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Coimbra BM, Yeh M, D'Elia AT, Maciel MR, Carvalho CM, Milani AC, Mozzambani A, Juruena M, Belangero SI, Jackowski AP, Poyares D, Mello AF, Mello MF
Posttraumatic Stress Disorder and Neuroprogression in Women Following Sexual Assault: Protocol for a Randomized Clinical Trial Evaluating Allostatic Load and Aging Process Acceleration
Posttraumatic Stress Disorder and Neuroprogression: study protocol of allostatic load and aging process acceleration in a randomized clinical trial for women following sexual assault
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
ABSTRACT
Background:
Posttraumatic stress disorder (PTSD) is a prevalent, chronic, and severe disorder related to traumatic events. Growing evidence has implicated neural, immune, and endocrine alterations underpinning PTSD, but few studies have assessed the evolution of acute PTSD in women.
Objective:
The present 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. A randomized controlled trial will also be performed to compare responses to treatment with either interpersonal psychotherapy adapted for PTSD or with 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 presented with a diagnosis of PTSD according to the DSM-5. Baseline evaluation will comprise clinical and psychometric assessments, magnetic resonance imaging, neuropsychological testing, polysomnography, immune and endocrinal 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 one of the two 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 will be completed by the end of the first semester of 2020.
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. Since PTSD is often challenging to successful treatment, our research may provide important evidence on the efficacy of a non-exposure psychotherapy technique to mitigate symptoms. We aim to obtain evidence on how biological measures are associated with PTSD and treatment response. Clinical Trial: Brazilian Registry of Clinical Trials. RBR-3z474z. Registered 24th of March 2015. http://www.ensaiosclinicos.gov.br/rg/RBR-3z474z/
Citation
Please cite as:
Coimbra BM, Yeh M, D'Elia AT, Maciel MR, Carvalho CM, Milani AC, Mozzambani A, Juruena M, Belangero SI, Jackowski AP, Poyares D, Mello AF, Mello MF
Posttraumatic Stress Disorder and Neuroprogression in Women Following Sexual Assault: Protocol for a Randomized Clinical Trial Evaluating Allostatic Load and Aging Process Acceleration