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. 2012 Aug 15;2012(8):CD005652. doi: 10.1002/14651858.CD005652.pub2

Bellino 2006.

Study characteristics
Methods design: randomised controlled trial
Participants sex: 60% females ("The ratio of men to women was 3 to 5."; Bellino 2006, p. 455
age: 26.4 years on average, SD = 3.7
location: Italy
setting: outpatient
exclusions: lifetime diagnosis of delirium, dementia, amnestic or other cognitive disorders, schizophrenia or other psychotic disorders, patients whose major depressive episode was an expression of bipolar disorder; current diagnosis of substance abuse disorder, treatment with psychotropic drugs or psychotherapy during the 2 months prior to the study, female patients not using an adequate method of birth control
level of functioning/severity of illness: mean baseline CGI‐S = 4.35, i.e. "moderately ill".
BPD diagnosis according to: DSM‐IV‐TR, comorbid diagnosis of mild to moderate major depressive episode required for inclusion
means of assessment: SCID
Interventions group 1 (EG): Fluoxetine + interpersonal therapy (IPT; 1 weekly session)
group 2 (CG): Fluoxetine + clinical management (CM; 6 appointments, first two fortnightly, monthly afterwards)
duration: 24 weeks
concomitant psychotherapy: patients having received psychotherapy during the 2 months prior to the study were not eligible
concomitant pharmacotherapy: all study participants received 20 to 40 mg fluoxetine daily; patients with psychotropic treatment during the 2 months prior to the study were not eligible for inclusion
Outcomes outcomes considered in this review
self‐rated: anxiety (HARS)
observer‐rated: depression (Ham‐D), mental health status (CGI‐S)
time‐points used here: week 24 (post‐treatment)
Notes analyses: per protocol (39 randomised, only 32 analysed since treated per protocol, N = 16 per group)
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Use of a computer random number generator (Bellino 2010a [pers comm]).
Allocation concealment (selection bias) Low risk Central allocation (Bellino 2010a [pers comm]).
Blinding of outcome assessment (detection bias)
All outcomes Low risk "assessments were performed by an investigator who was blind to the treatment methods" (Bellino 2006, p. 455);
Selective reporting (reporting bias) Unclear risk No indication for selective reporting, but Insufficient information to permit judgement of 'Yes' or 'No'.
Treatment adherence? High risk "psychotherapist [...] had 5 years of experience practising IPT" (Bellino 2006, p. 455)
no specific measures to monitor treatment adherence (Bellino 2010a [pers comm])
Allegiance effect improbable? Low risk The authors seem not to be associated with IPT.
Attention bias: equal amounts of attention to all groups (obligatory treatment components)? High risk More attention paid to EG participants.