Can expressive writing reduce the effects of stress from Hurricane Harvey on pregnant women and their unborn children?

ISRCTN ISRCTN52932563
DOI https://doi.org/10.1186/ISRCTN52932563
Secondary identifying numbers STUDY00000657 (University of Houston IRB)
Submission date
08/05/2020
Registration date
20/07/2020
Last edited
08/06/2021
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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 November 2019 (updated 11/12/2020, previously: 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)

Study website

Contact information

Dr Johanna Bick
Scientific

4849 Calhoun Rd, Room 492
Houston
TX 77204-5022
United States of America

Phone +1-832-442-5396
Email jrbick@uh.edu
Dr Suzanne King
Scientific

6875 Boulevard LaSalle
Montreal
H4H 1R3
Canada

ORCiD logoORCID ID 0000-0003-3055-6846
Phone +1-514-761-6131 ext. 2353
Email suzanne.king@mcgill.ca
Dr David Olson
Scientific

220 Heritage Medical Research Centre
Edmonton
T6G 2S2
Canada

Phone +1-780-492-8559
Email dmolson@ualberta.ca

Study information

Study designSingle-center randomized-controlled three-arm superiority trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Internet/virtual
Study typeOther
Participant information sheet Not available in web format, please use contact details to request a participant information sheet.
Scientific titleRandomized-controlled trial of expressive writing in pregnant women affected by Hurricane Harvey: effects on maternal distress and offspring development
Study objectives1. 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(s)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
Health condition(s) or problem(s) studiedPrenatal maternal stress
InterventionParticipants (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 typeBehavioural
Primary outcome measure1. 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 measures1. 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 study start date15/09/2017
Completion date31/05/2019

Eligibility

Participant type(s)Healthy volunteer
Age groupAdult
Lower age limit18 Years
SexFemale
Target number of participants1,000
Total final enrolment1090
Key inclusion criteria1. 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
Key exclusion criteria1. Twin or multiple pregnancy
Date of first enrolment12/02/2018
Date of final enrolment09/10/2018

Locations

Countries of recruitment

  • United States of America

Study participating centre

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

Sponsor information

University of Houston
University/education

Research Integrity and Oversight
c/o Kirstin Holzschuh
4800 Calhoun Rd
Houston
TX 77204
United States of America

Phone +1-713-743-9740
Email kmholzschuh@uh.edu
Website https://www.uh.edu/research/
ROR logo "ROR" https://ror.org/048sx0r50

Funders

Funder type

Other

Investigator initiated and funded

No information available

Results and Publications

Intention to publish date31/12/2020
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planThe 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 planThe datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol file 12/12/2017 07/08/2020 No No
Basic results 08/06/2021 08/06/2021 No No

Additional files

ISRCTN52932563_PROTOCOL_12Dec17.pdf
uploaded 07/08/2020
ISRCTN52932563_BasicResults_08June2021.pdf
uploaded 08/06/2021

Editorial Notes

08/06/2021: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
3. The basic results have been uploaded as an additional file.
11/12/2020: The following changes were made to the trial record:
1. The overall end date was changed from 31/12/2020 to 31/05/2019.
2. The plain English summary was updated to reflect these changes.
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.