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

NCT05721716 | Completed

• 1 other identifier: DClinPsychol21KWalker
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress

Outcome Measures

Primary Outcomes (6)

• 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.

  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%.

  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%.

  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

  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%.

  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.

  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).

  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).

  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).

  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).

  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).

  Weeks 11-12

Study Arms (2)

Mindfulness Booster Course

EXPERIMENTAL

Behavioral: Mindfulness Booster Course; Behavioral: Usual care

Treatment as Usual Control

OTHER

Behavioral: Usual care

Interventions

Mindfulness Booster Course BEHAVIORAL

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.

Mindfulness Booster Course

Usual care BEHAVIORAL

Participants will be encouraged to continue with whatever activities they usually undertake to manage their stress and support their wellbeing.

Mindfulness Booster Course; Treatment as Usual Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)).

You may not qualify if:

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

Sponsors & Collaborators

• Canterbury Christ Church University: lead
• Sussex Partnership NHS Foundation Trust: collaborator

Study Sites (1)

Sussex Mindfulness Centre

Hove, East Sussex, BN3 4AG, United Kingdom

Location

Study Officials

• Fergal Jones, PhD

  Canterbury Christ Church University & Sussex Partnership NHS Foundation Trust

  STUDY CHAIR

• Clara Strauss, DPhil

  Sussex Partnership NHS Foundation Trust & University of Sussex

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Assessment of outcome will be by self-report measures administered by an online survey. Therefore, assessment of outcome will be masked from the researchers, but not the participants themselves.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2023
• First Posted: February 10, 2023
• Study Start: March 20, 2023
• Primary Completion: August 1, 2023
• Study Completion: August 1, 2023
• Last Updated: August 3, 2023

Record last verified: 2023-08

Locations

GB (1)