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

Bateman 1999.

Study characteristics
Methods Randomised controlled trial with 2 arms for 18 months
  1. Partial hospitalised group receiving mentalisation‐based therapy

  2. Standard psychiatric care


Duration of trial: up to 18 months
Country: UK
Setting: partially hospitalised/outpatient
Participants Method of recruitment: Patients referred
Overall sample size: 38
Diagnosis of borderline personality disorder: Diagnostic and Statistical Manual of Mental Disorders, 3rd revision (DSM‐III‐R)
Means of assessment: both Structured Clinical Interview for DSM‐IV personality disorders (SCID) and Revised Diagnostic Interview for Borderlines (DIB‐R)
Mean age: 31.8 years
Sex: 57.9% female
Comorbidity: In terms of axis I diagnosis, 70% and 62% had major depression in the intervention and control group, respectively.
Inclusion criteria:
  1. Patients diagnosed with borderline personality disorder


Exclusion criteria
  1. Schizophrenia

  2. Bipolar disorder

  3. Substance misuse

  4. Mental impairment

  5. Evidence of organic brain disorder

Interventions Experimental group
Treatment name: mentalisation‐based treatment (MBT)
Number randomised to group: 19
Duration: up to 18 months
Control/comparison group
Comparison name: standard treatment in the general psychiatric services
Number randomised to group: 19
Duration: up to 18 months
Both groups
Concomitant psychotherapy: none
Concomitant pharmacotherapy: antidepressant and antipsychotic drugs prescribed, as appropriate, polypharmacy was discouraged
Proportions of participants taking standing medication during trial observation period:
"The initial types and doses of medication were the same for both groups." (Bateman 1999, p. 1565)
Exact medication use during treatment unclear: higher medication costs in control group (z‐3.9, P < 0.001) (Bateman 2003, Tab. 1, p. 170) indicates more frequent use of medications in the control group.
Outcomes Primary
  1. Number of patients with self‐harming behaviour in the last 6‐month period

  2. Number of patients with suicide attempts in the last 6‐month period


Both outcomes assessed with the Suicide and Self‐Harm Inventory, a semi‐structured interview.
Secondary
  1. Interpersonal problems, assessed with the Inventory of Interpersonal Problems

  2. Depression, assessed with the Beck Depression Inventory

Notes Sample size calculation: not stated
Ethics approval: not stated
Comments from review authors:
  1. Per protocol (22 randomised to each group, only 19 per group analysed since treated per protocol)

  2. Information about randomisation and allocation procedure, as well as blinding, was received by email from Dr Bateman.

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Comments: Did not use a minimisation method. This method is used to minimise the imbalance between the number of patients in each treatment group. This method maintains a better balance than traditional blocked randomisation, and its advantage increases with the number of stratification factors. It is reported that random assignment was used but it is unclear how the random assignment was performed.
Allocation concealment (selection bias) Low risk Comment: Allocation was completed centrally at the university.
Blinding of outcome assessment (detection bias)
All outcomes Low risk Comment: Outcome assessors were blind to intervention group.
Incomplete outcome data (attrition bias)
All outcomes High risk Comment: Analyses were based on completers only.
Selective reporting (reporting bias) Unclear risk Comment: There was no clear indication of selective reporting, but there was insufficient information to permit judgement of 'high' or 'low'.
Other bias High risk Attention bias: more attention paid to experimental group participants
Allegiance bias: there was no indication given for an allegiance effect. However, as both authors are the founders of MBT, the treatment actually used in the experimental group, an allegiance effect seems not improbable.
Adherence bias: "All sessions were audiotaped. Adherence to the treatment manuals was determined by randomly selected audiotapes of individual and group sessions drawn from two distinct 6‐months periods of each case using a modified version of the recommended adherence rating scale." (Bateman 2009, online data supplement, p 1)