Carter 2010.
Study characteristics | ||
Methods | Parallel‐arm, randomised controlled trial with 2 treatment arms
Duration of trial: 6 months (all participants were offered 12 months of DBT, but the comparison between groups was restricted to the first 6 months of DBT vs TAU + WL). Country: Australia Setting: outpatient |
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Participants |
Methods of recruitment of participants: Participants were referred from treating general practitioners, treating psychiatrists or public mental health services (any units of Hunter Mental Health Services). Sample size: 73 Diagnosis of borderline personality disorder: Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM‐IV) Means of assessment: clinical interview, ICD‐10 International Personality Disorder Examination (IPDE) Mean age: 42.5 years (standard deviation = 6.1) Sex: 100% female Comorbidity: participants showed substantial psychopathology with high rates of BPD criteria, International Personality Disorder Examination (IPDE) scores and Axis 1 comorbidity. Inclusion criteria: not stated Exclusion criteria
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Interventions |
Experimental group Treatment name: DBT Number randomised to group: 38 Duration: 6 months (weekly individual therapy, weekly group‐based skills training, telephone access to an individual therapist, therapist supervision) Control/comparison group Comparison name: TAU + waiting list Number randomised to group: 35 Duration: 6 months (participants were offered DBT treatment after a 6‐month waiting period) Both groups Concomitant psychotherapy: participants were asked to discontinue psychological therapy of any sort for at least the 12‐month duration of dialectical behavior therapy (DBT) Concomitant pharmacotherapy: not specified Proportions of participants taking standing psychotropic medication during trial observation period: unclear |
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Outcomes |
Primary
Secondary
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Notes |
Sample size calculation: yes Ethics approval: not stated Comments from review authors:
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Comment: the authors used a computerised random number generator to generate allocations ‐ placed into sealed opaque envelopes (in blocks of 8). Envelope drawn after baseline assessments complete". (Carter 2010 [pers comm]) |
Allocation concealment (selection bias) | Low risk | Quote: "Randomization was carried out by the research staff. [...] participants were allocated by selecton of sealed opaque envelopes." (p. 164) |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "Outcomes were determined [...] by assessors blinded to allocation. [...] All reasonable attempts were made to maintain blindness to allocation status for these raters, but this could not achieve perfect blindness." (pp. 164) |
Incomplete outcome data (attrition bias) All outcomes | High risk | Comment: the authors conducted per protocol analyses (DBT group: 20 completers of treatment and self‐reports out of 38 allocated to this group; TAU group: 31 completers of waiting list and self‐reports out of 35 allocated) |
Selective reporting (reporting bias) | Unclear risk | Comment: there was no indication for selective reporting, but Insufficient information to permit judgement of 'high' or 'low'. |
Other bias | High risk |
Performance bias: "The intervention condition was based on the comprehensive DBT model, a team‐based approach including [...] therapist supervision groups." (p. 163). "[...] possible inferiority of training of DBT therapists to that of those in other studies or inferior adherence to the DBT methods despite adequate training" (p. 170). There was no mention of any objective means of assessment. Allegiance bias: no indication of allegiance bias Attention bias: more attention paid to DBT group participants |