Exposure-based cognitive-behaviour therapy for anxiety disorders in pregnancy (ADEPT): results of a feasibility randomised controlled trial

BackgroundExposure-based cognitive-behaviour therapies (CBT) are effective but their acceptability in pregnancy is untested, despite affecting 15% of women. Time-intensive delivery of CBT (INT-CBT) may accelerate treatment response. AimsTo test the acceptability and feasibility of a trial of INT-CBT for antenatal anxiety disordersMethodThis multi-centre parallel-group trial recruited pregnant women with anxiety disorders from maternity and mental health settings and randomised (1:1) to INT-CBT or standard weekly CBT (WCBT). Participants received 12 hours of individual therapy using remote delivery (95%). Outcomes were assessed: at baseline; during treatment at week 2 and 6, and at 1 month and 3 months postpartum (by blinded assessors), alongside a qualitative interview. Pre-specified primary feasibility outcomes were evaluated and adjusted mean difference estimated for the proposed study primary outcome.ResultsAll feasibility outcomes were met. Of 135 screened, 59 women were recruited and randomised into the trial (29 INT-CBT :30 WCBT). 93% completed treatment and 81% provided data at 3m postpartum. No adverse effects were attributable to treatment. Women randomised to INT-CBT showed a reduction in anxiety (GAD-7) after two weeks of treatment (aMD=-4.17, 95%CI -6.03 to -2.31). There were differences in late pregnancy aMD=-1.72 (95%CI -3.99, 0.56), 1-month postpartum aMD=-2.13 (95%CI -5.14, 0.89), 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.