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Published in: Trials 1/2016

Open Access 01-12-2016 | Study protocol

Depression: an exploratory parallel-group randomised controlled trial of Antenatal guided self help for WomeN (DAWN): study protocol for a randomised controlled trial

Authors: Kylee Trevillion, Jill Domoney, Andrew Pickles, Debra Bick, Sarah Byford, Margaret Heslin, Jeannette Milgrom, Rachel Mycroft, Carmine Pariante, Elizabeth Ryan, Myra Hunter, Louise Michele Howard

Published in: Trials | Issue 1/2016

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Abstract

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.
Appendix
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Literature
1.
Howard LM, Molyneaux E, Dennis C-L, et al. Non-psychotic mental disorders in the perinatal period. Lancet. 2014;384:1775–88.CrossRefPubMed
2.
Grote NK, Bridge JA, Gavin AR, et al. A meta-analysis of depression during pregnancy and the risk of preterm birth, low birth weight, and intrauterine growth restriction. Arch Gen Psychiatry. 2010;67:1012–24.CrossRefPubMedPubMedCentral
3.
Howard LM, Kirkwood G, Latinovic R. Sudden infant death syndrome and maternal depression. J Clin Psychiatry. 2007;68:1279–83.CrossRefPubMed
4.
Bick D, Howard L. When should women be screened for postnatal depression? Expert Rev Neurother. 2010;10:151–4.CrossRefPubMed
5.
Milgrom J, Gemmill AW, Bilszta JL, et al. Antenatal risk factors for postnatal depression: a large prospective study. J Affect Disord. 2008;108:147–57.CrossRefPubMed
6.
Underwood L, Waldie K, D'Souza S, Peterson ER, Morton S. A review of longitudinal studies on antenatal and postnatal depression. Arch Womens Ment Hlth. 2016;19(5):711–20.CrossRef
7.
Stein A, Pearson RM, Goodman SH, et al. Effects of perinatal mental disorders on the fetus and child. Lancet. 2014;384:1800–19.CrossRefPubMed
8.
Burke L. The impact of maternal depression on familial relationships. Int Rev Psychiatry. 2003;15:243–55.CrossRefPubMed
9.
Shah N, Howard LM. Screening for smoking and substance misuse in pregnant women with mental illness. Psychiatr Bull. 2006;30:294–7.CrossRef
10.
Howard LM, Bekele D, Rowe M, et al. Smoking cessation in pregnant women with mental disorders: a cohort and nested qualitative study. BJOG. 2012;120:362–70.CrossRefPubMedPubMedCentral
11.
Seguin L, Bouchard C, St-Denis M, et al. Social support network evolution after the birth of their first baby: comparison between lower and middle class mothers. Can J Public Health. 1995;86:392. In French.PubMed
12.
Molyneaux E, Poston L, Ashurst-Williams S, et al. Obesity and mental disorders during pregnancy and postpartum: a systematic review and meta-analysis. Obstet Gynecol. 2014;857–67.
13.
Flach C, Leese M, Heron J, et al. Antenatal domestic violence, maternal mental health and subsequent child behaviour: a cohort study. BJOG. 2011;118:1383–91.CrossRefPubMed
14.
Howard LM, Oram S, Galley H, et al. Domestic violence and perinatal mental disorders: a systematic review and meta-analysis. PLoS Med. 2013;10, e1001452.CrossRefPubMedPubMedCentral
15.
Howard LM, Megnin-Viggars O, Symington I, et al. Antenatal and postnatal mental health: summary of updated NICE guidance. BMJ. 2014;349:g7394.CrossRefPubMed
16.
Dennis CL, Ross LE, Grigoriadis S. Psychosocial and psychological interventions for treating antenatal depression. Cochrane Database Syst Rev. 2007;18:CD006309.
17.
Dennis CL, Dowswell T. Interventions (other than pharmacological, psychosocial or psychological) for treating antenatal depression. status and date: New search for studies and content updated (no change to conclusions). Cochrane Database Syst Rev. 2013. doi:10.​1002/​14651858.​CD006795.​pub3.
18.
Burns A, O’Mahen H, Baxter H, et al. A pilot randomized controlled trial of cognitive behavioural therapy for antenatal depression. BMC Psychiatry. 2013;13:33.CrossRefPubMedPubMedCentral
19.
O’Mahen H, Himle JA, Fedock G, et al. A pilot randomized controlled trial of cognitive behavioral therapy for perinatal depression adapted for women with low incomes. Depress Anxiety. 2013;30:679–87.CrossRefPubMed
20.
Milgrom J, Holt C, Ross J, et al. Feasibility study and pilot randomised trial of an antenatal depression treatment with infant follow-up. Arch Womens Ment Health. 2015;18:717–30.CrossRefPubMed
21.
Department of Health. Perinatal positive practice guide. London: Department of Health; 2009.
22.
Coull G, Morris PG. The clinical effectiveness of CBT-based guided self-help interventions for anxiety and depressive disorders: a systematic review. Psychol Med. 2011;41:2239–52.CrossRefPubMed
23.
Milgrom J, Schembri C, Ericksen J, et al. Towards parenthood: an antenatal intervention to reduce depression, anxiety and parenting difficulties. J Affect Disord. 2011;130:385–94.CrossRefPubMed
24.
Department of Health. IAPT three-year report: The first million patients. London: Department of Health; 2012.
25.
Howard L, Flach C, Mehay A, et al. The prevalence of suicidal ideation identified by the Edinburgh Postnatal Depression Scale in postpartum women in primary care: findings from the RESPOND trial. BMC Pregnancy Childbirth. 2011;11:57.CrossRefPubMedPubMedCentral
26.
Whooley MA, Avins AL, Miranda J, et al. Case-finding instruments for depression. Two questions are as good as many. J Gen Intern Med. 1997;12:439–45.CrossRefPubMedPubMedCentral
27.
Delgadillo J, McMillan D, Lucock M, et al. Early changes, attrition, and dose–response in low intensity psychological interventions. Br J Clin Psychol. 2013. doi:10.​1111/​bjc.​12031.PubMed
28.
29.
Spitzer RL, Kroenke K, Williams JB, et al. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006;166:1092–7.CrossRefPubMed
30.
Improving Access to Psychological Therapies. The IAPT data handbook: guidance on recording and monitoring outcomes to support local evidence-based practice. London: IAPT Programme; 2011.
31.
Mundt JC, Marks IM, Shear MK, et al. The Work and Social Adjustment Scale: a simple measure of impairment in functioning. Br J Psychiatry. 2002;180:461–4.CrossRefPubMed
32.
Martin DJ, Garske JP, Davis MK. Relation of the therapeutic alliance with outcome and other variables: a meta-analytic review. J Consult Clin Psychol. 2000;68:438.CrossRefPubMed
33.
Moncher FJ, Prinz RJ. Treatment fidelity in outcome studies. Clin Psychol Rev. 1991;11:247–66.CrossRef
34.
Kazdin AE. Mediators and mechanisms of change in psychotherapy research. Annu Rev Clin Psychol. 2007;3:1–27.CrossRefPubMed
35.
Blackburn I-M, James IA, Milne DL, et al. The revised cognitive therapy scale (CTS-R): psychometric properties. Behav Cogn Psychother. 2001;29:431–46.CrossRef
36.
Rogers C. On becoming a person: a therapist’s view of psychotherapy. Boston: Houghton Mifflin Harcourt; 2012.
37.
NVivo. NVivo qualitative data analysis software (version 8). Southport: QSR International; 2008.
38.
Ritchie J, Spencer L, editors. Qualitative data analysis for applied policy research. London: Routledge; 1994.
39.
Philips Z, Ginnelly L, Sculpher M, et al. Review of guidelines for good practice in decision-analytic modelling in health technology assessment. Health Technol Assess. 2004;8:iii–iv, ix–xi, 1–158.
40.
Efron B, Tibshirani RJ. An introduction to the bootstrap. New York: Chapman & Hall; 1993.CrossRef
41.
Thompson SG, Barber JA. How should cost data in pragmatic randomised trials be analysed? Br Med J. 2000;320:1197–200.CrossRef
42.
Byford S. The validity and responsiveness of the EQ-5D measure of health-related quality of life in an adolescent population with persistent major depression. J Ment Health. 2013;22:101–10.CrossRefPubMed
43.
Mulhern B, Mukuria C, Barkham M, et al. Using generic preference-based measures in mental health: psychometric validity of the EQ-5D and SF-6D. Br J Psychiatry. 2014;205:236–43.CrossRefPubMed
44.
Fenwick E, Byford S. A guide to cost-effectiveness acceptability curves. Br J Psychiatry. 2005;187:106–8.CrossRefPubMed
45.
General Medical Counci. Confidentiality. London: General Medical Council; 2009.
Metadata
Title
Depression: an exploratory parallel-group randomised controlled trial of Antenatal guided self help for WomeN (DAWN): study protocol for a randomised controlled trial
Authors
Kylee Trevillion
Jill Domoney
Andrew Pickles
Debra Bick
Sarah Byford
Margaret Heslin
Jeannette Milgrom
Rachel Mycroft
Carmine Pariante
Elizabeth Ryan
Myra Hunter
Louise Michele Howard
Publication date
01-12-2016
Publisher
BioMed Central
Published in
Trials / Issue 1/2016
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-016-1632-6

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