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 |
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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 |
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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 (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. |