Bianchini 2019.
Study characteristics | ||
Methods | 12‐month trial with 2 arms:
Duration of trial: 12 months Country: Italy Setting: hospital (forensic) |
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Participants |
Method of recruitment of participants: participants recruited from men consecutively detained as patients in three high intensity therapeutic facilities Sample size: 21 Diagnosis of borderline personality disorder: measured by the Personality Assessment Inventory (Morey 2007) Means of assessment: diagnosis confirmed in a clinical interview by a psychiatrist Mean age: 41.79 years (standard deviation = 8.14) Sex: 100% males Comorbidity: not stated Inclusion criteria
Exclusion criteria
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Interventions |
Experimental group Treatment name: DBT + treatment‐as‐usual Number randomised to group: 10 Duration: 12 months (once‐weekly individual therapy (60 minutes), once‐weekly group sessions (120 minutes)) Concomitant psychotherapy: treatment‐as‐usual included social skills, and cognitive remediation Concomitant pharmacotherapy: treatment‐as‐usual included pharmacotherapy Control/comparison group Comparison name: treatment‐as‐usual (pharmacotherapy, social skills, cognitive remediation) Number randomised to group: 11 Duration: 12 months Concomitant psychotherapy: not stated Concomitant pharmacotherapy: not stated |
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Outcomes |
Secondary
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Notes |
Sample size calculation: no Ethics approval: The study was approved by the Local Ethic Committee. Comments from review authors: none |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk |
Quote: “Each pair was randomised into either a group receiving 12 months of DBT along with other therapies available in the high security hospital (pharmacotherapy, social skills, and cognitive remediation) or a group receiving the other usual therapies alone” (pg. 124). No further details provided |
Allocation concealment (selection bias) | Unclear risk | Comment: the authors did not specify the process of allocation. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Comment: outcomes were self‐reported. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk |
Comment: Dropouts were not explicitly specified. However, the authors stated that “All participants completed at least 90% of the DBT sessions offered.” (p.127) Also “Once patients have been admitted […], they are required to complete any treatment programme offered; if a person does not, s/he may be referred back to the magistrate, who must consider if the individual is in breach of his/her order.” (p. 123) No details about the proportion of TAU completers, but, since all participants were convicted inpatients of a secure hospital, “completion” of TAU treatment was very likely. “All participants were reassessed after completion of the DBT programme or, for the control group, after the same time had elapsed”. (p.125) |
Selective reporting (reporting bias) | Unclear risk | Comment: no protocol was available. |
Other bias | High risk |
Adherence bias: therapeutic adherence not assessed Attention bias: DBT (once weekly individual plus group therapy) offered additionally to TAU, hence more attention spent to DBT group Allegiance bias: there was no indication of allegiance bias. |