Evidence map›Paper›PMID 39438931›Full record

ArticleTrials2024

RELAX (REducing Levels of AnXiety): a study protocol for a parallel two-arm randomised controlled trial evaluating a web-based early intervention for pregnant women with high levels of repetitive negative thinking to prevent escalating anxiety during pregnancy and after birth.

Brittannia Volkmer, Yogini Sawjani, Mary Newburn, Jo Bennett, Megan McGovern, Laura Bridle, Nathalie Towner, Laura McCabe, Katherine Clark, Sophie Webster and 8 more

Abstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Trial
  2. 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

18 authors.

Brittannia VolkmerInstitute of Psychiatry, Psychology and Neuroscience, King's College London, De Crespigny Park, London, UK.ORCID http://orcid.org/0009-0000-1046-3912
Yogini SawjaniInstitute of Psychiatry, Psychology and Neuroscience, King's College London, De Crespigny Park, London, UK.
Mary NewburnInstitute of Psychiatry, Psychology and Neuroscience, King's College London, De Crespigny Park, London, UK.
Jo BennettInstitute of Psychiatry, Psychology and Neuroscience, King's College London, De Crespigny Park, London, UK.
Megan McGovernDepartment of Biostatistics & Health Informatics, Institute of Psychiatry, Psychology and Neuroscience, King's College London, De Crespigny Park, London, UK.
Laura BridleKing's College Hospital NHS Foundation Trust, Denmark Hill, London, UK.
Nathalie TownerInstitute of Psychiatry, Psychology and Neuroscience, King's College London, De Crespigny Park, London, UK.
Laura McCabeDepartment of Women's and Children's Health, Guy's and St Thomas' NHS Foundation Trust, c/o, North Wing, St Thomas' Hospital, 10 Floor Lambeth Palace Road, London, UK.
Katherine ClarkKing's College Hospital NHS Foundation Trust, Denmark Hill, London, UK.
Sophie WebsterKing's College Hospital NHS Foundation Trust, Denmark Hill, London, UK.
Alison Hylton-PottsEpsom and St Helier University Hospitals NHS Trust, Wrythe Lane, London, UK.
Lucy MayerMid Cheshire Hospitals NHS Foundation Trust, C/O Leighton Hospital, Middlewich Road, Crewe, UK.
Gertrude SeneviranteSouth London and Maudsley NHS Foundation Trust, Maudsley Hospital, Denmark Hill, London, UK.
Debra BickWarwick Clinical Trials Unit, Warwick Medical School, Warwick, UK.
Jill NewbyBlack Dog Institute, Randwick, Australia.
Kimberley GoldsmithDepartment of Biostatistics & Health Informatics, Institute of Psychiatry, Psychology and Neuroscience, King's College London, De Crespigny Park, London, UK.
Michelle L MouldsSchool of Psychology, Faculty of Science, UNSW Sydney, Kensington, Australia.
Colette HirschInstitute of Psychiatry, Psychology and Neuroscience, King's College London, De Crespigny Park, London, UK. colette.hirsch@kcl.ac.uk.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPerinatal anxiety is common: up to 40% of pregnant women and new mothers experience high levels of anxiety. Given its prevalence, interventions that are low-intensity, highly accessible and cost-efficient, and target modifiable risk factors for anxiety are needed. Repetitive negative thinking (RNT)-such as worrying about ways things will go wrong in the future or ruminating about past negative events-is a risk factor for the development of anxiety. RNT is maintained by the tendency to generate negative interpretations of ambiguous situations.

methodsA parallel two-arm randomised controlled trial will assess the efficacy of adding interpretation training (RELAX) to usual maternity care. Participants (N = 268) will be randomised to (i) 12 sessions of online interpretation training (RELAX) plus usual care, or (ii) usual care alone. We will assess anxiety, depression, RNT, and work and social adjustment at baseline, plus 4, 8 and 36 weeks later. DISCUSSION: Should the intervention result in lower levels of anxiety than usual care, it could be an accessible, cost-effective way to help women who are vulnerable to experiencing anxiety in the perinatal period.

trial registrationISRCTN 12754931. Registered 25th May 2023, prior to recruitment.

Indexed as

AnxietyInternet-Based InterventionNegativismParturitionPregnant PeopleRandomized Controlled Trials as TopicAdultFemaleHumansPregnancyPregnancy ComplicationsTime FactorsTreatment OutcomeAnxietyCognitive bias modification (CBM)Digital therapyPerinatal mental healthPregnancyPreventionRepetitive negative thinking (RNT)

Identifiers

PMID39438931
PMCPMC11515756

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Registered trials

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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.