Evaluating a Mindfulness Booster Course for Healthcare Staff

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.

• Change in Perceived Stress Scale score from baseline (Weeks 0-1) at Weeks 19-20. [Time frame: 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. [Time frame: 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. [Time frame: 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. [Time frame: 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. [Time frame: 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. [Time frame: 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. [Time frame: Baseline (Weeks 0-1) and Weeks 19-20.]
• Change in Sussex Burnout Scale score from baseline (Weeks 0-1) at Weeks 11-12. [Time frame: Baseline (Weeks 0-1) and Weeks 11-12.]
• Change in Sussex Burnout Scale score from baseline (Weeks 0-1) at Weeks 19-20. [Time frame: Baseline (Weeks 0-1) and Weeks 19-20.]