Condition category
Pregnancy and Childbirth
Date applied
10/09/2013
Date assigned
10/09/2013
Last edited
06/05/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
We are looking at self-help interventions that can improve women’s health after they have had a baby. Getting people to regularly write about stress or difficulties is a simple, low-risk intervention that has been shown to improve psychological and physical health in many groups of people. Although writing interventions may be helpful to women after birth, this has not been tried or tested. We have therefore developed a self-help writing intervention for new mothers. A previous small study showed women find it acceptable and helpful but we now need to test it to see whether writing does actually improve women's psychological and physical health.

Who can participate?
You are eligible to take part if you are over 18 years of age, have given birth in the previous six weeks, and your baby was born after the 26th week of pregnancy.

What does the study involve?
If you decide to take part, you will be randomly allocated to one of three groups. Everyone in these groups will be asked to fill in a questionnaire at three time points: at the beginning of the study, one month later and six months later. Most of you will also be asked to engage in a simple writing exercise where you write for at least 15 minutes every day for three days. The writing task either involves writing about (1) the event or difficulty that has been most stressful and upsetting since having the baby; or (2) a familiar room of your choice. The questionnaires will ask you about your psychological well-being, physical health, and your use of health services. You will be sent text message reminders when you need to complete the writing exercises or the questionnaires. We will also collect some information about the birth of your baby from your medical records.

What are the possible benefits and risks of participating?
We anticipate women who do the writing exercise will have some health benefits but cannot be sure until the completion of the study. If the self-help intervention is effective, it can immediately be provided to all women after birth via the internet. It will therefore provide immediate access to an easy self-help intervention to improve health in postnatal women. There are no foreseeable risks. However, some people might find that completing the study raises feelings or issues that they would like to talk about. If you find completing the booklet distressing you can contact us on [HABIT tel: 020 7040 5864] or the NCT Helpline, a large UK charity supporting parents (tel. 0300 330 0700).

Where is the study run from?
The study is led by Professor Susan Ayers at City University London, in collaboration with Brighton and Sussex University Hospitals and the East Sussex Healthcare NHS Trust (UK).

When is the study starting and how long is it expected to run for?
The study is expected to start sending out initial information to new mums in October 2013, and then to start asking ladies to take part from the beginning of December 2013. We will be looking for new mums to take part for up to 10 months. This will allow us to finish collecting and analysing information by the middle of 2014.

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

Who is the main contact?
Prof. Susan Ayers
susan.ayers@city.ac.uk

Trial website

https://blogs.city.ac.uk/habit/

Contact information

Type

Scientific

Primary contact

Prof Susan Ayers

ORCID ID

http://orcid.org/0000-0002-6153-2460

Contact details

School of Health Sciences
20 Bartholomew Close
London
EC1A 7QN
United Kingdom
-
susan.ayers@city.ac.uk

Type

Scientific

Additional contact

Ms Alex Thornton

ORCID ID

Contact details

Centre for Maternal and Child Health Research
School of Health Sciences
City University London
Northampton Square
London
EC1V 0HB
United Kingdom
-
alex.thornton@city.ac.uk

Type

Scientific

Additional contact

Dr Rosalind Crawley

ORCID ID

http://orcid.org/0000-0002-2321-463X

Contact details

Department of Psychology
University of Sunderland
St Peter’s Way
Sunderland
SR6 0DD
United Kingdom
-
roz.crawley@sunderland.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

14390

Study information

Scientific title

Using expressive writing interventions to promote health in women after birth: a randomised controlled trial

Acronym

HABIT

Study hypothesis

Giving birth is an important life event that raises specific challenges such as adjusting to the demands of a new baby.

Whilst this is usually a positive time, some women develop psychological problems such as depression or anxiety that have profound negative effects on them and their families.

Improving postnatal health is therefore a priority. NHS guidelines state that “improving the health and welfare of mothers and their children is the surest way to a healthier nation” and emphasise the need for postnatal intervention.

Getting people to regularly write about their thoughts and feelings (expressive writing) is a simple, low-risk and inexpensive intervention that in several groups has been shown to improve health and quality of life.

Although expressive writing interventions may be helpful to women after birth this has not been tried or tested. We have therefore developed an expressive writing intervention for new mothers following a feasibility study showing that the majority of women find expressive writing acceptable and helpful. It now needs to be tested to see whether expressive writing can actually improve women's psychological and physical health, quality of life and reduce healthcare service use.

This will be done by recruiting new mothers and randomly allocating them to one of three groups: an expressive writing group (writing their thoughts and feelings about stressful or difficult issues during or after birth), a control intervention group (writing about a familiar room), or normal care. The results of this study could have substantial benefits for the postnatal care provided by the NHS.

If expressive writing is effective, this research will provide immediate access to a cost-effective intervention that improves health in postnatal women, and which can be accessed directly by women via the internet. This can be made available immediately, both locally and nationally.

Ethics approval

London Riverside, First MREC approval date 25/01/2013, ref: 12/LO/1753

Study design

Randomised interventional prevention trial

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 below to request a patient information sheet

Condition

Topic: Mental Health Research Network, Reproductive Health and Childbirth; Subtopic: Anxiety, Depression, Reproductive Health and Childbirth (all Subtopics); Disease: Depression, Anxiety, Reproductive Health & Childbirth

Intervention

366 women divided between three conditions. Women consenting to participate will be randomised on a 1:1:1 ratio.

1. Expressive writing group (writing their thoughts and feelings about stressful or difficult issues during or after birth) - Expressive writing on three days during a one week period.
2. A control intervention group (writing about a familiar room)
3. Normal care.

Women complete a baseline questionnaire, the intervention and then have a subsequent questionnaire 1 month post-intervention and 6 months post-intervention.

Total duration of follow-up: 6 months.

Study Entry : Single Randomisation only

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Psychological/physical health and QoL; Timepoint(s): 1 month and 6 months post intervention

Secondary outcome measures

1. Acceptability of expressive writing to postnatal women; Timepoint(s): 6 months post intervention (women randomised to writing groups only)
2. Changes in healthcare service use; Timepoint(s): 1 month and 6 months post intervention

Overall trial start date

19/08/2013

Overall trial end date

19/06/2015

Reason abandoned

Eligibility

Participant inclusion criteria

Women will be eligible for the study if they are over the age of 18 and have given birth after 26 weeks gestation within the previous 6 weeks.

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

Planned Sample Size: 366; UK Sample Size: 366; Sample size is final anticipated sample size, allowing for attrition. We will be looking to recruit 450 new mothers.

Participant exclusion criteria

Women will be excluded if their baby is stillborn or dies before discharge from hospital.

Recruitment start date

01/11/2013

Recruitment end date

01/12/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Brighton and Sussex University Hospitals NHS Trust
-

Trial participating centre

Mid Staffordshire NHS Foundation Trust
-

Trial participating centre

Southport & Ormskirk Hospital NHS Trust
-

Trial participating centre

Harrogate and District NHS Foundation Trust
-

Trial participating centre

Lancashire Teaching Hospitals NHS Foundation Trust
-

Trial participating centre

Western Sussex Hospitals NHS Trust
-

Trial participating centre

Surrey and Sussex Healthcare NHS Trust
-

Trial participating centre

St Helens and Knowsley Teaching Hospitals NHS Trust
-

Trial participating centre

University Hospital Southampton NHS Foundation Trust
-

Trial participating centre

Kettering General Hospital NHS Foundation Trust
-

Trial participating centre

North Tees & Hartlepool NHS Foundation Trust
-

Sponsor information

Organisation

Brighton and Sussex University Hospitals NHS Trust (UK)

Sponsor details

Royal Sussex County Hospital
Eastern Road
Brighton
BN2 5BE
United Kingdom

Sponsor type

Hospital/treatment centre

Website

http://www.bsuh.nhs.uk/

Funders

Funder type

Government

Funder name

NIHR Research for Patient Benefit (RfPB); Grant Codes: PB-PG-0211-24096

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Findings from the study will be presented at conferences in 2015-2016:
Society of Reproductive & Infant Psychology 35th Annual Conference. University of Nottingham, UK. 14th-15th September 2015
18th International Society for Psychosomatic Obstetrics & Gynaecology Congress. La Termica, Malaga, Spain. 12th-14th May 2016
British Association for Behavioural and Cognitive Psychotherapies 44th Annual Conference & Workshops. The Waterfront, Belfast. 14th-17th June 2016
Publications of results expected late 2016 (to be confirmed)

Intention to publish date

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes