Condition category
Pregnancy and Childbirth
Date applied
08/08/2014
Date assigned
08/08/2014
Last edited
24/10/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Pregnancy does not appear to be protective against the existing or development of new mental disorders. Depression is the most common antenatal mental disorder and can have a considerable impact upon a woman and her family. To date, there has been no study of mild psychological interventions in the antenatal setting which may be more effective and cost-effective for mild and moderate depression during pregnancy. We therefore propose to modify and evaluate Guided Self Help materials for antenatal depression in women using NHS maternity services. This study aims to get initial evidence on the how effective is the Guided Self Help intervention in improving depressive symptoms and other outcomes (e.g. psychological symptoms after giving birth and quality of life) for women with antenatal depression.

Who can participate?
Adult pregnant women who are up to 26 weeks pregnant and having depressive symptoms can take part.

What does the study involve?
Pregnant women experiencing depression will be randomly allocated to either antenatal Guided Self Help (given by an NHS Psychological Wellbeing Practitioner) plus usual care, or to usual care alone. The antenatal Guided Self Help intervention has been modified from existing Guided Self Help materials used in psychological services for the treatment of depression. Modifications include addressing pregnancy-specific worries, and including sections on health issues in pregnancy and planning for parenthood. Women allocated to the this group will be seen for up to eight sessions by a Psychological Wellbeing Practitioner (including an initial assessment session); there will also be a appointment at 12 weeks after delivery. Research measures will be taken from all women before random allocation, after 14 weeks of allocation and at 12 weeks after delivery. Data will also be collected to find out if this method is cost-effective.

What are the possible benefits and risks of participating?
The opportunity to talk about symptoms with a researcher can be beneficial and, where appropriate, participants will be encouraged to discuss concerns with their midwife and given information on sources of help and support, which may be helpful in managing their situation. Some participants may find that being asked questions about their mental health and wellbeing is sensitive, and the potential for the interview to bring up these feelings is described on the Participant Information Sheet. At the beginning of the interview, participants will be asked if there is anyone they would like the researcher to contact for support if they become distressed. Participants will be closely monitored during interviews for signs for distress and appropriate action will be taken. If there are concerns about the health and wellbeing of participants or their children at the end of the interview, participants will be asked if they would like any of the information they disclosed to be conveyed to their clinic midwife.

Where is the study run from?
The study is being run from King’s Health Partners (UK)

When is the study starting and how long is it expected to run for?
October 2014 to June 2017

Who is funding the study?
National Institute for Health Research (NIHR) (UK)

Who is the main contact?
Ms Kylee Trevillion
kylee.trevillion@kcl.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Ms Kylee Trevillion

ORCID ID

http://orcid.org/0000-0001-5865-4726

Contact details

Section of Women's Mental Health
PO 31
16 De Crespigny Park
London
SE5 8AF
United Kingdom
-
kylee.trevillion@kcl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

17048

Study information

Scientific title

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

Acronym

DAWN Trial

Study hypothesis

Women with mild or moderate antenatal depression treated with Guided Self Help will have significantly lower Edinburgh Postnatal Depression Scale (EPDS) depressive symptoms at 14 weeks post-randomisation compared with women with mild or moderate antenatal depression receiving usual care.

Ethics approval

NRES Committee London-Camberwell St Giles, 11/06/2014, ref: 14/LO/0597

Study design

Randomised; Interventional; Design type: Treatment

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Topic: Mental Health, Reproductive health and childbirth; Subtopic: Depression, Reproductive Health and Childbirth (all Subtopics); Disease: Depression, Reproductive Health & Childbirth

Intervention

Women will be randomly assigned to:
1. Guided Self Help (delivered by Psychological Wellbeing Practitioners) plus usual care
2. Usual care alone (i.e., treatment as usual)

Guided Self Help, Details: Existing Guided Self Help materials used in psychological services for the treatment of depression are being modified for pregnancy. The Guided Self Help (with usual care) intervention for antenatal depression is being delivered by NHS Psychological Wellbeing Practitioners (PWPs). The intervention comprises an initial session at the beginning of therapy, followed by up to eight 30-minute sessions. An additional session will also be conducted, at six to eight weeks post-delivery (i.e. before the post-delivery research outcomes are collected)

Intervention type

Other

Phase

Phase II

Drug names

Primary outcome measures

Depression, measured using the Edinburgh Postnatal Depression Scale - depressive symptoms at baseline and 14 weeks

Secondary outcome measures

1. Anxiety, measured using the Generalized Anxiety Disorder Scale (GAD-7) at baseline and 14 weeks
2. Depression, measured using the Patient Health Questionnaire-9 (PHQ-9) at baseline and 14 weeks and the Edinburgh Postnatal Depression Scale and Whooley items at 3 months post-delivery
3. Health-related quality of life, measured using the Short Form Health Survey (SF-6D) at baseline, 14 weeks and 3 months post-delivery
4. Service contacts, measured using the Adult Service Use Schedule at 14 weeks and 3 months post-delivery
5. Parenting stress, measured using the Postpartum Bonding Questionnaire at 3 months post-delivery

Overall trial start date

30/10/2014

Overall trial end date

30/06/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. Pregnant women, up to 26 weeks gestation
2. Aged 16 years or older
3. Meeting the criteria for DSM­-IV depression

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

Planned Sample Size: 110; UK Sample Size: 110

Participant exclusion criteria

1. Pregnant women who are unable to complete the trial questionnaires/workbook in English or provide informed consent
2. Have psychosis, borderline personality disorder, a current eating disorder, current post-traumatic stress disorder, or suicidality and/or are receiving secondary mental health care, psychological therapies or antidepressants

Recruitment start date

30/10/2014

Recruitment end date

30/06/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Croydon Health Services
530 London Road Croydon
London
CR7 7YE
United Kingdom

Trial participating centre

St Thomas' Hospital
10th floor North Wing Westminster Bridge Road
London
SE1 7EH
United Kingdom

Trial participating centre

University Hospital Lewisham
Lewisham High Street London
London
SE13 6LH
United Kingdom

Trial participating centre

South London and Maudsley NHS Foundation Trust
Monks Orchard Road
Beckenham
BR3 3BX
United Kingdom

Trial participating centre

King’s College Hospital
Denmark Hill
London
SE5 9RS
United Kingdom

Sponsor information

Organisation

King's College London (UK)

Sponsor details

Room 1.8 Hodgkin Building
Guy’'s Campus
London
SE1 4UL
United Kingdom
+44 (0)20 7848 6960
keith.brennan@kcl.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal.

Intention to publish date

30/06/2018

Participant level data

Available on request

Results - basic reporting

Publication summary

2016 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/27756349

Publication citations

Additional files

Editorial Notes

24/10/2016: Publication reference added. 22/09/2016: Internal review. 01/09/2016: The outcome measures have been updated to include information about the methods of measurement and timepoints used. 30/08/2016: The trial participating centres, publication and dissemination plan and availability of participant level data and study contact's ORCID ID have been added. 19/07/2016: The recruitment end date has been updated from 30/06/2017 to 30/06/2016. 18/12/2015: The trialist has requested that the participant inclusion criteria be updated to include women up to 26 weeks gestation, rather than 22 weeks, and that having "current post-traumatic stress disorder" be added to the exclusion criteria. All changes were reviewed and approved by the governing ethics committee .