Abstract
A pilot study of cognitive analytic therapy (CAT) plus treatment as usual (TAU), versus TAU in stressed pregnant women with anxiety and depression was undertaken as an essential preliminary to any definitive, randomised controlled trial (RCT). The trial was pragmatic, multicentre, parallel, randomised, controlled, and unblinded. Participants were pregnant woman screened using the Hospital Anxiety and Depression Scale (HADS). Treatment was standard 16 session CAT. Main outcome measures: Spielberger State/Trait Anxiety Inventory (STAI) (primary outcome measure) at 24 weeks post‐randomisation, therefore one month post‐therapy for the CAT group; HADS; CORE‐OM, EPDS; SF36, and a brief ‘experience of therapy’ questionnaire, completed at baseline, and on average at 12, 24, 40 and 82 weeks post‐randomisation. 39 patients (CAT + TAU n=20: TAU =19) were randomised with mean baseline STAI‐STATE scores of 50.8 (SD 11.4) and 51.1 (13.3) respectively. 16 patients had missing primary outcome data leaving 23 (n=11, n=12) patients for analysis. The mean STAI‐STATE score was 38.5 (SD 13.8) and 45.7 (16.8) in the CAT and TAU groups respectively at 24 weeks post‐randomisation; an adjusted difference in means of 7.2 (95% CI: ‐7.9 to 20.6). No safety issues were reported. Patient retention for the CAT group was high (18/20; 90% of patients completed therapy). 10/11 (90.9%) respondents ‘agreed’ or ‘strongly agreed’ that having CAT had been ‘very helpful’. The study demonstrated the feasibility of safely undertaking CAT in this setting. Outcomes showed positive trends compatible with a clinically important effect although statistically‐definitive conclusions cannot be drawn in such a study.