Kramer 2014.
Study characteristics | ||
Methods | 10‐session trial with 2 arms (endpoint data):
Duration of trial: 10 sessions Country: Switzerland Setting: Outpatient |
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Participants |
Method of recruitment of participants: not stated
Sample size: 85 Diagnosis of borderline personality disorder: Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM‐IV) Means of assessment: DSM‐IV diagnoses of borderline personality disorder were established by trained clinicians or clinician researchers for all patients using the Structured Clinical Interview (SCID‐II) for DSM‐IV Mean age: GPM = 30.95 years (standard deviation = 11). MOTR = 34.64 years (standard deviation = 9.97) Sex: 68.2% female Comorbidity: current DSM‐IV diagnoses; depressive disorder = 56/74, anxiety disorder = 13/74, eating disorder = 10/74, substance abuse = 54/74, intelligence limitation = 6/74, sexual disorder = 9/74, attention disorder = 4/74. Axis II cluster A = 11/74, Axis II cluster B = 23/74, Axis II cluster C = 12/74 Inclusion criteria
Exclusion criteria
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Interventions |
Experimental group
Treatment name: GPM
Number randomised to group: 43; analysis on 38 only
Duration: 10 sessions; no further information
Concomitant psychotherapy: not stated
Concomitant pharmacotherapy: 23/38 (61%) Control/comparison group Comparison name: MOTR Number randomised to group: 42; analysis on 36 only Duration:10 sessions; no further information Concomitant psychotherapy: not stated Concomitant pharmacotherapy: medication use at baseline: MOTR group 23/38 (61%), TAU group 21/36 (58%); χ2=.04, P = 0.84 Proportions of participants taking standing psychotropic medication during trial observation period: unclear |
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Outcomes |
Primary
Secondary
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Notes |
Sample size calculation: yes Ethics approval: The research protocol was approved by the local ethics board (clearance number 254/08), as well as the research committee of the university department. Comments from review authors:
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Comment: randomisation was performed using an internet‐based block randomisation program; sealed envelopes were prepared by an independent researcher and opened when the patient accepted the study (p 179). |
Allocation concealment (selection bias) | Low risk | Comment: sealed envelopes were prepared by an independent researcher and opened when the patient accepted the study (p 179). |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Comment: no information regarding blinding of outcome assessors |
Incomplete outcome data (attrition bias) All outcomes | High risk | Comment: 11 participants dropped out before session two. No reasons provided. No reasons provided either for the 14 who discontinued the treatment. No demographic data on the entire sample (number of participants = 85). Imputation method used = LOCF |
Selective reporting (reporting bias) | High risk | Comment: Working Alliance Inventory – Short Form, a self‐report questionnaire was presented in the full report but there was no mention of this outcome in protocol. |
Other bias | High risk |
Treatment adherence Comment: adherence was assessed at the end of each of the 40 treatments (see p 180). Attention bias Comment: nothing found Allegiance bias Ueli Kramer, Franz Caspar & Martin Drapeau are all heavily linked to MOTR. Vested interest Comment: nothing found |