Post-Traumatic Stress Disorder Clinical Trial
Official title:
Effectiveness of Prolonged Exposure Therapy on Reducing Neuroendocrine-Related Symptoms of Post-Traumatic Stress Disorder in Women
This study will determine the effectiveness of immediate treatment with prolonged exposure therapy (PE) versus delaying treatment with PE in altering neuroendocrine-related symptoms of post-traumatic stress disorder in women.
Post-Traumatic Stress Disorder (PTSD) is a psychiatric disorder that can occur following
exposure to a traumatic incident in which grave physical harm occurred or was threatened.
PTSD is marked by clear biological changes as well as psychological symptoms. Many people
with PTSD repeatedly relive the trauma in the form of flashback episodes, memories,
nightmares, or frightening thoughts. Chronic PTSD can also affect the neuroendocrine system
by altering functionality of some chemicals in the brain, including cortisol and
catecholamines (e.g., norepinephrine). This study will determine the effectiveness of
immediate treatment with prolonged exposure therapy (PE) versus delaying treatment with PE
in altering neuroendocrine-related symptoms of post-traumatic stress disorder in women.
This single-blind study will randomly assign two thirds of participants to PE therapy
immediately following a traumatic event and one third to a waitlist condition (WL), in which
they will receive no treatment until a later date. Participants assigned to receive PE will
do so once weekly for 10 weeks. Participants assigned to the WL condition will receive no
treatment for 10 weeks, and then will begin PE therapy once weekly for an additional 10
weeks. Study visits will occur at baseline, Week 10, and 6 months post-treatment for those
in both conditions, with additional visits 10 weeks and 6 months post-PE therapy for those
in the WL condition. Psychological measurements to be assessed at these visits will include
PTSD symptoms, anxiety, depression, and PTSD-related cognitions. Physical assessments will
include urine and saliva tests, as well as a dexamethasone-suppression test. Participants in
the PE condition will also provide saliva samples at points throughout the study to monitor
changes in cortisol and catecholamines.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment
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