Duchemin 2015.

Study characteristics
Methods	Study design: RCT Study grouping: parallel group Unit of randomisation: individuals Power (power sample size calculation, level of power achieved): not specified; small sample size as limitation Imputation of missing data: no missing data; intention‐to‐treat analysis
Participants	Country: USA Setting: large academic medical centre (SICU) Age: mean = 44.2 years Sample size (randomised): 32 Sex: 28 women, 4 men Comorbidity (mean (SD) of respective measures in indicated, if available at baseline: perceived stress (PSS): 12% of participants with low stress (< 10), 37% with high stress (> 16); stress scale: 37% with cut‐off value of stress > 14; burnout‐emotional exhaustion (MBI): 28% with cut‐off score > 26; burnout‐depersonalisation: 7.78 (5.53); burnout‐personal accomplishment: 36.5 (7.449) Population description: personnel, 18 years or older, from the SICU of a large academic medical centre Inclusion criteria: 1) any personnel working in the SICU; 2) having contact with the patients or their families Exclusion criteria: 1) individuals practising mindfulness, yoga, or exercising more than 30 minutes a day; 2) individuals with third trimester pregnancy; 3) individuals with a history of recent surgery if it limited ability to perform the gentle yoga movements Attrition (withdrawals and exclusions): no withdrawals or exclusions Reasons for missing data: not applicable since no missing data
Interventions	Intervention: workplace‐adapted mindfulness‐based intervention (MBI) (n = 16) delivery: face‐to‐face group sessions; CDs provided to participants to facilitate daily practice providers: delivered by M. Klatt, trained mindfulness and certified yoga instructor, who developed the MBI to be pragmatically performed in a work setting duration of treatment period and timing: 8 weekly sessions; all sessions of 1‐hour length except for week 5 (2 hours) that includes mindful eating; participants asked to perform 20‐minute daily individual practice if possible description: combination of didactic introduction/discussion and combination of mindfulness and yoga practices with music at each session; protocol combines elements of mindfulness meditation, yoga movements, and relaxation through music CONTENT: after introduction of the weekly theme/prompt, participants are led through a body scan, gentle stretching, yoga, progressive relaxation, and/or an eating meditation (for the 2‐hour session), and then into formal meditation; each week a different topic is highlighted; music is standardised to be the same background music in each session, and in the background of each meditation practice contained on CDs compliance: not specified integrity of delivery: not specified economic information: intervention provided free of charge; work coverage assured for the participants during the time of the group sessions and assessments theoretical basis: intervention is 8 weeks in length, paralleling the mindfulness‐based‐stress‐reduction (MBSR) traditional programme, with shortening of the group session duration for the setting; low‐dose 8‐week workplace adapted MBI (Klatt 2009; Malarkey 2013) Control: wait‐list control (n = 16)
Outcomes	Outcomes collected and reported: perceived stress ‐ PSS stress ‐ stress scale of DASS burnout, emotional exhaustion ‐ MBI burnout, depersonalisation ‐ MBI burnout, personal accomplishment MBI compassion fatigue ‐ ProQOL ‐ only correlations between ProQOL total score and other outcome variables reported secondary traumatisation ‐ ProQOL ‐only correlations between ProQOL total score and other outcome variables reported risk of burnout ‐ ProQOL ‐ only correlations between ProQOL total score and other outcome variables reported mindfulness, observing ‐ FFMQ mindfulness, describing ‐ FFMQ mindfulness, acting with awareness ‐ FFMQ mindfulness, non‐judging of inner experience ‐ FFMQ mindfulness, non‐reactivity to inner experience ‐ FFMQ salivary alpha‐amylase ‐ Salivette® Time points measured and reported: 1) pre‐intervention (1 week before intervention); 2) post‐intervention (1 week after intervention) Adverse events: not specified
Notes	Contact with authors: We contacted authors to ask for the means and SDs for all outcomes for the 2 groups at pre‐ and post‐intervention and to inquire whether FFMQ and ProQOL were measured as outcomes or only correlates. Data for some outcomes were sent by the authors (perceived stress, DASS‐21 stress, work stress, salivary alpha‐amylase, work satisfaction) of which not all were specified in the report (work satisfaction) (Klatt 2018 [pers comm]). Study start/end date: not specified Funding source: funded in part by the OSU Harding Behavioral Health Stress, Trauma and Resilience program Declaration of interest: none declared Ethical approval needed/obtained for study: approved by the university IRB, and all participants provided signed informed consent Comments by authors: not specified Miscellaneous outcomes by the review authors: conference abstract Klatt 2012 is a second reference to this study Correspondence: Anne‐Marie Duchemin, Department of Psychiatry, The Ohio State University, 1670 Upham Drive, Columbus, Ohio 43210, USA; anne‐marie.duchemin@osumc.edu; Tel: 614‐293‐5517, Fax: 614‐293‐7599
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "The study adhered to the CONSORT guidelines for randomized trials 23. Eligible participants were randomized 1:1 using Graphpad software to intervention group or waiting list control group, with stratification by gender and type of work." Quote: "There were no significant differences between the two groups for age (p = 0.9496, t= 0.0638), years of experience (p = 0.9485, t = 0.06512), or years working in the SICU (p = 0.8702, t = 0.1648)." Quote: "On the PSS, only 12% of participants had a score < 10 (low stress), while 37% had a score > 16 (high stress). There was no significant difference between the two groups at baseline (p = 0.0910, t = 1.746)." Quote: "On the DASS stress subscale, 37% had score > 14, the cut‐off value for stress, with no significant difference between the two groups (p = 0.1552, t = 1.458)." Quote: "On the Maslach’s burnout inventory, the average emotional exhaustion subscale score was 23.12±10.1 with 28% of participants having scores > 26 and no difference between intervention and control groups (p = 0.3185, t = 1.0124)." Quote: "The scores were 7.78±5.53 for depersonalization and 36.5±7.449 for personal accomplishment with no significant difference between the groups (p = 0.685, t = 0.4909 and p = 0.3508, t = 0.9477 respectively)." Quote: "The average value for all participants was 93.6 ±15.9 units/ml (mean ± SEM) with no difference between the two groups (p = 0.6812, t = 0.4152)." (salivary α amylase) Quote: "Participants scored the stress level of their work at 7.15 ± 1.89 on a scale of 1 to 10 (with 10 being most stressful) at baseline with no significant difference between the two groups (p=0.8833, t= 0.1480)." Judgement comment: The investigators describe a random component in the sequence generation process (randomisation via software) and there is verified baseline comparability between groups for sociodemographic characteristics (age, years of experience, years working in SICU) and some outcomes of interest for the review on the basis of analysis.; baseline comparability between groups in mindfulness and burnout (ProQOL) unclear
Allocation concealment (selection bias)	Unclear risk	Judgement comment: insufficient information about allocation concealment to permit judgement of ‘Low risk’ or ‘High risk’
Blinding of participants and personnel (performance bias) Objective outcomes	Low risk	Judgement comment: blinding of participants and personnel probably not done (face‐to‐face intervention), but the review authors judge that the outcome is not likely to be influenced by lack of blinding
Blinding of participants and personnel (performance bias) Subjective outcomes	High risk	Judgement comment: blinding of participants and personnel probably not done (face‐to‐face intervention) and the outcome is likely to be influenced by lack of blinding
Blinding of outcome assessment (detection bias) Objective outcomes	Low risk	Judgement comment: insufficient information about blinding of outcome assessment, but the review authors judge that the outcome measurement is not likely to be influenced by lack of blinding
Blinding of outcome assessment (detection bias) Subjective outcomes	High risk	Judgement comment: insufficient information about blinding of outcome assessment; however, due to potential performance bias (no blinding of participants), the review authors judge that the participants' responses to questionnaires may be affected by the lack of blinding (i.e. knowledge and beliefs about intervention they received)
Incomplete outcome data (attrition bias) All outcomes	Low risk	Quote: "There was no drop‐out and all participants completed the 2 sets of assessments." Quote: "Intention to treat “analyses which included all subjects randomized were performed." Judgement comment: no missing outcome data
Selective reporting (reporting bias)	High risk	Judgement comment: no study protocol available, but not all of the study's prespecified outcomes have been reported (for ProQOF and FFMQ only correlations with other outcomes reported but no intervention effects in contrast to other outcomes)