Evidence map›Paper›PMID 36151584›Full record

ArticlePilot and feasibility studies2022

A feasibility randomised controlled trial with an embedded qualitative evaluation of perinatal emotional skills groups for women with borderline personality disorder: protocol for the EASE study.

Paul Moran, Debra Bick, Lucy Biddle, Belinda Borries, Rebecca Kandiyali, Janice Rigby, Penny Seume, Vaneeta Sadhnani, Nadine Smith, Michaela Swales and 1 more

Open access · goldAbstract read
In one paragraph

Article in Pilot and feasibility studies, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.4field-weighted citation impact, top 37% of its field
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

3 citing papers in PubMed, 2 citations in OpenAlex.

  1. Article
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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 at 6 institutions in 1 country.

Paul MoranCentre for Academic Mental Health, Population Health Sciences Department, Bristol Medical School, University of Bristol, Bristol, UK. paul.moran@bristol.ac.uk.ORCID http://orcid.org/0000-0002-9257-8699
Debra BickWarwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.
Lucy BiddlePopulation Health Sciences Department, Bristol Medical School, University of Bristol, Bristol, UK.
Belinda BorriesSpecialist Community Perinatal Mental Health Service, Avon & Wiltshire Mental Health Partnership NHS Trust, Bristol, UK.
Rebecca KandiyaliCentre for Health Economics, Warwick Clinical Trials Unit, University of Warwick, Coventry, UK.
Janice RigbyChanni Kumar Mother and Baby Unit, Bethlem Royal Hospital, South London and Maudsley NHS Foundation Trust, London, UK.
Penny SeumeCentre for Academic Mental Health, Population Health Sciences Department, Bristol Medical School, University of Bristol, Bristol, UK.
Vaneeta SadhnaniSpecialist Community Perinatal Mental Health Service, Avon & Wiltshire Mental Health Partnership NHS Trust, Bristol, UK.
Nadine SmithPatient and Public Involvement and Engagement Lead, London, UK.
Michaela SwalesNorth Wales Clinical psychology Programme, Bangor University, Bath, UK.
Nicholas TurnerPopulation Health Sciences Department, Bristol Medical School, University of Bristol, Bristol, UK.
University of Bristol · GBAvon and Wiltshire Mental Health Partnership NHS Trust · GBUniversity of Warwick · GBAt Bristol · GBBangor University · GBSouth London and Maudsley NHS Foundation Trust · GB

Funding

Research for Patient Benefit Programme NIHR202165
6 · The paper itself

Abstract

backgroundBorderline personality disorder (BPD) is a severe mental disorder characterised by emotional instability, impaired interpersonal functioning and an increased risk of suicide. There is no clear evidence about how best to help women with BPD during the perinatal period. Perinatal Emotional Skills Groups (ESGs) consist of 12 group sessions, focussing on core skills in emotion regulation, interpersonal effectiveness, distress tolerance and mindfulness and how these skills can best be utilised during the perinatal period. Prior observational research has shown that perinatal ESGs may help women with BPD. We set out to test the feasibility of conducting a randomised controlled trial to investigate the clinical effectiveness of perinatal ESGs.

methodsA two-arm, parallel-group, feasibility randomised controlled trial of Perinatal ESGs in addition to Treatment as Usual (TAU) versus TAU for women aged over 18 years, who are likely to have a diagnosis of BPD and are either pregnant or are within 12 months of having a live birth. We will exclude women who have a co-existing organic, psychotic mental disorder or substance use dependence syndrome; those with cognitive or language difficulties that would preclude them from consenting or participating in study procedures; those judged to pose an acute risk to their baby and those requiring admission to a mother and baby unit. After consenting to participation and completing screening assessments, eligible individuals will be randomly allocated, on a 1:1 ratio, to either ESGs + TAU or to TAU. Randomisation will be stratified according to recruitment centre. Feasibility outcomes will be the proportion of participants: (1) consenting; (2) completing baseline measures and randomised; (3) completing the intervention and (4) completing follow-up assessments. All study participants will complete a battery of self-report measures at 2 and 4 months post-randomisation. A nested qualitative study will examine participants' and therapists' experiences of the trial and the intervention. DISCUSSION: Evidence is lacking about how to help women with BPD during the perinatal period. Perinatal ESGs are a promising intervention and if they prove to be an effective adjunct to usual care, a large population of vulnerable women and their children could experience substantial health gains.

trial registrationISRCTN80470632.

Indexed as

Borderline personality disorderClinical trialPerinatal mental healthPsychological treatmentQualitative study

Identifiers

PMID36151584
PMCPMC9503265
OpenAlexW4297004388

What OpenQuestion holds

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LicenceCC BY
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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.