Relationship Between the Biological and Psychological Correlates of PTSD



Status:Completed
Conditions:Psychiatric, Psychiatric
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:September 2001
End Date:July 2007

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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.

Inclusion Criteria:

- Chronic post-traumatic stress disorder

- Minimum of 3 months passed since traumatic event happened

- Agree to use an effective form of contraception throughout the study

Exclusion Criteria:

- History of schizophrenia, bipolar disorder, or cognitive dysfunction due to a general
medical condition

- History of alcohol or other drug abuse or dependence within 3 months of study
enrollment

- Mental retardation or other pervasive developmental disorder

- Unwillingness or inability to discontinue current psychotherapy treatment (stable
psychiatric medication therapy taken during the study is not criteria for exclusion)

- Significant risk of violence or history of serious violent behavior within one year
of study enrollment

- Medically unstable condition

- Continuing intimate relationship with the perpetrator when the trauma involves
assault

- At risk for suicide risk

- Currently pregnant
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