Carter 2010.

Study characteristics
Methods	design: parallel‐arm, randomised controlled trial
Participants	sex: 73/73 females (100%) age: mean age 42.5 years, SD = 6.1; eligible: 18‐65 years of age location: Australia setting: outpatient exclusions: schizophrenia, bipolar affective disorder, psychotic depression, florid antisocial behaviour, developmental disability, disabling organic condition; "The psychiatrist assessor had the option of determining if any potential subjects were unsuitable for inclusion in therapy or unmotivated to participate, although there were no specific criteria for this exclusion." (Carter 2010, p. 164) level of functioning/severity of illness: all participants had a history of at least three self‐reported self‐harm episodes in the preceding 12 months BPD diagnosis according to: DSM‐IV means of assessment: clinical interview, IPDE‐Q
Interventions	group 1 (EG): DBT (weekly individual therapy, weekly group‐based skills training, telephone access to an individual therapist, therapist supervision) modified insofar that telephone access was delivered using a group roster of DBT individual therapists in the daytime, but not contact with each participants's individual therapist, and the local psychiatric hospital at night; skills training groups dealt with all usual modules except of mindfulness group 2 (CG): TAU + Waiting List: participants were offered DBT treatment after a 6 month waiting period duration: 6 months (all participants were offered 12 months of DBT treatment, but the comparison between groups was restricted to the first 6 months of DBT vs. TAU+WL) concomitant psychotherapy: participants were asked to discontinue psychological therapy of any sort for at least the 12 month duration of DBT concomitant pharmacotherapy: not specified;
Outcomes	outcomes considered in this review self‐rated: interpersonal problems (WHOQOL‐BREF‐social relationships), mental health status (Brief Disability Questionnaire ‐ days out of role) observer‐rated: number of patients with self‐harming behaviour time‐points used here: 6 months
Notes	analyses: per protocol (DBT group: 20 completers of treatment and self‐reports out of 38 allocated to this group; TAU group: 31 completers of waitlist and self‐reports out of 35 allocated)
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	We used a computerised random number generator to generate allocations ‐ placed into sealed opaque envelopes (in blocks of 8). Envelope drawn after baseline assessments complete. (Carter 2010a [pers comm])
Allocation concealment (selection bias)	Low risk	"Randomization was carried out by the research staff. [...] participants were allocated by selecton of sealed opaque envelopes." (Carter 2010, p. 164)
Blinding of outcome assessment (detection bias) All outcomes	Low risk	"Outcomes were determined [...] by assessors blinded to allocation. [...] All reasonable attempts were made to maintain blindness to allocation status for these raters, but this could not achieve perfect blindness." (Carter 2010, pp. 164 et seq.)
Selective reporting (reporting bias)	Unclear risk	No indication for selective reporting, but Insufficient information to permit judgement of 'Yes' or 'No'.
Treatment adherence?	Unclear risk	"The intervention condition was based on the comprehensive DBT model, a team‐based approach including [...] therapist supervision groups." (Carter 2010, p. 163 et seq.) "[...] possible inferiority of training of DBT therapists to that of those in other studies or inferior adherence to the DBT methods despite adequate training" (Carter 2010, p. 170) No mention of any objective means of assessment.
Allegiance effect improbable?	Low risk	No indication of an allegiance effect.
Attention bias: equal amounts of attention to all groups (obligatory treatment components)?	High risk	More attention paid to EG participants.