TY - JOUR
T1 - Depression
T2 - An exploratory parallel-group randomised controlled trial of Antenatal guided self help for WomeN (DAWN): Study protocol for a randomised controlled trial
AU - Trevillion, Kylee
AU - Domoney, Jill
AU - Pickles, Andrew
AU - Bick, Debra
AU - Byford, Sarah
AU - Heslin, Margaret
AU - Milgrom, Jeannette
AU - Mycroft, Rachel
AU - Pariante, Carmine
AU - Ryan, Elizabeth
AU - Hunter, Myra
AU - Howard, Louise Michele
N1 - Funding Information:
This paper summarises independent research funded by the National Institute for Health Research (NIHR) under its Programme Grants for Applied Research Programme (Grant Reference Number RP-PG-1210-12002) and partly funded by the National Institute for Health Research (NIHR) Biomedical Research Centre at South London and Maudsley NHS Foundation Trust and King’s College London. Louise Howard is also supported by an NIHR Research Professorship (NIHR-RP-R3-12-011), and Debra Bick is supported by the National Institute for Health Research (NIHR) Collaboration for Leadership in Applied Health Research and Care South London at King’s College Hospital NHS Foundation Trust. The study team acknowledges the study delivery support given by the NIHR South London Clinical Research Network and King’s Clinical Trials Unit. The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health. The funding source and sponsor had no role in the design, execution or dissemination of the results, other than arranging peer review.
Publisher Copyright:
© 2016 The Author(s).
PY - 2016/10/18
Y1 - 2016/10/18
N2 - Background: Depression is a common antenatal mental disorder and is associated with an increased risk of adverse effects on the fetus and significant morbidity for the mother; if untreated it can also continue into the post-natal period and affect mother-infant interactions. There has been little research evaluating the effectiveness or cost-effectiveness of antenatal psychological interventions for antenatal depression, particularly for mild to moderate disorders. International guidelines recommend a stepped care approach starting with Guided Self Help, and the aim of this exploratory trial is to investigate Guided Self Help modified for pregnancy. Methods: The DAWN trial is an exploratory randomised controlled trial of the effectiveness and cost-effectiveness of antenatal Guided Self Help, modified for pregnancy and delivered by National Health Service Psychological Wellbeing Practitioners. Antenatal Guided Self Help, in addition to usual care, is compared with usual care for pregnant women diagnosed with mild to moderate depression and mixed anxiety and depression, using the Structured Clinical Interview for DSM-IV Disorders. Modifications for pregnancy include perinatal mental health training, addressing pregnancy-specific worries and including sections on health issues in pregnancy and planning for parenthood. Women allocated to Guided Self Help will be seen for up to eight sessions by a Psychological Wellbeing Practitioner (including an initial assessment session); there will also be an appointment at 12 weeks after delivery. Research measures including the Edinburgh Postnatal Depression Scale (primary outcome) and other measures of depression, anxiety, quality of life and service use will be collected from women before random allocation, 14 weeks after random allocation and at 12 weeks after delivery. Potential psychological mechanisms of the intervention will be explored using the Pregnancy-Related Thoughts Questionnaire and the Metacognitive Awareness Questionnaire. Discussion: The DAWN trial is the first exploratory trial to investigate the efficacy of antenatal Guided Self Help for pregnant women with mild to moderate depression meeting DSM-IV diagnostic criteria. Recruitment started January 2015 and is expected to be completed by July 2016. Trial registration: ISRCTN registry: ISRCTN83768230. Registered on 8 August 2014.
AB - Background: Depression is a common antenatal mental disorder and is associated with an increased risk of adverse effects on the fetus and significant morbidity for the mother; if untreated it can also continue into the post-natal period and affect mother-infant interactions. There has been little research evaluating the effectiveness or cost-effectiveness of antenatal psychological interventions for antenatal depression, particularly for mild to moderate disorders. International guidelines recommend a stepped care approach starting with Guided Self Help, and the aim of this exploratory trial is to investigate Guided Self Help modified for pregnancy. Methods: The DAWN trial is an exploratory randomised controlled trial of the effectiveness and cost-effectiveness of antenatal Guided Self Help, modified for pregnancy and delivered by National Health Service Psychological Wellbeing Practitioners. Antenatal Guided Self Help, in addition to usual care, is compared with usual care for pregnant women diagnosed with mild to moderate depression and mixed anxiety and depression, using the Structured Clinical Interview for DSM-IV Disorders. Modifications for pregnancy include perinatal mental health training, addressing pregnancy-specific worries and including sections on health issues in pregnancy and planning for parenthood. Women allocated to Guided Self Help will be seen for up to eight sessions by a Psychological Wellbeing Practitioner (including an initial assessment session); there will also be an appointment at 12 weeks after delivery. Research measures including the Edinburgh Postnatal Depression Scale (primary outcome) and other measures of depression, anxiety, quality of life and service use will be collected from women before random allocation, 14 weeks after random allocation and at 12 weeks after delivery. Potential psychological mechanisms of the intervention will be explored using the Pregnancy-Related Thoughts Questionnaire and the Metacognitive Awareness Questionnaire. Discussion: The DAWN trial is the first exploratory trial to investigate the efficacy of antenatal Guided Self Help for pregnant women with mild to moderate depression meeting DSM-IV diagnostic criteria. Recruitment started January 2015 and is expected to be completed by July 2016. Trial registration: ISRCTN registry: ISRCTN83768230. Registered on 8 August 2014.
KW - Depression
KW - Guided Self-Help
KW - Pregnancy
KW - Randomised controlled trial
UR - https://www.scopus.com/pages/publications/84992467550
U2 - 10.1186/s13063-016-1632-6
DO - 10.1186/s13063-016-1632-6
M3 - Article
C2 - 27756349
AN - SCOPUS:84992467550
SN - 1745-6215
VL - 17
JO - Trials
JF - Trials
IS - 1
M1 - 503
ER -
SDG 3 Good Health and Well-being