Vitriol 2009.
Methods | RCT with 2 parallel conditions | |
Participants | Consecutive women, aged > 20 years, diagnosed with severe depression in primary care clinics were referred for evaluation. Participants meeting ICD‐10 criteria for severe depression, HAM‐D score > 20 and reporting past traumatic life experiences were included in the trial | |
Interventions | Intervention: participants were randomised to receive either standard treatment, described as supportive psychotherapy provided by a psychologist. The 3‐month brief psychodynamic intervention treatment was non‐manualised weekly psychotherapy focused on, "developing a cognitive understanding of personal characteristics and behaviours that allowed the repetition of traumatic experiences past and present. Behavioural changes that would alter the relationship between the victim and aggressor were addressed." An initial assessment session with a multidisciplinary team was described as using a psychodynamic orientation Control: standard treatment Participants in both groups received pharmacological treatment as appropriate |
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Outcomes | Outcome data was collected pre‐treatment, at 3 months (or on treatment completion) and at 6 months. An external rater administered the HAM‐D, and a different external rater administered the OQ‐45.2 and PTO | |
Notes | Subscale data from the OQ‐45 used in review for measurement of general psychiatric symptoms, interpersonal problems and social adjustment. HAM‐D ratings were used for depression and the PTO for a measure of anxiety symptoms | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Comment: insufficient information |
Allocation concealment (selection bias) | Unclear risk | Comment: insufficient information |
Blinding (performance bias and detection bias) All outcomes | Low risk | Comment: observer‐rated outcome ratings (HAM‐D) and participant self report ratings (OQ‐45, PTO) considered a low risk of detection bias |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: a similar level of attrition was present in the intervention group (9/45) compared with standard treatment (11/46) but there may have been differences in the reasons for drop‐out between groups: 4 in the intervention group "got better". However, outcome data were available for 91% of participants at 3 months and 81% at 6 months and ITT analyses were conducted thus minimising possible effects of missing data |
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 |