Examining the Feasibility of a Mindfulness Booster Course for Healthcare Staff Who Attended an 8-week Mindfulness Course

August 2, 2023 updated by: Canterbury Christ Church University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United Kingdom
    • East Sussex
      • Hove, East Sussex, United Kingdom, BN3 4AG
        • Sussex Mindfulness Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Mindfulness Booster Course
Behavioral: 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 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.
Behavioral: Usual care
Participants will be encouraged to continue with whatever activities they usually undertake to manage their stress and support their wellbeing.
Other: Treatment as Usual Control
Behavioral: Usual care
Participants will be encouraged to continue with whatever activities they usually undertake to manage their stress and support their wellbeing.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
10 months following the start of recruitment
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%.
Weeks 0 to 12
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%.
Weeks 0 to 12
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
Weeks 11 to 12
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%.
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).
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.
Weeks 11-12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
The 8-item Patient Health Questionnaire (PHQ-8) is a self-report measure of depression, with higher scores indicating greater levels of depression symptoms.
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
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.
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
The 15-item Five-Facet Mindfulness Questionnaire (FFMQ-15) is a self-report measure of mindfulness, with higher scores indicating greater levels of mindfulness.
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
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.
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
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.
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
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.
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
The Sussex Burnout Scale (SBS) is a self-report measure of burnout, with higher scores indicating greater levels of burnout.
Weeks 11-12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Canterbury Christ Church University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Sussex Partnership NHS Foundation Trust

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Fergal Jones, PhD, Canterbury Christ Church University & Sussex Partnership NHS Foundation Trust
  • Study Director: Clara Strauss, DPhil, Sussex Partnership NHS Foundation Trust & University of Sussex

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 20, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 1, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 1, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 10, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 3, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 2, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DClinPsychol21KWalker

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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