The Library
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
Tools
Moran, Paul, Bick, Debra, Biddle, Lucy, Borries, Belinda, Kandiyali, Rebecca, Rigby, Janice, Seume, Penny, Sadhnani, Vaneeta, Smith, Nadine, Swales, Michaela A. and Turner, Nicholas (2022) 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. Pilot and Feasibility Studies, 8 (1). 215. doi:10.1186/s40814-022-01177-y ISSN 2055-5784.
|
PDF
WRAP-A-feasibility-randomised-controlled-trial-with-an-embedded-qualitative-evaluation-of-perinatal-emotional-skills-groups-for-women-with-borderline-personality-disorder-2022.pdf - Published Version - Requires a PDF viewer. Available under License Creative Commons Attribution 4.0. Download (1942Kb) | Preview |
Official URL: http://dx.doi.org/10.1186/s40814-022-01177-y
Abstract
Background
Borderline 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.
Methods
A 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 registration
ISRCTN80470632.
Item Type: | Journal Article | ||||||||
---|---|---|---|---|---|---|---|---|---|
Subjects: | R Medicine > RC Internal medicine R Medicine > RG Gynecology and obstetrics |
||||||||
Divisions: | Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Clinical Trials Unit Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School |
||||||||
Library of Congress Subject Headings (LCSH): | Borderline personality disorder , Pregnant women -- Mental health, Mental illness in pregnancy | ||||||||
Journal or Publication Title: | Pilot and Feasibility Studies | ||||||||
Publisher: | BioMed Central Ltd. | ||||||||
ISSN: | 2055-5784 | ||||||||
Official Date: | 23 September 2022 | ||||||||
Dates: |
|
||||||||
Volume: | 8 | ||||||||
Number: | 1 | ||||||||
Number of Pages: | 13 | ||||||||
Article Number: | 215 | ||||||||
DOI: | 10.1186/s40814-022-01177-y | ||||||||
Status: | Peer Reviewed | ||||||||
Publication Status: | Published | ||||||||
Access rights to Published version: | Open Access (Creative Commons) | ||||||||
Date of first compliant deposit: | 10 October 2022 | ||||||||
Date of first compliant Open Access: | 11 October 2022 | ||||||||
RIOXX Funder/Project Grant: |
|
Request changes or add full text files to a record
Repository staff actions (login required)
View Item |
Downloads
Downloads per month over past year