Linehan 2006.

Study characteristics
Methods	12‐month trial with 2 arms Dialectical behaviour therapy (DBT) Non‐behavioural community treatment by experts (CTBE) Duration of trial: 12 months Country: USA Setting: outpatient
Participants	Method of recruitment of participants: not stated Sample size: 101 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) and International personality disorder examination (IPDE) Mean age: 29.3 years (standard deviation = 7.5) Sex: 100% female Comorbidity: Current psychiatric diagnoses (DSM‐IV): Major depressive disorder 72.3%, panic disorder 40.6%, PTSD 49.5%, any anxiety disorder 78.2%, any substance use disorder 29.7%, any eating disorder 23.8%, Cluster A PD 1.3%, Cluster B other than BPD 10.9%, Cluster C PD 25.7%. Prevalence rates did not differ significantly between the two treatment groups. Inclusion criteria: not stated Exclusion criteria Lifetime diagnosis of schizophrenia Schizoaffective disorder Bipolar disorder Psychotic disorder not otherwise specified Mental retardation Seizure disorder requiring medication Mandate to treatment Need for primary treatment for another debilitating condition
Interventions	Experimental group Treatment name: DBT Number randomised to group: 52 Duration: 12 months (weekly individual psychotherapy, group skills training, telephone consultation) Control/comparison group Comparison name: CTBE Number randomised to group: 49 Duration: 12 months Both groups Concomitant psychotherapy: no information given regarding further concomitant psychotherapy Concomitant pharmacotherapy: There were no differences in the types or amounts of psychotropic medication used at pretreatment. Proportions of participants taking standing psychotropic medication during trial observation period: exact proportions unclear. The use of psychotropic medications decreased significantly more in the DBT than the CTBE group during the treatment year.
Outcomes	Primary Suicidality, assessed with the Suicide Behaviors Questionnaire (SBQ) Secondary Depression, assessed with the Hamilton Depression Scale, 17 items (HAM‐D‐17)
Notes	Sample size calculation: yes 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	Quotes: "Using a computerized adaptive minimization randomization procedure, eligible subjects were matched to treatment condition on 5 primary prognostic variables: (1 and 2) the number of lifetime suicide attempts or nonsuicidal self‐injuries combined and psychiatric hospitalizations; (3) a history of only suicide attempts, only nonsuicidal self‐injury, or both; (4) age; and (5) a negative prognostic indicator of a Beck Depression Inventory score higher than 30 or a Global Assessment of Functioning score lower than 45 for a comorbid condition [...] Based on 0.8 power to detect significant differences between conditions (P = .05, 1‐sided), this procedure was used to randomize 101 subjects to DBT (n = 52) or to CTBE (n = 49)." ( p 758)." "The randomization program assigned clients to DBT and CTBE therapists, matching on sex, doctoral vs master's training, and years of clinical experience. Results indicated that therapists' sex and training did not differ in the 2 conditions. The CTBE therapists, however, had more clinical experience, which was expected because they were selected for their expertise." (p 760)
Allocation concealment (selection bias)	Low risk	Quote: "The participant coordinator, who was not blinded to treatment condition, executed the randomization program". (p 758) Comment: improbable that computerised assignment could be foreseen and thus bias be introduced
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Quote: "Assessments were conducted by blinded independent clinical assessors". (p 758)
Incomplete outcome data (attrition bias) All outcomes	Low risk	Comment: analyses were conducted on an ITT basis. 101 participants randomised, and 60 allocated to the EG and 51 to the CG arms. 8 DBT "training cases" and 2 CBT "pilot cases" excluded from analyses, but the remaining 52 EG and 49 CG participants were analysed regardless of discontinuation or getting lost to follow‐up.
Selective reporting (reporting bias)	Unclear risk	Comment: no clear indication of selective reporting, but there was insufficient information to permit a judgement of 'high' or 'low' risk of bias
Other bias	High risk	Performance bias Quote: "Psychotherapists recommended by colleagues as potentially good DBT therapists were recruited for the study; 8 had no previous DBT exposure and 8 had experience that ranged from workshop attendance to applied practice. [...] Training consisted of a 45‐hour DBT seminar followed by supervised practice. [...] Individual therapists were hired once 6 of 8 consecutive training case sessions were rated as adherent to DBT. During the study, adherence was assessed by coding a random selection of sessions on the DBT Global Rating Scale [...] which codes DBT adherence." (p 759) Allegiance bias Comment: the primary author (MLL) is developer of DBT Attention bias Comment: equal amounts of attention spent to both groups Vested interest Comment: first author is the developer of Dialectical Behavioural Therapy (DBT) – Source: linehaninstitute.org/about/organizations