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 |
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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 |
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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) |
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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. |