Van den Bosch 2005.

Study characteristics
Methods	12‐month trial with two arms Dialectical behavior therapy (DBT) Treatment‐as‐usual (TAU) Duration of trial: 12 months Country: The Netherlands Setting: outpatient
Participants	Methods of recruitment of participants: recruited from mental health institutions (n = 39) and addiction treatment services (n = 19) Sample size: 58 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: 34.9 years (standard deviation = 7.7) Sex: 100% female Comorbidity: with or without substance use disorder Inclusion criteria Female Age 18–65 years DSM‐IV diagnosis of borderline personality disorder according to the SCID‐II with at least 6 diagnostic criteria of borderline personality disorder present Exclusion criteria Bipolar disorder (Chronic) psychotic disorder Severe cognitive impairments Insufficient command of the Dutch language
Interventions	Experimental group Treatment name: dialectical behavior therapy (DBT) Number randomised to group: 27 Duration: 12 months Control/comparison group Comparison name: treatment‐as‐usual Number randomised to group: 21 Duration: 12 months Both groups Concomitant psychotherapy: not stated Concomitant pharmacotherapy: no significant differences between the 2 groups with regard to medication use at baseline Proportions of participants taking standing psychotropic medication during trial observation period: "Medication use was monitored [...9. The greater improvement in the dialectical behaviour therapy group could not be explained by greater or other use of psychotropic medications by these patients. In both conditions, three‐quarters of the patients reported use of medication from one or more of the following categories: benzodiazepines, selective serotonin reuptake inhibitors (SSRIs), tricyclic antidepressants, mood stabilisers and neuroleptics. Use of SSRIs was reported by 14 (52%) of the dialectical behaviour therapy patients and 19 (61%) of treatment‐as‐usual patients (χ2=0.44; P=0.509). These findings eliminate the possibility of confounding by medication use". (Verheul 2003, p 137)
Outcomes	Primary: Parasuicidal behaviour, assessed by Lifetime Parasuicide Count (LPC) self‐mutilative acts during previous 3‐month period Secondary: Impulsivity, assessed by the Borderline Personality Disorder Severity Index‐IV (BPDSI‐IV‐ impulsivity)
Notes	Sample size calculation: not stated Ethics approval: not stated Comments from review authors: none
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "...patients were randomly assigned to treatment conditions. A minimisation method was used to ensure comparability of the two treatment conditions on age, alcohol problems, drug problems and social problems (as measured by the European version of the Addiction Severity Index [...]". (Verheul 2003, p 135)
Allocation concealment (selection bias)	Unclear risk	Comment: no further details
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Quote: "although the research assessors were not informed about the treatment condition of their interviewees, it is unlikely that they remained 'masked' throughout the project. Patients might have given them this information, or it could easily have been derived from some of the interviews." (Verheul 2003, p 139)
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Comment: no further details
Selective reporting (reporting bias)	Unclear risk	Comment: no indication of selective reporting, but Insufficient information to permit judgement of 'high' or 'low' risk of bias
Other bias	Unclear risk	Comment: no further details