Jørgensen 2013.

Study characteristics
Methods	18‐24 month trial with 2 arms Combined mentalisation based therapy (MBT) Supportive group treatment Duration of trial: 18‐24 months Country: Denmark Setting: outpatient
Participants	Method of recruitment of participants: referred from outpatient clinics, community psychiatric wards, and psychiatrists in private practice Sample size: 111 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‐III) Mean age: MBT = 29.2 years (standard deviation = 6.1), supportive group = 29 years (standard deviation = 6.4) Sex: 95‐96% female Comorbidity: In the group of patients allocated to mentalisation based therapy (MBT) treatment, 53 (72%) met diagnostic criteria for depression (9 in remission at the time of assessment), 27 (37%) met criteria for anxiety disorder, 14 (19%) met criteria for an obsessive–compulsive disorder and 36 (49%) for a (previous or current) eating disorder. On Axis II, 48 (65%) met criteria for at least 1 personality disorder other than borderline and 16 (22%) for avoidant personality disorder. In the supportive therapy group, 28 (76%) met criteria for depression (11 of these were in remission at assessment), 9 (24%) met criteria for anxiety disorder, 5 (14%) for an obsessive–compulsive disorder and 14 (38%) for a (past or current) eating disorder. 32 (86%) met criteria for at least 1 other personality disorder, 10 (27%) for avoidant personality disorder Inclusion criteria DSM‐IV BPD age 21 years or over GAF score above 34 Exclusion criteria Diagnosis of antisocial or paranoid personality disorder at time of assessment Severe substance abuse Younger than 21 years
Interventions	Experimental group Treatment name: combined mentalisation‐based therapy (MBT) Number randomised to group: 74 Duration: 18‐24 months Control/comparison group Comparison name: supportive group treatment Number randomised to group: 37 Duration: 18‐20 months Both groups Concomitant psychotherapy: yes, psychoeducational programme once a month for 6 months Concomitant pharmacotherapy: all participants were offered medical treatment in accordance with American Psychological Association recommendations Proportions of participants taking standing psychotropic medication during trial observation period: “…34% of patients in combined treatment and 48% of patients in supportive therapy had their medication significantly reduced or withdrawn while in treatment (difference NS, P = 0.24). Only 16% in combined and 7% in supportive therapy had their medical treatment intensified during the course of treatment (difference NS, P = 0.49).“ (p. 312)
Outcomes	Primary BPD severity, assessed by the Structured Clinical Interview for DSM‐IV Axis II Disorders (SCID‐II) Psychosocial functioning, assessed by the Global Assessment of Functioning Scale (GAF) Secondary Interpersonal problems, assessed by the Inventory of Interpersonal Problems (IIP) Depression, assessed by the Beck Depression Inventory (BDI) Attrition
Notes	Sample size calculation: yes Ethics approval: yes Comments from review authors: All clinically and statistically significant changes with regard to all symptoms were sustained at follow‐up in all outcome measures – no positive or negative changes at follow‐up were observed.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: “Two‐thirds (n = 74) of the 111 patients included in the study were randomized to combined treatment, while one‐third (n = 37) were offered supportive group therapy”. “The skewed randomization of patients (…), which was dictated partly by a desire on the part of the clinic’s management to offer intensive treatment to as many borderline patients as possible, and partly by available treatment resources, reduced statistical power”. (p. 307)
Allocation concealment (selection bias)	Unclear risk	Quote: “Randomization was conducted by individuals outside the clinic.” "Group allocation was not concealed". (Jørgensen 2013) [pers comm]
Blinding of outcome assessment (detection bias) All outcomes	High risk	Quote: “(…)GAF score was then assessed by team consensus. The team was not blind to treatment group when making these ratings as most patients were known by the team.” (p. 309)
Incomplete outcome data (attrition bias) All outcomes	High risk	Quote: “Statistical power was further reduced by the relatively high attrition rate (…) owing to some patients’ refusal to complete all assessments at the assigned time points.” “Attrition from the study is relatively high (approximately 43% of included patients with intention to treat, 26% of patients starting treatment)”. “The level of attrition from the two groups was not significantly different (Fisher’s exact test, P = .79).” (p. 315)
Selective reporting (reporting bias)	Unclear risk	Comment: there was no study protocol available to compare with the report.
Other bias	High risk	Adherence bias: "the two compared treatments were not based on detailed treatment manuals and our design did not include ongoing systematic monitoring of the two treatment modalities (adherence and competence ratings)”. (p 315) Attention bias: The combined treatment consisted of 45‐min sessions of individual psychotherapy carried out weekly over an 18‐month period and 1½‐h weekly sessions of group psychotherapy over 18–20 months (starting approximately 3 months after the individual therapy). Supportive treatment consisted of one and a half hours of supportive group therapy every fortnight. Allegiance bias: no allegiance found