Utility of early, short psychological care for women who experience early miscarriage: protocol for the randomized, controlled MisTher trial
Abstract 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 manageme...
| Main Authors: | , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2023-11-01
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| Series: | BMC Psychology |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s40359-023-01421-x |
| _version_ | 1797636639206408192 |
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| author | Coralie Barbe Marie Boiteux-Chabrier Emilie Charillon Leïla Bouazzi Chloe Maheas Fadela Merabet Olivier Graesslin Julie Auer Sabrina Hammami Anne-Catherine Rolland Aline Hurtaud |
| author_facet | Coralie Barbe Marie Boiteux-Chabrier Emilie Charillon Leïla Bouazzi Chloe Maheas Fadela Merabet Olivier Graesslin Julie Auer Sabrina Hammami Anne-Catherine Rolland Aline Hurtaud |
| author_sort | Coralie Barbe |
| collection | DOAJ |
| description | Abstract 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 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 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 The trial is registered with ClinicalTrials.gov: NCT05653414. December 15th, 2022. |
| first_indexed | 2024-03-11T12:36:55Z |
| format | Article |
| id | doaj.art-bc4db6b2ef08427294ab7bebe2e9aa9a |
| institution | Directory Open Access Journal |
| issn | 2050-7283 |
| language | English |
| last_indexed | 2024-03-11T12:36:55Z |
| publishDate | 2023-11-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Psychology |
| spelling | doaj.art-bc4db6b2ef08427294ab7bebe2e9aa9a2023-11-05T12:32:48ZengBMCBMC Psychology2050-72832023-11-011111810.1186/s40359-023-01421-xUtility of early, short psychological care for women who experience early miscarriage: protocol for the randomized, controlled MisTher trialCoralie Barbe0Marie Boiteux-Chabrier1Emilie Charillon2Leïla Bouazzi3Chloe Maheas4Fadela Merabet5Olivier Graesslin6Julie Auer7Sabrina Hammami8Anne-Catherine Rolland9Aline Hurtaud10Comité Universitaire de Ressources pour la Recherche en Santé, Université de Reims Champagne-Ardenne, UFR MédecineDépartement de Médecine Générale, Université de Reims Champagne-Ardenne, UFR MédecineComité Universitaire de Ressources pour la Recherche en Santé, Université de Reims Champagne-Ardenne, UFR MédecineComité Universitaire de Ressources pour la Recherche en Santé, Université de Reims Champagne-Ardenne, UFR MédecineComité Universitaire de Ressources pour la Recherche en Santé, Université de Reims Champagne-Ardenne, UFR MédecineUFR MédecineService de Gynécologie et d’Obstétrique, Centre Hospitalier Universitaire de ReimsService de Psychothérapie de l’enfant et de l’adolescent, Pôle Femme-Parents-Enfant, Centre Hospitalier Universitaire de ReimsLaboratoire C2S (Cognition, Santé, Société), EA6291, Université de Reims Champagne ArdenneLaboratoire C2S (Cognition, Santé, Société), EA6291, Université de Reims Champagne ArdenneDépartement de Médecine Générale, Université de Reims Champagne-Ardenne, UFR MédecineAbstract 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 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 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 The trial is registered with ClinicalTrials.gov: NCT05653414. December 15th, 2022.https://doi.org/10.1186/s40359-023-01421-xEarly miscarriagePsychological careAnxietyDepressionPost-traumatic stress disorder |
| spellingShingle | Coralie Barbe Marie Boiteux-Chabrier Emilie Charillon Leïla Bouazzi Chloe Maheas Fadela Merabet Olivier Graesslin Julie Auer Sabrina Hammami Anne-Catherine Rolland Aline Hurtaud Utility of early, short psychological care for women who experience early miscarriage: protocol for the randomized, controlled MisTher trial BMC Psychology Early miscarriage Psychological care Anxiety Depression Post-traumatic stress disorder |
| title | Utility of early, short psychological care for women who experience early miscarriage: protocol for the randomized, controlled MisTher trial |
| title_full | Utility of early, short psychological care for women who experience early miscarriage: protocol for the randomized, controlled MisTher trial |
| title_fullStr | Utility of early, short psychological care for women who experience early miscarriage: protocol for the randomized, controlled MisTher trial |
| title_full_unstemmed | Utility of early, short psychological care for women who experience early miscarriage: protocol for the randomized, controlled MisTher trial |
| title_short | Utility of early, short psychological care for women who experience early miscarriage: protocol for the randomized, controlled MisTher trial |
| title_sort | utility of early short psychological care for women who experience early miscarriage protocol for the randomized controlled misther trial |
| topic | Early miscarriage Psychological care Anxiety Depression Post-traumatic stress disorder |
| url | https://doi.org/10.1186/s40359-023-01421-x |
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