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An exploratory parallel-group randomised controlled trial of antenatal Guided Self-Help (plus usual care) versus usual care alone for pregnant women with depression : DAWN trial
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Trevillion, K., Ryan, E. G., Pickles, A., Heslin, M., Byford, S., Nath, S., Bick, Debra, Milgrom, J., Mycroft, R., Domoney, J., Pariante, C., Hunter, M. S. and Howard, L. M. (2020) An exploratory parallel-group randomised controlled trial of antenatal Guided Self-Help (plus usual care) versus usual care alone for pregnant women with depression : DAWN trial. Journal of Affective Disorders, 261 . pp. 187-197. doi:10.1016/j.jad.2019.10.013 ISSN 0165-0327.
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Official URL: http://dx.doi.org/10.1016/j.jad.2019.10.013
Abstract
Background:
Depression is a common antenatal mental disorder associated with significant maternal morbidity and adverse fetal outcomes. However, there is a lack of research on the effectiveness or cost-effectiveness of psychological interventions for antenatal depression.
Methods:
A parallel-group, exploratory randomised controlled trial across five hospitals. The trial compared Guided Self-Help, modified for pregnancy, plus usual care with usual care alone for pregnant women meeting DSM-IV criteria for mild-moderate depression. The trial objectives were to establish recruitment/follow-up rates, compliance and acceptability, and to provide preliminary evidence of intervention efficacy and cost-effectiveness. The primary outcome of depressive symptoms was assessed by blinded researchers using the Edinburgh Postnatal Depression Scale at 14-weeks post-randomisation.
Results:
620 women were screened, 114 women were eligible and 53 (46.5%) were randomised. 26 women received Guided Self-Help – 18 (69%) attending ≥4 sessions - and 27 usual care; n = 3 women were lost to follow-up (follow-up rate for primary outcome 92%). Women receiving Guided Self-Help reported fewer depressive symptoms at follow-up than women receiving usual care (adjusted effect size −0.64 (95%CI: −1.30, 0.06) p = 0.07). There were no trial-related adverse events. The cost-effectiveness acceptability curve showed the probability of Guided Self-Help being cost-effective compared with usual care ranged from 10 to 50% with a willingness-to-pay range from £0 to £50,000.
Conclusions and Limitations:
Despite intense efforts we did not meet our anticipated recruitment target. However, high levels of acceptability, a lack of adverse events and a trend towards improvements in symptoms of depression post-treatment indicates this intervention is suitable for talking therapy services.
Item Type: | Journal Article | |||||||||||||||||||||||||||
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Subjects: | R Medicine > RG Gynecology and obstetrics | |||||||||||||||||||||||||||
Divisions: | Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Clinical Trials Unit Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Health Sciences Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School |
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Library of Congress Subject Headings (LCSH): | Postpartum depression -- Research -- Methodology, Prenatal care, Postnatal care, Medical protocols -- Evaluation | |||||||||||||||||||||||||||
Journal or Publication Title: | Journal of Affective Disorders | |||||||||||||||||||||||||||
Publisher: | Elsevier Science BV | |||||||||||||||||||||||||||
ISSN: | 0165-0327 | |||||||||||||||||||||||||||
Official Date: | 15 January 2020 | |||||||||||||||||||||||||||
Dates: |
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Volume: | 261 | |||||||||||||||||||||||||||
Page Range: | pp. 187-197 | |||||||||||||||||||||||||||
DOI: | 10.1016/j.jad.2019.10.013 | |||||||||||||||||||||||||||
Status: | Peer Reviewed | |||||||||||||||||||||||||||
Publication Status: | Published | |||||||||||||||||||||||||||
Access rights to Published version: | Open Access (Creative Commons) | |||||||||||||||||||||||||||
Date of first compliant deposit: | 19 December 2019 | |||||||||||||||||||||||||||
Date of first compliant Open Access: | 23 December 2019 | |||||||||||||||||||||||||||
RIOXX Funder/Project Grant: |
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