Kramer 2011.
Study characteristics | ||
Methods | 10‐week trial with 2 arms
Duration of trial: 10 weeks Country: Switzerland Setting: outpatient clinic |
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Participants |
Method of recruitment of participants: not stated Sample size: 25 Diagnosis of borderline personality disorder: Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM‐IV) Means of assessment: Structured Clinical Interview for DSM‐IV Axis II Disorders (SCID‐II) Mean age: MOTR + TAU = 30.29 years (standard deviation = 12.43), TAU = 31.27 years (standard deviation = 8.21) Sex: 77% female Comorbidity: panic disorder, agoraphobia, alcohol abuse, major depression, bulimia, anorexia, somatoform disorder Inclusion criteria
Exclusion criteria
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Interventions |
Experimental group
Treatment name: MOTR + TAU
Number randomised to group: 11
Duration: 10 weeks
Concomitant psychotherapy: not stated
Concomitant pharmacotherapy: not stated Control/comparison group Comparison name: TAU Number randomised to group: 14 Duration: 10 weeks Concomitant psychotherapy: not stated Concomitant pharmacotherapy: If necessary, short‐term inpatient treatment was organised, as was adjunct pharmacotherapy 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: not stated
Ethics approval: The study was approved by the Ethics Committee of the Psychiatric Department involved. All patients gave written consent for the data to be used for research purposes. Comments from review authors: none |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Comment: randomisation was performed by blocks of 10 participants, using a computer‐based program |
Allocation concealment (selection bias) | Low risk | Comment: The preparation of sealed envelopes containing information on the condition for each participant was done by an independent researcher. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Comment: raters were unaware of the treatment condition. |
Incomplete outcome data (attrition bias) All outcomes | High risk | Comment: in case of missing values, LOCF used. The process analyses were carried out on a restricted sample of 20 patients (TAU = 10; MOTR +TAU = 10), due to missing values (related to early terminations) of 5 individuals having completed too few sessions to be taken into account. |
Selective reporting (reporting bias) | High risk | Comment: Borderline Symptoms List reported in the protocol did not appear in the publication. |
Other bias | High risk |
Allegiance bias Comment: Casper involved in the development of analysis plan Attention bias Comment: To counterbalance the increased time investment in condition 2, the therapists in condition 1 filled in a summary form on the patient’s symptoms and problems. |