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

Bellino 2007.

Study characteristics
Methods design: randomised controlled trial
Participants sex: 63.2% females ("The ratio of men to women was 7 to 19"; Bellino 2007, p. 720)
age: 30.55 years on average, SD = 5.75
location: Italy
setting: outpatient
exclusions: lifetime diagnosis of delirium, dementia, amnestic or other cognitive disorders, schizophrenia, 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 2 months prior to study, female patients of child‐bearing age not using adequate method of birth control
level of functioning/severity of illness: Mean baseline CGI‐S = 3.4, i.e. "mildly 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 (EG1): Fluoxetine + interpersonal therapy (IPT; 1 weekly session)
group 2 (EG2): Fluoxetine + cognitive therapy of therapy according of depression according to Beck (CT; 1 weekly session)
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, with 7 appointments, the first 2 fortnightly and the last 5 monthly; patients with additional current psychotropic treatment 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 (32 randomised, only 26 analysed since treated per protocol, N = 14 in the IPT and N = 12 in the CT group)
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk "Patients [...] were randomized using the web program Research Randomizer v3.0 (Urbaniak & Plous, Social Psychology Network, 2007)" (Bellino 2007, p. 720)
Allocation concealment (selection bias) Low risk Central allocation (Bellino 2010a [pers comm]).
Blinding of outcome assessment (detection bias)
All outcomes Low risk "A psychiatrist provided pharmacotherapy. He was blind to which type of psychotherapy the patients were receiving [...] The assessments were performed by an investigator who was blind to the treatment methods." (Bellino 2007, p. 720)
Selective reporting (reporting bias) Unclear risk No indication for selective reporting, but Insufficient information to permit judgement of 'Yes' or 'No'.
Treatment adherence? Low risk "Both psychotherapists received supervision during the treatment to assess their adherence to the psychotherapy manuals." (Bellino 2007, p. 720)
Allegiance effect improbable? Low risk The authors seem neither to be associated with neither IPT nor CT.
Attention bias: equal amounts of attention to all groups (obligatory treatment components)? Low risk Equal amounts of attention paid to both groups.