Cooper 2003.
| Methods | Single‐centre RCT | |
| Participants | Large consecutive series of 3222 primiparous women identified through birth records of Addenbrooke's Hospital, Cambridge, UK, screened between January 1990 and August 1992 for mood disturbance in the early post‐partum period, using postal administration of EPDS. EPDS score of ≥ 12 assessed; women with PPD invited to take part Inclusion criteria: 15‐mile radius to hospital, English as first language Exclusion: delivered prematurely, if infant had any gross congenital abnormality, if they did not have a singleton birth or were intending to move out of the area during the study period 206 women identified; 193 agreed to take part |
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| Interventions | Women assigned to 1 of 4 conditions Intervention 1: CBT Intervention 2: psychodynamic therapy (as described by Cramer 1990; Stern 1995) Intervention 3: non‐directive counselling Control: "routine primary care" Therapy was conducted in women's homes on a weekly basis from 8 to 18 weeks post‐partum There were 6 study therapists: specialist in each of the 3 research treatments and 3 non‐specialists A Therapist Rating Scale was administered to participant to measure adherence to treatment |
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| Outcomes | Follow‐up at 4.5, 9 and 18 months. 5‐year follow‐up for women who had completed therapy Symptoms of depression, as measured using the EPDS. Also, measures of infant‐mother attachment and behaviour | |
| Notes | Primary care condition used as minimal treatment control EPDS data used in depression outcome of review | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "allocated randomly to a treatment group by the study recruiter, who drew one of four coloured balls from a bag" |
| Allocation concealment (selection bias) | High risk | Quote: "...the assignment of each therapy to a different coloured ball having been defined at the start of the study and maintained until the end" Comment: concealment not blinded; therefore, high risk of bias |
| Blinding (performance bias and detection bias) All outcomes | Low risk | Comment: self report data (EPDS) considered low risk of detection bias |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: incomplete data (> 20%) at 5‐year follow‐up; however, comparison between completer only analyses versus ITT aimed to address attrition bias in respect to drop‐out |
| 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 |