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

Abstract

BackgroundExposure-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. MethodsThis 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. ResultsAll feasibility outcomes were met. Of 135 screened, 59 women were randomised into the trial (29 INT-CBT: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. ConclusionsExposure-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.