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Posttraumatic Stress Disorder and Neuroprogression in Women Following Sexual Assault: Protocol for a Randomized Clinical Trial Evaluating Allostatic Load and Aging Process Acceleration

BACKGROUND: Posttraumatic stress disorder (PTSD) is a prevalent, chronic, and severe disorder related to traumatic events. Women are disproportionately affected by PTSD than men and are more at risk in the occurrence of sexual assault victimization. Estimates suggest that 50% of women develop PTSD f...

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Autores principales: Coimbra, Bruno Messina, Yeh, Mary, D'Elia, Ana Teresa, Maciel, Mariana Rangel, Carvalho, Carolina Muniz, Milani, Ana Carolina, Mozzambani, Adriana, Juruena, Mario, Belangero, Sintia Iole, Jackowski, Andrea Parolin, Poyares, Dalva, Mello, Andrea Feijo, Mello, Marcelo Feijo
Formato: Online Artículo Texto
Lenguaje:English
Publicado: JMIR Publications 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7710442/
https://www.ncbi.nlm.nih.gov/pubmed/33206061
http://dx.doi.org/10.2196/19162
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author Coimbra, Bruno Messina
Yeh, Mary
D'Elia, Ana Teresa
Maciel, Mariana Rangel
Carvalho, Carolina Muniz
Milani, Ana Carolina
Mozzambani, Adriana
Juruena, Mario
Belangero, Sintia Iole
Jackowski, Andrea Parolin
Poyares, Dalva
Mello, Andrea Feijo
Mello, Marcelo Feijo
author_facet Coimbra, Bruno Messina
Yeh, Mary
D'Elia, Ana Teresa
Maciel, Mariana Rangel
Carvalho, Carolina Muniz
Milani, Ana Carolina
Mozzambani, Adriana
Juruena, Mario
Belangero, Sintia Iole
Jackowski, Andrea Parolin
Poyares, Dalva
Mello, Andrea Feijo
Mello, Marcelo Feijo
author_sort Coimbra, Bruno Messina
collection PubMed
description BACKGROUND: Posttraumatic stress disorder (PTSD) is a prevalent, chronic, and severe disorder related to traumatic events. Women are disproportionately affected by PTSD than men and are more at risk in the occurrence of sexual assault victimization. Estimates suggest that 50% of women develop PTSD following sexual assault and successful clinical management can be challenging. Growing evidence has implicated neural, immune, and endocrine alterations underpinning PTSD, but only few studies have assessed the evolution of acute PTSD in women. OBJECTIVE: This study aims to measure whether the onset of PTSD is associated with accelerated aging in women following sexual assault. We hypothesize that the increase of allostatic load caused by PTSD leads to neuroprogression. We will implement a randomized clinical trial to compare responses to treatment with either interpersonal psychotherapy adapted for PTSD (IPT-PTSD) or the selective serotonin reuptake inhibitor sertraline. METHODS: We will include women between 18 and 45 years of age, who experienced sexual assault from 1 to 6 months before the initial evaluation, and present with a Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5) diagnosis of PTSD. Baseline evaluation will comprise clinical and psychometric assessments, structural and functional magnetic resonance imaging, neuropsychological testing, polysomnography, evaluation of immune and endocrine parameters, and genetic analyses. Age-matched female healthy controls will be included and subjected to the same evaluation. Patients will be randomized for treatment in 1 of the 2 arms of the study for 14 weeks; follow-up will continue until 1 year after inclusion via treatment as usual. The researchers will collect clinical and laboratory data during periodic clinical assessments up to 1-year follow-up. RESULTS: Data collection started in early 2016 and will be completed by the end of the first semester of 2020. Analyses will be performed soon afterward, followed by the elaboration of several articles. Articles will be submitted in early 2021. This research project has obtained a grant from the Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP 2014/12559-5). CONCLUSIONS: We expect to provide insight into the consequences of recent sexual assault exposure in women by investigating the degree of neuroprogression developing from an early stage of PTSD. We also expect to provide important evidence on the efficacy of a non-exposure psychotherapy (IPT-PTSD) to mitigate PTSD symptoms in recently sexually assaulted women. Further, we aim to obtain evidence on how treatment outcomes are associated with neuroprogression measures. TRIAL REGISTRATION: Brazilian Clinical Trials Registry RBR-3z474z; http://www.ensaiosclinicos.gov.br/rg/RBR-3z474z/ INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/19162
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spelling pubmed-77104422020-12-30 Posttraumatic Stress Disorder and Neuroprogression in Women Following Sexual Assault: Protocol for a Randomized Clinical Trial Evaluating Allostatic Load and Aging Process Acceleration Coimbra, Bruno Messina Yeh, Mary D'Elia, Ana Teresa Maciel, Mariana Rangel Carvalho, Carolina Muniz Milani, Ana Carolina Mozzambani, Adriana Juruena, Mario Belangero, Sintia Iole Jackowski, Andrea Parolin Poyares, Dalva Mello, Andrea Feijo Mello, Marcelo Feijo JMIR Res Protoc Protocol BACKGROUND: Posttraumatic stress disorder (PTSD) is a prevalent, chronic, and severe disorder related to traumatic events. Women are disproportionately affected by PTSD than men and are more at risk in the occurrence of sexual assault victimization. Estimates suggest that 50% of women develop PTSD following sexual assault and successful clinical management can be challenging. Growing evidence has implicated neural, immune, and endocrine alterations underpinning PTSD, but only few studies have assessed the evolution of acute PTSD in women. OBJECTIVE: This study aims to measure whether the onset of PTSD is associated with accelerated aging in women following sexual assault. We hypothesize that the increase of allostatic load caused by PTSD leads to neuroprogression. We will implement a randomized clinical trial to compare responses to treatment with either interpersonal psychotherapy adapted for PTSD (IPT-PTSD) or the selective serotonin reuptake inhibitor sertraline. METHODS: We will include women between 18 and 45 years of age, who experienced sexual assault from 1 to 6 months before the initial evaluation, and present with a Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5) diagnosis of PTSD. Baseline evaluation will comprise clinical and psychometric assessments, structural and functional magnetic resonance imaging, neuropsychological testing, polysomnography, evaluation of immune and endocrine parameters, and genetic analyses. Age-matched female healthy controls will be included and subjected to the same evaluation. Patients will be randomized for treatment in 1 of the 2 arms of the study for 14 weeks; follow-up will continue until 1 year after inclusion via treatment as usual. The researchers will collect clinical and laboratory data during periodic clinical assessments up to 1-year follow-up. RESULTS: Data collection started in early 2016 and will be completed by the end of the first semester of 2020. Analyses will be performed soon afterward, followed by the elaboration of several articles. Articles will be submitted in early 2021. This research project has obtained a grant from the Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP 2014/12559-5). CONCLUSIONS: We expect to provide insight into the consequences of recent sexual assault exposure in women by investigating the degree of neuroprogression developing from an early stage of PTSD. We also expect to provide important evidence on the efficacy of a non-exposure psychotherapy (IPT-PTSD) to mitigate PTSD symptoms in recently sexually assaulted women. Further, we aim to obtain evidence on how treatment outcomes are associated with neuroprogression measures. TRIAL REGISTRATION: Brazilian Clinical Trials Registry RBR-3z474z; http://www.ensaiosclinicos.gov.br/rg/RBR-3z474z/ INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/19162 JMIR Publications 2020-11-18 /pmc/articles/PMC7710442/ /pubmed/33206061 http://dx.doi.org/10.2196/19162 Text en ©Bruno Messina Coimbra, Mary Yeh, Ana Teresa D'Elia, Mariana Rangel Maciel, Carolina Muniz Carvalho, Ana Carolina Milani, Adriana Mozzambani, Mario Juruena, Sintia Iole Belangero, Andrea Parolin Jackowski, Dalva Poyares, Andrea Feijo Mello, Marcelo Feijo Mello. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 18.11.2020. https://creativecommons.org/licenses/by/4.0/ This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on http://www.researchprotocols.org, as well as this copyright and license information must be included.
spellingShingle Protocol
Coimbra, Bruno Messina
Yeh, Mary
D'Elia, Ana Teresa
Maciel, Mariana Rangel
Carvalho, Carolina Muniz
Milani, Ana Carolina
Mozzambani, Adriana
Juruena, Mario
Belangero, Sintia Iole
Jackowski, Andrea Parolin
Poyares, Dalva
Mello, Andrea Feijo
Mello, Marcelo Feijo
Posttraumatic Stress Disorder and Neuroprogression in Women Following Sexual Assault: Protocol for a Randomized Clinical Trial Evaluating Allostatic Load and Aging Process Acceleration
title Posttraumatic Stress Disorder and Neuroprogression in Women Following Sexual Assault: Protocol for a Randomized Clinical Trial Evaluating Allostatic Load and Aging Process Acceleration
title_full Posttraumatic Stress Disorder and Neuroprogression in Women Following Sexual Assault: Protocol for a Randomized Clinical Trial Evaluating Allostatic Load and Aging Process Acceleration
title_fullStr Posttraumatic Stress Disorder and Neuroprogression in Women Following Sexual Assault: Protocol for a Randomized Clinical Trial Evaluating Allostatic Load and Aging Process Acceleration
title_full_unstemmed Posttraumatic Stress Disorder and Neuroprogression in Women Following Sexual Assault: Protocol for a Randomized Clinical Trial Evaluating Allostatic Load and Aging Process Acceleration
title_short Posttraumatic Stress Disorder and Neuroprogression in Women Following Sexual Assault: Protocol for a Randomized Clinical Trial Evaluating Allostatic Load and Aging Process Acceleration
title_sort posttraumatic stress disorder and neuroprogression in women following sexual assault: protocol for a randomized clinical trial evaluating allostatic load and aging process acceleration
topic Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7710442/
https://www.ncbi.nlm.nih.gov/pubmed/33206061
http://dx.doi.org/10.2196/19162
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