Exposure-based cognitive-behaviour therapy for anxiety-related disorders in pregnancy (ADEPT): Results of a feasibility randomised controlled trial of time-intensive versus weekly CBT

Background: Exposure-based cognitive-behaviour therapies (CBT) are effective but their acceptability in pregnancy is untested. Time-intensive delivery of CBT (INT-CBT) may accelerate treatment response. This feasibility trial aimed to explore this. Methods: This multi-centre parallel-group trial recruited pregnant women with anxiety-related disorders via maternity and mental health settings and randomised (1:1) to INT-CBT (8-10 treatment hours over two weeks) or standard weekly one-hour CBT sessions (WCBT). Both groups also received late pregnancy and postpartum follow-ups. Participants received 10-12 total hours of individual therapy using remote delivery (95 %). Outcomes were assessed: at baseline; after two weeks of treatment, late pregnancy, at 1 and 3 months postpartum (by blinded assessors), alongside a qualitative interview. Pre-specified primary feasibility outcomes regarding acceptability, recruitment and retention were evaluated. The secondary outcome of adjusted mean difference was estimated for the proposed primary outcome. Results: All feasibility outcomes were met. Of 135 screened, 59 women were randomised into the trial (29 INTCBT:30 WCBT). 93 % completed treatment and 81 % provided data at 3 m postpartum. No adverse effects were attributable to treatment. Women receiving INT-CBT showed a reduction in anxiety (GAD-7) after two weeks of treatment compared to WCBT (aMD = -4.17, 95%CI -6.03 to -2.31) with narrower difference at 3-month postpartum aMD = -0.11 (95%CI -3.23, 3.00). Women described the momentum of INT-CBT as helpful to drive change. Conclusions: Exposure-based therapies are acceptable to pregnant women. INT-CBT may reduce anxiety quickly and should be tested in a confirmatory trial examining longer term outcomes. There may be limitations to generalisability from sampling and COVID. Trial registration: doi:https://doi.org/10.1186/ISRCTN81203286 prospectively registered 27/6/2019.