Evidence map›Paper›PMID 37759037›Full record

Trial reportMolecular psychiatry2023

Single-session visuospatial task procedure to prevent childbirth-related posttraumatic stress disorder: a multicentre double-blind randomised controlled trial.

Camille Deforges, Vania Sandoz, Yvonnick Noël, Valérie Avignon, David Desseauve, Julie Bourdin, Yvan Vial, Susan Ayers, Emily A Holmes, Manuella Epiney and 1 more

Registry-linked trialAbstract readRandomized Controlled TrialMulticenter StudyEquivalence Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Molecular psychiatry, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03576586 (Improving Mental Health and Physiological Stress Responses in Mothers Following Traumatic Childbirth and in Their Infants), which is not on this map. Cited by 9 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 2 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03576586 nacompletednot on this map

Improving Mental Health and Physiological Stress Responses in Mothers Following Traumatic Childbirth and in Their Infants: a Randomised Controlled Trial (START)

TypeinterventionalSponsorCentre Hospitalier Universitaire VaudoisRan2018 to 2022Enrolled147ConditionsPosttraumatic Stress Disorder, Acute Stress DisorderArmsBrief computerized intervention, Attention placebo control
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Article
  6. Review
  7. Article
  8. Article
  9. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Camille Deforges *Institute of Higher Education and Research in Healthcare, University of Lausanne, Lausanne, Vaud, Switzerland.
Vania Sandoz *Institute of Higher Education and Research in Healthcare, University of Lausanne, Lausanne, Vaud, Switzerland.ORCID 0000-0002-2763-667X
Yvonnick NoëlDepartment of Psychology, Rennes 2 University, Rennes, France.
Valérie AvignonInstitute of Higher Education and Research in Healthcare, University of Lausanne, Lausanne, Vaud, Switzerland.
David DesseauveDepartment Woman-Mother-Child, Lausanne University Hospital, Lausanne, Vaud, Switzerland.
Julie BourdinDepartment Woman-Mother-Child, Lausanne University Hospital, Lausanne, Vaud, Switzerland.
Yvan VialDepartment Woman-Mother-Child, Lausanne University Hospital, Lausanne, Vaud, Switzerland.
Susan AyersCentre for Maternal and Child Health Research, City, University of London, London, UK.
Emily A HolmesDepartment of Psychology, Uppsala University, Uppsala, Sweden.ORCID 0000-0001-7319-3112
Manuella EpineyDepartment of Woman, Child and Teenager, Geneva University Hospitals, Geneva, Switzerland.
Antje HorschInstitute of Higher Education and Research in Healthcare, University of Lausanne, Lausanne, Vaud, Switzerland. antje.horsch@chuv.ch.ORCID 0000-0002-9950-9661

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Preventive evidence-based interventions for childbirth-related posttraumatic stress disorder (CB-PTSD) are lacking. Yet, 18.5% of women develop CB-PTSD symptoms following an unplanned caesarean section (UCS). This two-arm, multicentre, double-blind superiority trial tested the efficacy of an early single-session intervention including a visuospatial task on the prevention of maternal CB-PTSD symptoms. The intervention was delivered by trained maternity clinicians. Shortly after UCS, women were included if they gave birth to a live baby, provided consent, and perceived their childbirth as traumatic. Participants were randomly assigned to the intervention or attention-placebo group (allocation ratio 1:1). Assessments were done at birth, six weeks, and six months postpartum. Group differences in maternal CB-PTSD symptoms at six weeks (primary outcomes) and six months postpartum (secondary outcomes) were assessed with the self-report PTSD Checklist for DSM-5 (PCL-5) and by blinded research assessors with the Clinician-administered PTSD scale for DSM-5 (CAPS-5). Analysis was by intention-to-treat. The trial was prospectively registered (ClinicalTrials.gov, NCT03576586). Of the 2068 women assessed for eligibility, 166 were eligible and 146 were randomly assigned to the intervention (n = 74) or attention-placebo control group (n = 72). For the PCL-5, at six weeks, a marginally significant intervention effect was found on the total PCL-5 PTSD symptom count (β = -0.43, S.E. = 0.23, z = -1.88, p < 0.06), and on the intrusions (β = -0.73, S.E. = 0.38, z = -1.94, p < 0.0525) and arousal (β = -0.55, S.E. = 0.29, z = -1.92, p < 0.0552) clusters. At six months, a significant intervention effect on the total PCL-5 PTSD symptom count (β = -0.65, S.E. = 0.32, z = -2.04, p = 0.041, 95%CI[-1.27, -0.03]), on alterations in cognition and mood (β = -0.85, S.E. = 0.27, z = -3.15, p = 0.0016) and arousal (β = -0.56, S.E. = 0.26, z = -2.19, p < 0.0289, 95%CI[-1.07, -0.06]) clusters appeared. No group differences on the CAPS-5 emerged. Results provide evidence that this brief, single-session intervention carried out by trained clinicians can prevent the development of CB-PTSD symptoms up to six months postpartum.

Indexed as

Cesarean SectionStress Disorders, Post-TraumaticAffectDouble-Blind MethodEarly Intervention, EducationalFemaleHumansInfant, NewbornPregnancyTreatment Outcome

Identifiers

PMID37759037
PMCPMC10730415

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.