This study was funded by the NHS Health Technology Assessment (HTA) Programme. It assessed the effectiveness and cost-effectiveness of training health visitors with one of two psychologically informed approaches to supporting mothers considered to be at risk of developing post-natal depression.
The study was a prospective cluster randomised trial. 101 general practices within the Trent area of England were randomised to either intervention or control (2:1). Intervention practices requested that their health visitors undertake additional training to deliver psychologically informed sessions to mothers based on cognitive behavioural or person centred principles (1:1).
2749 women were allocated to intervention and 1335 to control. This equated to 89 health visitors and 63 clusters in the intervention group and 49 health visitors and 38 clusters in the control group. Mothers were followed up for 18 months.
The main outcome measures were the proportion of mothers with a score ≥12 on the Edinburgh Postnatal Depression Scale (EPDS) at six months. Secondary
Outcome measures were mean EPDS score, Clinical Outcomes in Routine Evaluation (CORE) score, State-Trait Anxiety Inventory (STAI), SF-12, and Parenting Stress Index Short Form (PSI-SF).
In summary, the trial showed that mothers that received support form health visitors that had been trained to deliver one of the psychologically informed approaches had better health outcomes as measured by most of the health related quality of life measures. Additionally, the interventions were found to be cost-effective. These findings were broadly repeated in both mothers at risk of developing post natal depression (EPDS≥12) and all mothers irrespective of EPDS score.
The HTA report is available electronically free of charge (http://www.hta.ac.uk/1336).
The main clinical results of the study have also been published in the British Medical Journal (BMJ 2009; 338:276-280).
Details of the final trial protocol and protocol amendments are available via the link on the right.
Trial registration number is ISRCTN92195776.