Pascual 2015.
Study characteristics | ||
Methods | 16‐week trial with 2 arms
Duration of trial: 16 weeks Country: Spain Setting: outpatient |
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Participants |
Method of recruitment of participants: not stated
Sample size: 70 Diagnosis of borderline personality disorder: Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM‐IV‐TR) Means of assessment: Structured Clinical Interview for DSM‐IV Axis II Disorders (SCID‐II) and Revised Diagnostic Interview for Borderlines (DIB‐R) Mean age: CR = 32.4 years (standard deviation = 6.04), PE = 32.8 years (standard deviation = 8.8) Sex: 74.3% female Comorbidity: No information Inclusion criteria
Exclusion criteria
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Interventions |
Experimental group
Treatment name: cognitive rehabilitation (CR)
Number randomised to group: 36
Duration: 16 weeks Control/comparison group Comparison name: psychoeducation (PE) Number randomised to group: 34 Duration: 16 weeks Both groups Concomitant psychotherapy: no Concomitant pharmacotherapy: All patients continued pharmacological treatment if it had been initiated prior to inclusion. At baseline, 75% of the CR group was taking psychotropic medications, and 67.6% of the PE group. The difference was not significant. 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: yes 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 | Quote: “All participants were randomized to receive CR or PE in a 1:1 ratio stratified by centre, age, and education level. Generation of random allocation sequence was done with the Research Randomizer (www.randomizer.org)”. (p 2) |
Allocation concealment (selection bias) | Unclear risk | Comment: no clear information provided about whether or not allocation was concealed |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: “Study design was a multicenter, randomized, rater‐blind clinical trial”. (p 2) |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Comment: reasons for dropout fairly balanced between groups. No differences in overall attrition rates between groups, but the attrition rates exceeded the 30% estimate of the power calculation, which may have increased uncertainty in the overall effect estimates. |
Selective reporting (reporting bias) | Unclear risk | Comment: no secondary outcomes were included in the trial registration, but they were in the published paper. The paper did not categorise them as post hoc analyses. |
Other bias | High risk |
Treatment adherence Quote: "To ensure the reliability among centers regarding the evaluation and the treatment fidelity, two meetings were organized before the start of the study to train therapists". (p 2) Allegiance bias: Comment: Google search on first and last author did not reveal any allegiance biases. Attention bias: Comment: CR: group sessions, 120 minutes, twice a week during 16 weeks (32 sessions) PE: 16 weekly group sessions of 120 minutes each (16 sessions) |