Evidence map›Paper›PMID 27756349›Full record

Trial reportTrials2016

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

Kylee Trevillion, Jill Domoney, Andrew Pickles, Debra Bick, Sarah Byford, Margaret Heslin, Jeannette Milgrom, Rachel Mycroft, Carmine Pariante, Elizabeth Ryan and 2 more

Open access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
1.8field-weighted citation impact, top 12% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 17 citations in OpenAlex.

  1. Article
  2. Review
  3. Article
  4. Article
  5. Article
  6. Observational
  7. Article
  8. Article
  9. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors at 2 institutions in 2 countries.

Kylee TrevillionInstitute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.
Jill DomoneyInstitute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.
Andrew PicklesInstitute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.
Debra BickFlorence Nightingale Faculty of Nursing and Midwifery, Division of Women's Health, King's College London, London, UK.
Sarah ByfordInstitute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.
Margaret HeslinInstitute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.
Jeannette MilgromUniversity of Melbourne and Parent-Infant Research Institute, Melbourne, Australia.
Rachel MycroftInstitute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.
Carmine ParianteInstitute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.
Elizabeth RyanInstitute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.
Myra HunterInstitute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.
Louise Michele HowardInstitute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK. louise.howard@kcl.ac.uk.ORCID 0000-0001-9942-744X
King's College London · GBThe University of Melbourne · AU

Funding

Department of Health NIHR-RP-R3-12-011Department of Health RP-PG-1210-12002Medical Research Council G108/603
6 · The paper itself

Abstract

backgroundDepression 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.

methodsThe 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 registrationISRCTN registry: ISRCTN83768230 . Registered on 8 August 2014.

Indexed as

Clinical ProtocolsPrenatal CareDepressionFemaleHumansMental HealthPregnancyPregnancy ComplicationsSample SizeDepressionGuided Self-HelpPregnancyRandomised controlled trial

Identifiers

PMID27756349
PMCPMC5070149
OpenAlexW2536448219

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.