (2020). Amber: effect size is in favour of control, but the minimum clinically important difference is included in the 95% confidence interval; Red: effect size is in favour of control, and the minimum clinically important difference is not included in the 95% confidence interval.
Measured: Weeks 11-12
Secondary outcomes (7)
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).
The 8-item Patient Health Questionnaire (PHQ-8) is a self-report measure of depression, with higher scores indicating greater levels of depression symptoms.
Measured: Weeks 11-12
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).
The 7-item Generalised Anxiety Disorder Scale (GAD-7) is a self-report measure of generalised anxiety, with higher scores indicating greater levels of generalized anxiety symptoms.
Measured: Weeks 11-12
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).
The 15-item Five-Facet Mindfulness Questionnaire (FFMQ-15) is a self-report measure of mindfulness, with higher scores indicating greater levels of mindfulness.
Measured: Weeks 11-12
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).
The Brief Sussex Oxford Compassion to Self Scale (SOCS-S) is a self-report measure of self-compassion, with higher scores indicating greater levels of self-compassion.
Measured: Weeks 11-12
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).
The Brief Compassion for Others Scale (SOCS-O) is a self-report measure of compassion for others, with higher scores indicating greater levels of compassion.
Measured: Weeks 11-12
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).
The Short Warwick-Edinburgh Mental Wellbeing Scale (SWEMWS) is a self-report measure of mental wellbeing, with higher scores indicating greater levels of mental wellbeing.
Measured: Weeks 11-12
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).
The Sussex Burnout Scale (SBS) is a self-report measure of burnout, with higher scores indicating greater levels of burnout.
Measured: Weeks 11-12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2023
- Study start20 Mar 2023
- Primary completion1 Aug 2023
- Study completion1 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Canterbury Christ Church University
- Sponsor type
- University, hospital or other
- Collaborators
- Sussex Partnership NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Fergal Jones, PhD, Study chair, Canterbury Christ Church University & Sussex Partnership NHS Foundation TrustClara Strauss, DPhil, Study director, Sussex Partnership NHS Foundation Trust & University of Sussex
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05721716
- Sponsor's protocol ID
- DClinPsychol21KWalker
- Status last verified
- Aug 2023
- First submitted
- 1 Feb 2023
- Last updated
- 3 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Randomised Controlled Trial of a Mindfulness Booster Course Following an 8-week Staff Mindfulness Programme
- ClinicalTrials.gov ID
- NCT05721716
- Acronym / sponsor ID
- DClinPsychol21KWalker
- Conditions
- Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Canterbury Christ Church UniversityUniversity, hospital or other
- Collaborators
- Sussex Partnership NHS Foundation Trust
- Study start
- 20 Mar 2023 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 1 Aug 2023 (actual)
- First posted
- 10 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness Booster Course | Experimental | Behavioral: Mindfulness Booster Course, Behavioral: Usual care |
| Treatment as Usual Control | Other | Behavioral: Usual care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)).
Key exclusion criteria (3 listed)
- currently on sick leave;
- planning on undertaking another 8-week mindfulness course;
- have previously found practicing mindfulness distressing.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness Booster CourseThe mindfulness booster course will consist of eight 30-minute sessions, which participants will be asked to commit to. These will be online and occur weekly for 8-weeks. 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. | Behavioural | Mindfulness Booster Course |
| Usual careParticipants will be encouraged to continue with whatever activities they usually undertake to manage their stress and support their wellbeing. | Behavioural | Mindfulness Booster Course, Treatment as Usual Control |
Primary outcome
Number of participants recruited
Time frame: 10 months following the start of recruitment
The number of participants recruited over 10-months will be compared against the following progression criterion to assess the feasibility of recruitment: Green: 40-50; Amber 24-39; Red: <24.
Proportion of intervention group participants who attend at least half of the mindfulness booster course intervention sessions
Time frame: Weeks 0 to 12
The proportion of participants who attend at least half of the intervention sessions will be compared against the following progression criterion to assess retention in the intervention: Green: ≥50%; Amber 25-49%; Red: <25%.
Proportion of study participants who remain in the study
Time frame: Weeks 0 to 12
The proportion of study participants who remain in the study will be compared against the following progression criterion to assess retention in the study: Green: ≥50%; Amber 25-49%; Red: <25%.
Mindfulness booster course acceptability
Time frame: Weeks 11 to 12
Response to Likert type questions and content analysis of qualitative data will be compared against the following progression criterion to assess retention in the study: Green: the majority of intervention participants report the intervention is acceptable as it is or with minor adjustments; Amber: there are inconsistent reports of acceptability or the intervention requires bigger adjustments; Red: the majority of intervention participants report the intervention is unacceptable or requires adjustments which cannot be completed
Completion rate of the outcome measures
Time frame: Weeks 0 to 12
The rate of the outcome measures completion will be compared against the following progression criterion to assess the feasibility of outcome measurement: Green: ≥60%; Amber 40-59%; Red: <40%.
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).
Time frame: Weeks 11-12
The estimated 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) will be compared against the following progression criterion to provide a preliminary indicator of effectiveness: Green: effect size in favour of intervention arm and 95% confidence interval for that effect size contains (or is greater than) the minimal clinically important difference found by Drachev et al. (2020). Amber: effect size is in favour of control, but the minimum clinically important difference is included in the 95% confidence interval; Red: effect size is in favour of control, and the minimum clinically important difference is not included in the 95% confidence interval.
7 secondary outcomes
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).
Time frame: Weeks 11-12
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).
Time frame: Weeks 11-12
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).
Time frame: Weeks 11-12
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).
Time frame: Weeks 11-12
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).
Time frame: Weeks 11-12
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).
Time frame: Weeks 11-12
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).
Time frame: Weeks 11-12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fergal Jones, PhD study chair
Canterbury Christ Church University & Sussex Partnership NHS Foundation Trust
Clara Strauss, DPhil study director
Sussex Partnership NHS Foundation Trust & University of Sussex
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Booster Course in people with Stress, run by Canterbury Christ Church University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants recruited (time frame: 10 months following the start of recruitment). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2023.