Bedard 2013.

Methods	Multi‐centre randomised controlled trial, intervention and wait‐list control groups with cross‐over design.
Participants	Seventy‐six people who had sustained traumatic brain injury completed the study. Recruitment sources: community clinics, media advertisements, non‐government organisations and through personal contact with rehabilitation practitioners. Inclusion criteria: Evidence of depression (score of 16 or higher on the BDI‐II); ability to read and speak English; age 18 or over; and having completed all standard treatments for the injury. Exclusion criteria: Presence of unusual psychological processes such as psychosis, suicide ideation, substance abuse or major concurrent medical illnesses.
Interventions	For intervention participants, this was a 10‐week program of weekly 90‐minute group sessions plus recommended daily meditation for 20 to 30 minutes. The treatment followed a standard manual for mindfulness‐based cognitive therapy, however, components were modified to suit people with brain injury. After the intervention group had completed treatment, the wait list group was offered treatment, the outcomes of which are reported separately.
Outcomes	Primary outcome measures: Beck Depression Inventory ‐ second edition (BDI‐II) Patient Health Questionnaire (PHQ) Symptom Checklist 90 Revised (SCL‐90R) Secondary outcome measures: Philadelphia Mindfulness Scale Toronto Mindfulness Scale
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	High risk	Randomisation was conducted by a statistician who was independent of the clinicians and site investigators. The statistician used minimisation to ensure balance at baseline, between the groups, on a key outcome measure (Beck Depression Inventory). These measures present low risk of selection bias. However, five participants at one site were allocated to the intervention due to low participant numbers at that site.
Allocation concealment (selection bias)	Low risk	Allocation occurred off site and without the knowledge of the site investigators or group facilitators.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Blinding of participants and personnel not possible due to one intervention being an active intervention, while the other was a passive wait‐list control.
Blinding of outcome assessment (detection bias) All outcomes	High risk	The outcome measures were self‐report questionnaires and therefore, subject to high risk of bias due to the participants' knowledge to which intervention they had been allocated.
Incomplete outcome data (attrition bias) All outcomes	High risk	There was substantial dropout from the study (19 of 57 participants allocated to intervention and 10 of 48 allocated to wait‐list). The higher dropout from the intervention group could have increased bias as it is possible these participants had greater symptoms of depression, the primary outcome of the study.
Selective reporting (reporting bias)	Low risk	Outcome measures were stated in a study protocol registered on the Trialscentral.org website (NCT00745940). These outcomes were consistent with the published results.
Other bias	Unclear risk	‐