Bateman 2009.
| Study characteristics | ||
| Methods | design: randomised controlled trial | |
| Participants |
sex: 107/134 females (79.9%) age: eligible: 18‐65 years of age; mean age of participants allocated to outpatient mentalisation‐based treatment (MBT‐OP): 31.3 years, SD 7.6; mean age of participants allocated to structured clinical management (SCM): 30.9 years, SD 7.9 location: UK setting: outpatient exclusions: psychotic disorder, bipolar I disorder, opiate dependence requiring specialist treatment, mental impairment, evidence of organic brain disorder, being in long‐term psychotherapeutic treatment level of functioning/severity of illness: only subjects with "suicide attempt or episode of life‐threatening self‐harm within last 6 months" were eligible (Bateman 2009, p. 1356). mean GAF score at baseline: 41.0, i.e. participants had "serious symptoms OR any serious impairment in social, occupational, or school functioning" BPD diagnosis according to: DSM‐IV means of assessment: SCID‐II |
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| Interventions |
group 1 (EG): MBT‐OP; weekly individual and group psychotherapy group 2 (CG): SCM according to generic practice for borderline personality disorder offered by non‐specialist practitioners within U.K. psychiatric services; regular individual and group sessions with appointments every 3 months for psychiatric review duration: 18 months concomitant psychotherapy: patients already being in long‐term psychotherapeutic treatment were not eligible concomitant pharmacotherapy: patients were prescribed medication according to the APA guidelines; all patients were offered medication reviews every 3 months |
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| Outcomes |
outcomes considered in this review self‐rated: interpersonal problems (IIP), depression (BDI), general psychopathology (SCL‐90‐R‐GSI) observer‐rated: suicidal ideation (number of patients with suicide attempt during previous 6‐month period), self‐harming behaviour (number of patients with self‐harming behaviour during previous 6‐month period), mental health status (GAF) time‐points used here: 18 months (post‐treatment) |
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| Notes | analyses: intention‐to‐treat analysis based on treatment assignment | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "randomization using a stochastic minimization program (MINIM) balancing for age (blocked as 18‐25, 26‐30, >30 years), gender, and presence of antisocial personality disorder." (Bateman 2009, p. 1357) |
| Allocation concealment (selection bias) | Low risk | "Treatment allocation was made offsite [...] A study psychiatrist informed patients of their assignment." (Bateman 2009, p. 1357) |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | "Assessors were blind to treatment group." (Bateman 2009, p. 1358) |
| Selective reporting (reporting bias) | Low risk | Study protocol available (ISRCTN27660668). No indication for selective reporting. |
| Treatment adherence? | Low risk | "All sessions were audiotaped. Adherence to the MBT‐OP and SCM‐OP 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) |
| Allegiance effect improbable? | High risk | There is 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. |
| Attention bias: equal amounts of attention to all groups (obligatory treatment components)? | Low risk | Equal amounts of attention paid to both groups. |