Depression: a trial of antenatal guided self help for women
| ISRCTN | ISRCTN83768230 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN83768230 |
| Secondary identifying numbers | 17048 |
- Submission date
- 08/08/2014
- Registration date
- 08/08/2014
- Last edited
- 07/08/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
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 Kings 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
Contact information
Scientific
Section of Women's Mental Health
PO 31, 16 De Crespigny Park
London
SE5 8AF
United Kingdom
 ORCID ID |
0000-0001-5865-4726 |
|---|---|
| kylee.trevillion@kcl.ac.uk |
Study information
| Study design | Randomised; Interventional; Design type: Treatment |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Depression: an exploratory parallel-group randomised controlled trial of Antenatal guided self help for WomeN (DAWN) |
| Study 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(s) | NRES Committee London-Camberwell St Giles, 11/06/2014, ref: 14/LO/0597 |
| 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 |
| Primary outcome measure | 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 study start date | 30/10/2014 |
| Overall study end date | 30/06/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | Planned Sample Size: 110; UK Sample Size: 110 |
| Total final enrolment | 53 |
| 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 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
- England
- United Kingdom
Study participating centres
Croydon
London
CR7 7YE
United Kingdom
Westminster Bridge Road
London
SE1 7EH
United Kingdom
London
London
SE13 6LH
United Kingdom
Beckenham
BR3 3BX
United Kingdom
London
SE5 9RS
United Kingdom
Sponsor information
University/education
Room 1.8 Hodgkin Building
Guy's Campus
London
SE1 4UL
England
United Kingdom
| Phone | +44 (0)20 7848 6960 |
|---|---|
| keith.brennan@kcl.ac.uk | |
"ROR" |
https://ror.org/0220mzb33 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 30/06/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer reviewed journal. |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 18/10/2016 | Yes | No | |
| Results article | results | 01/01/2020 | 07/08/2020 | Yes | No |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
07/08/2020: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
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 .
