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. 2020 May 4;2020(5):CD012955. doi: 10.1002/14651858.CD012955.pub2

Pascual 2015.

Study characteristics
Methods 16‐week trial with 2 arms
  1. Cognitive rehabilitation (CR)

  2. Psychoeducation (PE)


Duration of trial: 16 weeks
Country: Spain
Setting: outpatient
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
  1. Outpatients aged 18‐45 years

  2. Diagnoses of borderline personality disorder according to DSM‐IV‐TR criteria and evaluated by 2 semi‐structured clinical interviews ‐ SCID‐II and the DIB‐R ‐ to guarantee a correct diagnosis

  3. Clinical severity measured with Clinical Global Impression for BPD (CGI‐ BPD) higher than 4

  4. Functional impairment measured with a Global Assessment Functioning (GAF) lower than 65


Exclusion criteria
  1. Severe physical conditions, such as organic brain syndrome or neurological disease that could affect neuropsychological performance

  2. Intelligence quotient below 85

  3. Major depression disorder (MDD) or substance misuse within the last 6 months evaluated with DSM‐IV‐TR criteria and SCID‐I specific sections

  4. DSM‐IV‐TR criteria for schizophrenia, severe psychotic disorder or bipolar disorder evaluated by SCID‐I specific sections

  5. Previous participation in any psychoeducation or cognitive rehabilitation intervention

Interventions Experimental groupTreatment name: cognitive rehabilitation (CR)
Number randomised to group: 36
Duration: 16 weeks
Control/comparison groupComparison name: psychoeducation (PE)
Number randomised to group: 34
Duration: 16 weeks
Both groupsConcomitant 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
Outcomes Primary
  1. BPD severity, assessed by Borderline Symptom List – 23 (BSL‐23)


Secondary
  1. Impulsivity, assessed by the Barrett Impulsiveness Scale (BIS)

  2. Depression, assessed bythe Beck Depression Inventory (BDI) or the Montgomery Åsberg Depression Rating Scale

  3. Attrition, in terms of patients lost after randomisation in each group

  4. Adverse events (final results not reported)

Notes Sample size calculation: yes
Ethics approval: yes
Comments from review authors: none
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)