Philips 2018.

Study characteristics
Methods	15.5‐18 month trial with 2 arms Mentalisation‐based therapy (MBT) Treatment‐as‐usual (TAU) Duration of trial: 18 months Country: Sweden Setting: Stockholm Centre for Dependency Disorders
Participants	Method of recruitment of participants: “Patients were recruited through outpatient addiction treatment services throughout Stockholm County, through case‐finding among the social service offices in the region and through advertising in newspapers.” (quote, p 3) Sample size: 46 Diagnosis of borderline personality disorder: Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM‐IV) Means of assessment: Structured Clinical Interview for DSM‐IV Axis II Disorders (SCID‐II) Mean age: 36.7 years (standard devtiation = 9.6, range = 20‐54) Sex: 80.4% female Comorbidity: Current axis I disorders (overall sample, not specified by treatment groups): MDD 28.3%, other depressive disorder including dysthymia 28.3%, bipolar II disorder 6.5%,  PTSD 15.2%, any anxiety disorder excluding PTSD 65.2%, any eating disorder 6.5%, somatoform disorder 2.2%, any psychotic disorder 0% Current axis I substance use disorder (overall sample): alcohol 45.7%, amphetamines 13.0%, cannabis 6.5%, opioids 39.1%, sedatives, hypnotics, anxiolytics 21.7% Inclusion criteria DSM‐IV diagnosis of borderline personality disorder and substance dependence Males and females aged 18‐65 Currently under treatment at substance dependence treatment clinic Exclusion criteria Schizophrenia, schizoaffective disorder, bipolar disorder type I, cognitive impairment (including mild cognitive impairment: IQ below 85), autism spectrum disorders, psychopathy Participation in psychotherapy outside of the study (ongoing or terminated less than 90 days before inclusion) Not being able to communicate in the Swedish language without an interpreter
Interventions	Experimental group Treatment name: mentalisation‐based therapy (MBT) Number randomised to group: 24 Duration: mean = 15.5 months (mean = 63.3 sessions) Concomitant psychotherapy: not stated Concomitant pharmacotherapy: not stated Control/comparison group Comparison name: treatment‐as‐usual (TAU) Number randomised to group: 22 Duration: 18 months (mean = 10.7 therapy sessions) Concomitant psychotherapy: of the patients randomised to TAU (n = 22), 11 received some sort of psychotherapy Concomitant pharmacotherapy: not stated Proportions of participants taking standing psychotropic medication during trial observation period: unclear
Outcomes	Primary Borderline personality disorder severity, assessed by the Borderline Personality Disorder Severity Index, Fourth version (BPDSI‐IV) Self‐harm, assessed by the Deliberate Self‐harm Inventory (DSHI) Suicide‐related outcomes, by means of suicide attempts, assessed from direct contact with patients and health care staff and from reviewing case records Mental health status, assessed by the Global Symptom Index (GSI) Secondary Interpersonal problems, assessed by the Inventory of Interpersonal Problems ‐ Shortened Version (IIP) Attrition, in terms of patients lost after randomisation in each group
Notes	Sample size calculation: yes Ethics approval: Stockholm Regional Ethical Review Board (registration number: 2007/642‐31/1) Comments from review authors: none
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: “The randomization was conducted by the KTA [Karolinska Trial Alliance] using an urn procedure. The randomization was made in blocks and the researchers were not informed of the block size. KTA prepared sealed randomization envelopes with information about each patient’s treatment assignment.” (p 3)
Allocation concealment (selection bias)	Low risk	Quote: “The randomization was conducted by the KTA [Karolinska Trial Alliance] using an urn procedure. The randomization was made in blocks and the researchers were not informed of the block size. KTA prepared sealed randomization envelopes with information about each patient’s treatment assignment.” (p 3)
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Comment: no information on blinding provided by report authors
Incomplete outcome data (attrition bias) All outcomes	High risk	Quotes: “Outcome analyses were made both in the form of completer analyses and ITT analysis with the last observation carried forward. Throughout all measures, completer and ITT analyses gave equivalent results and therefore only the results from completer analyses are described here (Table 2). Outcome analyses of the self‐report and interview measures were seriously challenged by the high attrition rates, as only 24 out of 46 patients came to the measurements at endpoint 18 months (13 out of 24 patients in MBT, and 11 out of 22 patients in the control group).” (p 5) "Due to the recruitment problems in the project, our initial power calculation had to be revised." (p 4)
Selective reporting (reporting bias)	High risk	Comment: Beck’s Suicidal Intent Scale, Social Adjustment Scale – Self Report listed as secondary outcomes in trial registration, but not in final report. Outcomes related to health economics and criminality also listed in registration, but not in full report
Other bias	High risk	Adherence bias Quote: "Despite significant efforts to train therapists in the MBT model, most of the them had poor average results on the MDT adherence tests: only 2 therapists passed the threshold for adequate MBT, while the remaining 7 failed to do so." (p 6) Attention bias Quote: "For patients randomized to MBT (n = 24), the treatment duration was in average 15.5 months (SD 4.1, range 3–18) with a mean of 63.3 MBT sessions (SD 26.7, range 10–116). Control group patients received on average 10.7 therapy sessions (SD 14.7, range 0–45)". (p 5) Allegiance bias Comment: none found