Gleeson 2012.
Study characteristics | ||
Methods | 16 weekly session trial with 2 arms
Duration of trial: 16 weekly sessions Country: Australia Setting: outpatient and inpatient. |
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Participants |
Method of recruitment of participants: participants identified by the research assistant in consultation with the outpatient case manager, using a checklist of the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM‐IV) for borderline personality disorder criteria
Diagnosis of borderline personality disorder: DSM‐IV
Means of assessment: Structured Clinical Interview for the DSM‐IV Axis I Disorders, Patient Edition (SCID‐I/P) and the antisocial and borderline personality disorder modules for Axis II disorders (SCID‐II)
Mean age: 18.4 years (standard deviation = 2.9)
Sex: 82% female Comorbidity: 12 participants had a diagnosis of borderline personality disorder (i.e. greater than or equal to 5 DSM‐IV criteria), and 4 cases had sub‐syndromal borderline personality disorder (4 DSM‐IV criteria) Inclusion criteria
Exclusion criteria
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Interventions |
Experimental group
Treatment name: HYPE + SFET
Number randomised to group: 8
Duration: 16 weekly sessions
Control/comparison group
Comparison name: SFET
Number randomised to group: 8
Duration: not stated Both groups Concomitant psychotherapy: not stated Concomitant pharmacotherapy: eligible for inclusion in study if had less than 6 months of previous treatment with antipsychotic medication Proportions of participants taking standing psychotropic medication during trial observation period: “patients taking medications. There were seven cases in the HYPE + SFET [87.5%] and five cases in the SFET [62.5%].” (Gleeson 2012, p. 26) Mean adherence did not differ sig. between groups (P = 0.983). (Tab. 2) |
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Outcomes |
Primary
Secondary
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Notes |
Sample size calculation: no
Ethics approval: no Comments from review authors:
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: “Randomization was coordinated by the statistician (SC) and was based on a computer‐generated number list.” (p. 23) |
Allocation concealment (selection bias) | High risk | Quote: “Outcome ratings were made by the study research assistant (RA) who was independent of the treatment, but not blind to treatment allocation because of limited resources for conducting the pilot study”. (p. 23) |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: “Outcome ratings were made by the study research assistant (RA) who was independent of the treatment, but not blind to treatment allocation because of limited resources for conducting the pilot study”. (p. 23) |
Incomplete outcome data (attrition bias) All outcomes | High risk | Comment: attrition rates: HYPE + SFET, number of participants = 4/8 and SFET, number of participants = 4/8. No reasons for attrition reported. 50% dropout rate. High risk of bias. No report of imputation method (e.g. ITT, as treated). Potential risk of bias. Summed up: High risk of bias |
Selective reporting (reporting bias) | High risk | Comment: no report of primary or secondary outcomes in the study (unlike the protocol) |
Other bias | Unclear risk |
Treatment adherence: Fidelity to CAT was managed by weekly group CAT supervision provided by two trained CAT supervisors (AC and LMc). (p. 23) Allegiance bias: Nothing found. Attention bias: No report of duration of the SFET group. |