Bressi 2010.
Methods | Single‐centre RCT, 1‐year study, parallel design | |
Participants | 30 participants were each randomised to receive STPP or TAU Inclusion criteria: 18‐60 years old with a main diagnosis of an anxiety disorder or depressive disorder; participants were not to have been on psychotropic medication for a period of at least 2 weeks (4 weeks for monoamine oxidase inhibitors). Exclusion criteria: mental retardation; history of organic mental disorders, schizophrenia, bipolar disorders or substance use; severe axis II personality disorder; currently undergoing treatment. An independent interview confirmed DSM IV ‐ TR diagnoses using the SCID |
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Interventions | Intervention: STPP derived from Malan 1976 and Malan 1992 based on a 40‐session treatment plan. Therapists were 4 psychiatrists with experience (12.3 mean years) in STPP. Therapists received weekly individual and group supervision and were given verbatim transcripts of sessions. Adherence was rated and additional supervision provided when STPP techniques were not being applied. Treatment sessions were audio‐recorded. Concomitant psychotropic medication was only allowed for the first 3 weeks of the study Control: TAU consisted of routine psychiatric treatment: drug treatment (selective serotonin reuptake inhibitors/serotonin noradrenaline (norepinephrine) reuptake inhibitors) and ongoing clinical interviews with a minimum of 1 session per month of and a maximum of 4 sessions a month for 40 weeks. Interviews monitored drug treatment (compliance, side effects, dose adjustment) and general clinical state |
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Outcomes | Primary outcome measures included the Clinical Global Impression Scale, the SCL‐90‐R, and the SCL‐90‐GSI. The IIP was included as a measure of interpersonal functioning. Measures were completed at recruitment and 12‐months post admission | |
Notes | IIP, SCL‐90‐GSI, anxiety and depression subscales used in analyses | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "block randomization...then randomly allocated using computer generated random number" Comment: selection bias unlikely |
Allocation concealment (selection bias) | Unclear risk | Quote: "block randomization...then randomly allocated using computer generated random number" Comment: no further details; therefore, insufficient information to conclude on concealment |
Blinding (performance bias and detection bias) All outcomes | Low risk | Comment: self report data (IIP, SCL‐90‐GSI and anxiety and depression subscales) considered low risk of detection bias |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "intention‐to‐treat analysis was performed...observation carried forward for participants who did not complete the trial" Comment: ITT controlled for incomplete data. 80% completed the trial, with equal non‐completers across groups |
Selective reporting (reporting bias) | Unclear risk | Comment: insufficient information to permit judgement. No published report on pre‐specified outcomes |
Other bias | Unclear risk | Comment: insufficient information to permit judgement |