Reilly‐Spong 2015.

Study characteristics
Methods	Study design Parallel RCT Study dates Duration of follow‐up: 6 months (but after kidney transplantation (2, 6 and 12 months) will be analysed for efficacy, as reported in Reilly‐Spong 2015) Time frame: January 2010 to March 2012. Follow‐up for post‐transplant outcomes ended June 2014
Participants	Study characteristics Setting: multicentre (university transplant centre and dialysis clinics) Country: USA Inclusion criteria: adults with progressive kidney disease eligible for kidney or kidney‐pancreas transplant; ≥ 18 years; able to read and write in English; interested in attending the workshops; able to use a telephone for teleconferences Exclusion criteria: prior transplant; prior MBSR or regular meditation practice; serious mental health concerns (suicidally, psychotic disorder, or substance abuse identified on screening by a psychologist); hospitalised or medically unstable (e.g. recent stroke); kidney transplant scheduled within the next 3 months Baseline characteristics Number (analysed/randomised): intervention group (15/18); control group (14/19) HD: intervention group (not reported/11); control group (not reported/13) PD: intervention group (not reported/4); control group (not reported/1) Mean age ± SD (years): not reported for patients with GFR < 15 mL/min/1.73 m2 Sex (M/F): not reported for patients with GFR < 15 mL/min/1.73 m2 Dialysis vintage (years) (mean ± SD): not reported Comorbidities CVD: not reported for patients with GFR < 15 mL/min/1.73 m2 Diabetes: not reported for patients with GFR < 15 mL/min/1.73 m2 Hypertension: not reported for patients with GFR < 15 mL/min/1.73 m2 Depression (clinician diagnosis): not reported
Interventions	Intervention classification Non‐pharmacological intervention Indication: study targeting fatigue Intervention group Telephone‐adapted MBSR: an 8‐week program of meditation and yoga Control group Telephone‐based support group: psychosocial interventions Co‐interventions Not reported
Outcomes	Outcomes reported Fatigue outcome measures used: validation data available Anxiety STAI (Appendix 3): assessed at baseline, 2 and 6 months Depression CES‐D (Appendix 3): assessed at baseline, 2 and 6 months Sleep PSQI (Appendix 3): assessed at baseline, 2 and 6 months Sleep quality Sleep medications Daytime dysfunction Pain SF‐12v2 (Appendix 3): assessed at baseline, 2 and 6 months Physical Component Score Mental Component Score Fatigue PROMIS‐Fatigue Short Form v1.0 (Appendix 3): assessed at baseline, 2 and 6 months HRQoL SF‐12v2 (Appendix 3): assessed at baseline, 2 and 6 months Physical Component Score Mental Component Score Helpfulness of mindfulness practice to cope with stress: assessed at baseline, 2 and 6 months VAS Mindful state MAAS (15 items): assessed at baseline, 2 and 6 months Worry measured Penn State Worry Questionnaire (16 items): assessed at baseline, 2 and 6 months Stress Perceived Stress Scale (14 items): assessed at baseline, 2 and 6 months Kidney disease in daily life and the burden of kidney disease KDQOL‐SF: assessed at baseline, 2 and 6 months Impact Subscale (4 items): assessed at baseline, 2 and 6 months Burden Subscale (8 items): assessed at baseline, 2 and 6 months Salivary cortisol measurements Actigraphy: assessed at baseline, 2 and 6 months
Notes	Additional information Funding: National Institutes of Health (grant DK013083), National Institute of Diabetes and Digestive and Kidney Diseases Award P01 DK013083 and National Center for Advancing Translational Sciences of the National Institutes of Health Award Number UL1TR000114 Conflicts of interest/disclosures: none Trial registration identification number: NCT01254214 A priori published protocol was reported. The Journeys trial was approved by the University of Minnesota Institutional Review Board (IRB 0907S70361)
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote from Reilly‐Sponge 2015: "Randomisation schedules were computer‐generated using SAS, and designed using small randomly permuted blocks to promote balance within strata across treatment arms." Comment: Computer‐generated is considered as low risk of bias
Allocation concealment (selection bias)	Low risk	Quote from Reilly‐Sponge 2015: "The randomisation schedule was generated by the study statistician who was masked with respect to variables other than stratification variables." Comment: The statistician should ensure concealment and it was assessed as low risk of bias
Blinding of participants and personnel (performance bias) All outcomes	High risk	Quote from Gross 2017: "We conducted a randomised, active‐controlled, open‐label trial to test whether a Mindfulness‐based Stress Reduction (MBSR) program delivered in a novel workshop‐teleconference format would reduce symptoms and improve health‐related quality of life in patients awaiting kidney transplantation." Comment: An open‐label study is considered as high risk of bias
Blinding of outcome assessment (detection bias) All outcomes	High risk	Quote from Gross 2017: "Participants completed self‐report questionnaires at baseline, post‐intervention, and after 6‐months." Comment: The outcomes were assessed with an appropriate measure, without differences between groups. However, subjective measures were used, it was not stated whether outcomes were assessed without knowledge of treatment allocation, and knowledge of treatment assignment may have influenced reporting. Participant beliefs about the superiority/inferiority of either intervention could have influenced their assessment of the outcome, but there was no evidence that this was likely. However, objective and subjective outcomes were assessed
Incomplete outcome data (attrition bias) All outcomes	High risk	The number of patients who completed the study with GFR < 15 mL/min/1.73 m2 was not clearly stated. It was unclear if there was evidence that the results were not biased by missing outcome data
Selective reporting (reporting bias)	High risk	Information about the protocol and the statistical analysis plan were reported. It was not reported if multiple eligible outcome measurements (scales and time points) were pre‐specified. It was unclear if the reported approach to analysing this outcome was pre‐specified or influenced by the results. Fatigue at the end of treatment was reported in a format that was not extractable for meta‐analysis. All outcomes that should be addressed (fatigue, cardiovascular disease, and death) were not reported
Other bias	Low risk	There was no evidence of different baseline characteristics, or different non‐randomised co‐interventions between groups. Funding was unlikely to influence the data analysis and reporting and authors had no conflicts of interest