Swiss TrAumatic biRth Trial

NCT03576586 | Completed DMC

• 1 other identifier: 2017-02142
• Study Type: interventional
• Target: 147
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled study aims to investigate the effects of a brief computerized intervention (the computer game "Tetris") on intrusive memories and other posttraumatic stress symptoms following an emergency cesarean section (ECS). Women who have undergone an emergency cesarian section will be randomly allocated to either the brief computerized intervention plus usual care or an attention placebo control group plus usual care within the first 6 hours following the ECS. Women and their infants will be followed up at ≤ 1 week postpartum, 6 weeks postpartum, and 6 months postpartum. It is predicted that women given the brief computerized intervention will develop fewer intrusive memories and less posttraumatic stress symptoms than those who are not. This will inform the development of a simple computerized early intervention to prevent distressing psychological symptoms after a traumatic event, such as an ECS.

Conditions

Posttraumatic Stress Disorder; Acute Stress Disorder

Outcome Measures

Primary Outcomes (2)

• presence and severity of PTSD symptoms: clinician-rated (mother)

  Clinician-administered PTSD scale (CAPS): subscale and total scores

  6 weeks postpartum

• presence and severity of PTSD symptoms: self-report (mother)

  PTSD Checklist (PCL-5): subscale and total scores

  6 weeks postpartum

Secondary Outcomes (17)

• frequency of intrusive traumatic memories (mother)

  ≤ 1 week postpartum

• presence and severity of ASD symptoms (mother)

  < 6 hours after ECS, ≤ 1 week postpartum

• presence and severity of PTSD symptoms: self-report (mother)

  6 months postpartum

• presence and severity of PTSD symptoms: clinician-rated (mother)

  6 months postpartum

• presence and severity of anxiety symptoms (mother)

  < 6 hours after ECS, ≤ 1 week, 6 weeks, 6 months postpartum

Other Outcomes (19)

• morningness-eveningness (mother)

  ≤ 1 week postpartum

• social support (mother, partner)

  ≤ 1 week, 6 weeks, 6 months postpartum

• couple relationship adjustment (mother, partner)

  ≤ 1 week, 6 weeks, 6 months postpartum

Study Arms (2)

Intervention

EXPERIMENTAL

Brief computerized intervention (computer game "Tetris") plus usual care in the maternity department

Behavioral: Brief computerized intervention

Control

PLACEBO COMPARATOR

Attention placebo control (cognitive task for same amount of time) plus usual care in the maternity department

Behavioral: Attention placebo control

Interventions

Brief computerized intervention BEHAVIORAL

Brief computerized intervention (computer game "Tetris") plus usual care in the maternity department

Intervention

Attention placebo control BEHAVIORAL

Brief cognitive task plus usual care in the maternity department

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women:
• had an ECS at ≥ 34 weeks gestation
• gave birth to a live baby
• answered with a score of ≥ 2 separately for at least two out of four screening questions regarding perceived threat
• gave written consent
• Partners:
• if the woman agrees to participate
• was present at the childbirth
• gave written consent

You may not qualify if:

• Women:
• don't speak French sufficiently well to participate in assessments
• have an established intellectual disability or psychotic illness
• severe illness of mother or infant (e.g. cancer, cardiovascular disease, severe neurodevelopmental difficulties, malformations)
• infant requires intensive care
• alcohol abuse and/or illegal drug use during pregnancy
• Partner:
• \- don't speak French sufficiently well to participate in assessments

Sponsors & Collaborators

• Centre Hospitalier Universitaire Vaudois: lead
• University of Lausanne: collaborator
• University Hospital, Geneva: collaborator
• University of Fribourg: collaborator
• University of Zurich: collaborator

Study Sites (1)

Prof. Antje Horsch

Lausanne, 1010, Switzerland

Location

Related Publications (3)

• Horsch A, Vial Y, Favrod C, Harari MM, Blackwell SE, Watson P, Iyadurai L, Bonsall MB, Holmes EA. Reducing intrusive traumatic memories after emergency caesarean section: A proof-of-principle randomized controlled study. Behav Res Ther. 2017 Jul;94:36-47. doi: 10.1016/j.brat.2017.03.018. Epub 2017 Apr 6.

  PMID: 28453969 BACKGROUND

• Deforges C, Sandoz V, Noel Y, Avignon V, Desseauve D, Bourdin J, Vial Y, Ayers S, Holmes EA, Epiney M, Horsch A. Single-session visuospatial task procedure to prevent childbirth-related posttraumatic stress disorder: a multicentre double-blind randomised controlled trial. Mol Psychiatry. 2023 Sep;28(9):3842-3850. doi: 10.1038/s41380-023-02275-w. Epub 2023 Sep 27.

  PMID: 37759037 DERIVED

• Sandoz V, Deforges C, Stuijfzand S, Epiney M, Vial Y, Sekarski N, Messerli-Burgy N, Ehlert U, Bickle-Graz M, Morisod Harari M, Porcheret K, Schechter DS, Ayers S, Holmes EA, Horsch A; START Research Consortium. Improving mental health and physiological stress responses in mothers following traumatic childbirth and in their infants: study protocol for the Swiss TrAumatic biRth Trial (START). BMJ Open. 2019 Dec 30;9(12):e032469. doi: 10.1136/bmjopen-2019-032469.

  PMID: 31892657 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Stress Disorders, Traumatic, Acute

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Antje Horsch, D.Clin.Psych.

  University of Lausanne and Lausanne University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 4, 2018
• First Posted: July 3, 2018
• Study Start: August 2, 2018
• Primary Completion: December 15, 2021
• Study Completion: February 8, 2022
• Last Updated: August 17, 2022

Record last verified: 2022-08

Locations

CH (1)