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. 2020 May 4;2020(5):CD012955. doi: 10.1002/14651858.CD012955.pub2

Bianchini 2019.

Study characteristics
Methods 12‐month trial with 2 arms:
  1. Standard dialectical behavior therapy (DBT) + treatment‐as‐usual (TAU) within the forensic hospital


Duration of trial: 12 months
Country: Italy
Setting: hospital (forensic)
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
  1. Criteria for borderline personality disorder

  2. History of violence


Exclusion criteria
  1. Cognitive deficit (intelligence quotient (IQ) < 70)

  2. Comorbid neurological diseases

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
Outcomes Secondary
  1. Affective instability, assessed by the Difficulties in Emotion Regulation Scale, total score

  2. Impulsivity, assessed by the Barrett Impulsiveness Scale, total score

Notes Sample size calculation: no
Ethics approval: The study was approved by the Local Ethic Committee.
Comments from review authors: none
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.