STRAWB2 (Stress and Wellbeing After Childbirth): a randomised controlled trial of targeted self-help materials to prevent post-traumatic stress disorder following childbirth.

<bold>Objectives: </bold>To test whether providing psychological self-help materials would significantly lower the incidence of post-traumatic stress disorder (PTSD) at 6-12 weeks postnatally.<bold>Design: </bold>Open-label randomised controlled trial, with blinded outcome assessment.<bold>Setting: </bold>Community midwifery services in two National Health Service (NHS) trusts in the North West.<bold>Sample: </bold>A cohort of 2419 women receiving normal NHS postnatal care.<bold>Methods: </bold>Midwives screened women for traumatic birth experience; 678 women who screened positively (28.1%) were randomly allocated to self-help with usual care (n = 336) or to usual care alone (n = 342). The self-help materials were a leaflet and online film designed to prevent the development of PTSD after trauma exposure through explaining how to manage early psychological responses.<bold>Main Outcome Measure: </bold>The primary outcome was a composite of diagnostic and subdiagnostic PTSD at 6-12 weeks postnatally using the gold-standard Clinician-Administered PTSD Scale (CAPS-5) interview.<bold>Results: </bold>Of the 678 women correctly randomised plus the nine women randomised in error, 478 (70.5%) were followed up. Diagnostic or subdiagnostic PTSD rates at follow-up did not differ between groups who received self-help (26.7%, 65/243) or usual care alone (26.2%, 64/244) (intention-to-treat analysis: RR 1.02, 95% CI 0.68-1.53). Findings remained consistent in the per-protocol analysis (RR 1.04, 95% CI 0.85-1.27). Women viewed the materials very positively. There were no adverse effects. Health economic micro-costing indicated implementation would be very low cost.<bold>Conclusions: </bold>Many women experience a traumatic birth and risk developing PTSD, but self-help strategies without professional support are insufficient and should not be routinely introduced.<bold>Tweetable Abstract: </bold>Self-help information alone does not reduce the number of women developing PTSD after a traumatic childbirth. [ABSTRACT FROM AUTHOR]