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
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)
Contact information
Scientific
4849 Calhoun Rd, Room 492
Houston
TX 77204-5022
United States of America
| Phone | +1-832-442-5396 |
|---|---|
| jrbick@uh.edu |
Scientific
6875 Boulevard LaSalle
Montreal
H4H 1R3
Canada
 ORCID ID |
0000-0003-3055-6846 |
|---|---|
| Phone | +1-514-761-6131 ext. 2353 |
| suzanne.king@mcgill.ca |
Scientific
220 Heritage Medical Research Centre
Edmonton
T6G 2S2
Canada
| Phone | +1-780-492-8559 |
|---|---|
| dmolson@ualberta.ca |
Study information
| Study design | Single-center randomized-controlled three-arm superiority trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Internet/virtual |
| Study type | Other |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | Randomized-controlled trial of expressive writing in pregnant women affected by Hurricane Harvey: effects on maternal distress and offspring development |
| Study objectives | 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(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) studied | 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 |
| 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 study start date | 15/09/2017 |
| Completion date | 31/05/2019 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 1,000 |
| Total final enrolment | 1090 |
| Key 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 |
| Key exclusion criteria | 1. Twin or multiple pregnancy |
| Date of first enrolment | 12/02/2018 |
| Date of final enrolment | 09/10/2018 |
Locations
Countries of recruitment
- United States of America
Study participating centre
4849 Calhoun Road, Rm 482
Houston
TX 77024
United States of America
Sponsor information
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 |
|---|---|
| kmholzschuh@uh.edu | |
| Website | https://www.uh.edu/research/ |
"ROR" |
https://ror.org/048sx0r50 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 31/12/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| 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 plan | The 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.
