Linehan 2015a.
Study characteristics | ||
Methods | 49‐week trial with 3 arms
Duration of trial: 49 weeks Country: USA Setting: university clinic and community setting |
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Participants |
Method of recruitment of participants: outreach to healthcare practitioners Sample size: 99 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: 30.3 years (range = 18‐60) Sex: 100% female Comorbidity: not stated Inclusion criteria
Exclusion criteria
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Interventions |
Experimental group
Treatment name: DBT
Number randomised to group: 33
Duration: 52 weeks Control/comparison group 1 Comparison name: DBT‐I Number randomised to group: 33 Duration: 49 weeks Control/comparison group 2 Comparison name: DBT‐S Number randomised to group: 33 Duration: 50 weeks All groups: Concomitant psychotherapy: not stated Concomitant pharmacotherapy: psychotropic medication allowed Proportions of participants taking standing psychotropic medication during trial observation period: exact proportions unclear, but no between‐group differences in use of psychotropic medications |
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Outcomes |
Primary
Secondary
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Notes |
Sample calculation: yes
Ethics approval: yes Comments from review authors: none |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: “A computerized adaptive randomization procedure (5) matched participants on age, number of suicide attempts, number of NSSI episodes, psychiatric hospitalizations in the past year, and depression severity”. (p 476) |
Allocation concealment (selection bias) | Unclear risk | Quote: “The participant coordinator, who was not blinded to the treatment condition, executed the randomization and collected treatment‐related data”. (p 476) |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: “Assessments were conducted before treatment and quarterly during 1 year of treatment and 1 year of follow‐up by blinded independent assessors trained by instrument developers or approved trainers (including K.A.C. and A.M.M.‐G.) and evaluated as reliable for each instrument.” (p 476) |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Comment: no information on ITT, but all randomised participants were included in analysis, so ITT was likely used. No imputation methods seem to have been used. 26/99 randomised were lost at follow‐up. No differences in rate of dropouts between arms, no evidence that group differences in missing data biased major outcome variables |
Selective reporting (reporting bias) | High risk | Comment: protocol lists 'coping skills' as a secondary outcome. It was not included in study. 'Reasons for living' and depression and anxiety outcome measures were included in the paper. These were not listed in the protocol. Neither were they mentioned in the paper as post hoc analyses |
Other bias | High risk |
Treatment adherence Comment: treatment adherence differed significantly between 2 out of 3 groups Adherence bias Comment: first author is the developer of Dialectical Behavioural Therapy (DBT), see http://www.linehaninstitute.org/ab out‐Linehan.php Attention bias Quote: “Participants in standard DBT received significantly more individual sessions than those in DBT‐S owing to weekly sessions in standard DBT and as‐needed sessions in DBT‐S. Participants in standard DBT and DBT‐S received more group therapy sessions than those in DBT‐I owing to the optional nature of group therapy in DBT‐I. Participants in standard DBT attended more groups than those in DBT‐S owing to trend‐level differences in treatment retention.” (p 477) |