Utility of early, short psychological care for women who experience early miscarriage: protocol for the randomized, controlled MisTher trial.
Anxiety
Depression
Early miscarriage
Post-traumatic stress disorder
Psychological care
Journal
BMC psychology
ISSN: 2050-7283
Titre abrégé: BMC Psychol
Pays: England
ID NLM: 101627676
Informations de publication
Date de publication:
03 Nov 2023
03 Nov 2023
Historique:
received:
20
09
2023
accepted:
31
10
2023
medline:
6
11
2023
pubmed:
4
11
2023
entrez:
4
11
2023
Statut:
epublish
Résumé
Around one in ten women will have a miscarriage in their lifetime. Miscarriage is often considered a trivial event by caregivers, but it is associated with a high burden of psychological morbidity, especially during the first 6 months. There is no validated psychological management strategy for women who have had a miscarriage. The MisTher study aims to evaluate the utility of early, short psychological care for women who have had early miscarriage, in terms of anxiety, depression and post-traumatic stress disorder. This is a prospective, multicenter, randomized, controlled, superiority study. In total, 932 women who have experienced early miscarriage (spontaneous interruption of pregnancy prior to 14 weeks of gestation) will be randomly assigned to either the intervention or the control group. The intervention consists of 4 teleconsultations of 45 min with a psychologist. All women, regardless of their allocated group, will be encouraged to seek an early consultation with a general practitioner or midwife. The primary endpoint will be anxiety at 3 months after randomization evaluated using State Trait Anxiety Inventory. The secondary endpoints will be anxiety at 6 months evaluated using State Trait Anxiety Inventory, depression at 3 and 6 months evaluated with the Beck Depression Inventory, and post-traumatic stress disorder at 3 and 6 months, evaluated using the Posttraumatic stress disorder Checklist Scale. This project will validate the importance of early psychological management, based on primary care and accessible to most women, via teleconsultation, in reducing the frequency of psychological disorders after early miscarriage. Our results should provide a basis for new recommendations for the management of women who have experienced miscarriage, notably by recommending the involvement of trained psychologists in the management pathway for these women. The trial is registered with ClinicalTrials.gov: NCT05653414. December 15th, 2022.
Sections du résumé
BACKGROUND
BACKGROUND
Around one in ten women will have a miscarriage in their lifetime. Miscarriage is often considered a trivial event by caregivers, but it is associated with a high burden of psychological morbidity, especially during the first 6 months. There is no validated psychological management strategy for women who have had a miscarriage. The MisTher study aims to evaluate the utility of early, short psychological care for women who have had early miscarriage, in terms of anxiety, depression and post-traumatic stress disorder.
METHODS
METHODS
This is a prospective, multicenter, randomized, controlled, superiority study. In total, 932 women who have experienced early miscarriage (spontaneous interruption of pregnancy prior to 14 weeks of gestation) will be randomly assigned to either the intervention or the control group. The intervention consists of 4 teleconsultations of 45 min with a psychologist. All women, regardless of their allocated group, will be encouraged to seek an early consultation with a general practitioner or midwife. The primary endpoint will be anxiety at 3 months after randomization evaluated using State Trait Anxiety Inventory. The secondary endpoints will be anxiety at 6 months evaluated using State Trait Anxiety Inventory, depression at 3 and 6 months evaluated with the Beck Depression Inventory, and post-traumatic stress disorder at 3 and 6 months, evaluated using the Posttraumatic stress disorder Checklist Scale.
DISCUSSION
CONCLUSIONS
This project will validate the importance of early psychological management, based on primary care and accessible to most women, via teleconsultation, in reducing the frequency of psychological disorders after early miscarriage. Our results should provide a basis for new recommendations for the management of women who have experienced miscarriage, notably by recommending the involvement of trained psychologists in the management pathway for these women.
TRIAL REGISTRATION
BACKGROUND
The trial is registered with ClinicalTrials.gov: NCT05653414. December 15th, 2022.
Identifiants
pubmed: 37924101
doi: 10.1186/s40359-023-01421-x
pii: 10.1186/s40359-023-01421-x
pmc: PMC10625184
doi:
Banques de données
ClinicalTrials.gov
['NCT05653414']
Types de publication
Clinical Trial Protocol
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
368Informations de copyright
© 2023. The Author(s).
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