RAPID-2 study protocol: a cluster randomised feasibility trial of a midwife facilitated intervention for pregnant women with symptoms of mild to moderate anxiety.
clinical trials
mental health
obstetrics
Journal
BMJ open
ISSN: 2044-6055
Titre abrégé: BMJ Open
Pays: England
ID NLM: 101552874
Informations de publication
Date de publication:
26 10 2022
26 10 2022
Historique:
entrez:
26
10
2022
pubmed:
27
10
2022
medline:
29
10
2022
Statut:
epublish
Résumé
Many women experience symptoms during pregnancy. Elevated and prolonged anxiety can have negative effects on the woman and baby. The RAPID intervention aims to provide suitable, timely support for women with mild-moderate anxiety. The RAPID intervention is based on social support, relational continuity, psychological and relaxation response theory, and comprises midwife facilitated group discussions, one-to-one support and directed self-help materials. Four National Health Service Trusts in England that provide maternity care will be cluster randomised to the RAPID intervention plus usual care or usual care. At each intervention site, two midwives and two maternity support workers will facilitate the intervention over a 12-week period. Eligibility includes nulliparous women at 16-20 weeks of pregnancy (n=50) with self-report symptoms of mild-moderate anxiety. Community midwives will signpost women to the study. The aim of the study is to establish the feasibility of conducting a definitive trial to examine the effectiveness of the RAPID intervention in addition to usual care. The objectives are to assess recruitment and completion rates, and a qualitative assessment of women's and facilitators' experiences of participation. An estimation of change in the seven-item Generalised Anxiety Disorder scale will inform the sample size for a definitive cluster trial. Ethical approval was given by East Midlands-Derby Research Ethics Committee 14 March 2022 (REC Reference: 22/EM/0018). Findings will be made available through publication in peer-reviewed journals, conferences and to participants. A final report will be submitted to HEE/NIHR ICA awards committee for publication. ISRCTN12834758.
Identifiants
pubmed: 36288833
pii: bmjopen-2022-064659
doi: 10.1136/bmjopen-2022-064659
pmc: PMC9615978
doi:
Banques de données
ISRCTN
['ISRCTN12834758']
Types de publication
Clinical Trial Protocol
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
e064659Informations de copyright
© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
Déclaration de conflit d'intérêts
Competing interests: None declared.
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