TY - JOUR
T1 - 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
AU - Challacombe, Fiona
AU - Tinch-Taylor, Rose
AU - Sabin, Katie
AU - Potts, Laura
AU - Lawrence, Vanessa
AU - Howard, Louise
AU - Carter, Ben
N1 - Funding Information:
This work is independent research supported by the National Institute for Health Research (HEE/NIHR ICA Programme Clinical Lectureship, Dr. Fiona Challacombe, ICA-CL-2017-03-013 ). This study is supported by the National Institute for Health Research (NIHR) Applied Research Collaboration South London (NIHR ARC South London) at King's College Hospital NHS Foundation Trust . The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health and Social Care. The NIHR were not involved in the design, data collection, analysis or interpretation of the study, or the decision to submit for publication.
Publisher Copyright:
© 2023
PY - 2023/10/9
Y1 - 2023/10/9
N2 - 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 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. 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.
AB - 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 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. 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.
KW - anxiety-related disorders; cognitive-behaviour therapy; pregnancy; exposure therapy; perinatal; time-intensive treatment
UR - http://www.scopus.com/inward/record.url?scp=85174355465&partnerID=8YFLogxK
U2 - 10.1016/j.jad.2023.10.070
DO - 10.1016/j.jad.2023.10.070
M3 - Article
SN - 0165-0327
VL - 344
SP - 414
EP - 422
JO - Journal of Affective Disorders
JF - Journal of Affective Disorders
ER -