Condition category
Pregnancy and Childbirth
Date applied
08/05/2020
Date assigned
20/07/2020
Last edited
07/08/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Every year, hundreds of millions of people around the globe are affected by natural disasters. In pregnant women, not only mental health can be affected by this stress, but also the pregnancy itself, as well as the developing brain of their unborn children. To alleviate these consequences, the study aims to test an intervention called “expressive writing”, where affected women write in a journal their deepest thoughts and feelings related to current and past trauma.

Who can participate?
Women aged 18-45 years old who were living in the Greater Houston area and pregnant at the time of Hurricane Harvey’s landing (August 25, 2017) or who conceived in the six months that followed.

What does the study involve?
All recruitment, questionnaires and interventions are done online. Participants are randomly allocated to one of three groups. Participants in the expressive writing group are asked to write for daily sessions of 20 minutes, across four days, about intimate trauma-related topics. Participants in the neutral writing group are instructed to write about factual topics for an equal number of sessions. Another group of participants has no writing task (control group). None of the participants receive feedback about what they wrote, and all texts are de-identified and remain confidential. Participants are sent online questionnaires at recruitment and at 2 months after the intervention, as well as 6 months after childbirth.

What are the possible benefits and risks of participating?
Possible benefits of participating include a reduction of maternal stress levels, better pregnancy outcomes and better future development of the unborn children. Risks are minimal and relate mostly to the transient stress that can be experienced while disclosing intimate thoughts and feelings during the writing sessions.

Where is the study run from?
University of Houston, Houston, Texas (USA)

When is the study starting and how long is it expected to run for?
September 2017 to December 2020

Who is funding the study?
The study is self-funded by its investigators.

Who is the main contact:?
1. Dr. Johanna Bick (jrbick@uh.edu)
2. Dr. Suzanne King (suzanne.king@mcgill.ca)
3. Dr. David Olson (dmolson@ualberta.ca)

Trial website

http://vantageppc.com/harvey-study/

Contact information

Type

Scientific

Primary contact

Dr Johanna Bick

ORCID ID

Contact details

4849 Calhoun Rd
Room 492
Houston
TX 77204-5022
United States of America
+1-832-442-5396
jrbick@uh.edu

Type

Scientific

Additional contact

Dr Suzanne King

ORCID ID

http://orcid.org/0000-0003-3055-6846

Contact details

6875 Boulevard LaSalle
Montreal
H4H 1R3
Canada
+1-514-761-6131 ext. 2353
suzanne.king@mcgill.ca

Type

Scientific

Additional contact

Dr David Olson

ORCID ID

Contact details

220 Heritage Medical Research Centre
Edmonton
T6G 2S2
Canada
+1-780-492-8559
dmolson@ualberta.ca

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

STUDY00000657 (University of Houston IRB)

Study information

Scientific title

Randomized-controlled trial of expressive writing in pregnant women affected by Hurricane Harvey: effects on maternal distress and offspring development

Acronym

Study hypothesis

1. Expressive writing will lead to a decrease in maternal symptoms of poor mental health compared to neutral writing or no writing as assessed two months after the intervention
2. Expressive writing will lead to better birth outcomes (less Caesarean delivery and less preterm birth), better growth and better cognitive, behavioural and motor performance in offspring

Ethics approval

Approved 08/12/2017, Institutional Review Board of the University of Houston (4302 University Dr., Houston, TX 77204, USA; avargas2@uh.edu; +1 713 7439215), ref: STUDY00000657

Study design

Single-center randomized-controlled three-arm superiority trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Internet

Trial type

Other

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

Prenatal maternal stress

Intervention

Participants (mothers) are randomly assigned to one of the three groups: expressive writing (intervention), neutral writing (active control) and no writing (passive control). Participants are assigned to one of the groups using block randomization with full allocation concealment using an automatized, web-based platform (REDCap). Participants are not blinded to assignment but are blinded to the hypotheses. Masking is not conducted, since maternal and offspring outcomes are self-reported.

The intervention is expressive writing as per protocols described by James Pennebaker. Participants (mothers) in this arm are instructed to write their deepest thoughts and feelings about experiences of trauma and conflicts for daily sessions of 20 minutes, for four days. No feedback is provided.
The active control is neutral writing. Participants (mothers) in this arm are instructed to write about factual details of their lives for daily sessions of 20 minutes, for four days. No feedback is provided.
The passive control is no writing.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

1. Maternal PTSD symptoms at baseline and at 2 months post-intervention, as measured with the Impact of Event Scale-Revised (IES-R)
2. Offspring birth outcomes (date and mode of delivery), as measured at 6 months post-partum using an online questionnaire
3. Offspring neurodevelopment at age 6 months as measured with the Ages and Stages-3 questionnaire. There is the potential to continue follow-up assessments of the children at a later date

Secondary outcome measures

1. Maternal depression and anxiety symptoms at baseline and at 2 months post-intervention, as measured with a modified 40-item version of the Inventory of Depression and Anxiety Scales (IDAS), including scales for depression, anxiety, panic, ill temper and well-being
2. Offspring temperament, as measured with the Infant Behavior Questionnaire-Revised at age 6 months

Overall trial start date

15/09/2017

Overall trial end date

31/12/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Pregnant at the time of Hurricane Harvey’s landing (August 25, 2017), or who conceived within 6 months after the flood, and their offspring
2. English-speaking
3. Aged 18 - 45 years
4. Living in Greater Houston area at the time of Hurricane Harvey

Participant type

Healthy volunteer

Age group

Adult

Gender

Female

Target number of participants

1,000

Participant exclusion criteria

1. Twin or multiple pregnancy

Recruitment start date

12/02/2018

Recruitment end date

09/10/2018

Locations

Countries of recruitment

United States of America

Trial participating centre

University of Houston
Department of Psychology 4849 Calhoun Road, Rm 482
Houston
TX 77024
United States of America

Sponsor information

Organisation

University of Houston

Sponsor details

Research Integrity and Oversight
c/o Kirstin Holzschuh
4800 Calhoun Rd
Houston
TX 77204
United States of America
+1-713-743-9740
kmholzschuh@uh.edu

Sponsor type

University/education

Website

https://www.uh.edu/research/

Funders

Funder type

Other

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The first manuscript is expected to be submitted for publication in a scientific journal by the end of 2020. Participants will be informed of the overall study findings as the study progresses.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request.

Intention to publish date

31/12/2020

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

07/08/2020: Uploaded protocol (not peer reviewed) Version n/a 12 December 2017. 27/05/2020: Trial’s existence confirmed by University of Houston.