Cognitive Behavioral Therapy Versus Sertraline in the Treatment of Post-Traumatic Stress Disorder

Post-traumatic stress disorder (PTSD) is an anxiety disorder that can develop after exposure
to a traumatic event. PTSD symptoms may include emotional numbness, loss of interest in
activities that were once enjoyable, irritability, and sleep problems. Medication therapy,
behavioral therapy, and a combination of both therapies are among the available treatment
options for people with PTSD. Cognitive behavioral therapy (CBT), a type of talking therapy
that has been shown to be effective in treating PTSD, teaches patients how to alter their
thinking to, in turn, improve how they feel. A selective serotonin reuptake inhibitor (SSRI)
is a type of medication that has also been effective in treating PTSD. Information about the
comparative physiological effects of each of these treatments on people with PTSD is needed.
This study will evaluate which parts of the brain are affected by CBT treatment versus SSRI
treatment in people with PTSD.

Participants with and without PTSD will be enrolled in this 12-week, open label study.
Following a screening visit to determine eligibility, participants with PTSD will be offered
a choice of either CBT or SSRI treatment. Those participants who choose CBT will attend 16
therapy sessions. The first phase of therapy will focus on the development of emotional and
interpersonal regulation skills. The second phase will use a modified form of prolonged
exposure therapy, which has been effective in reducing symptoms of PTSD. Participants who
elect to receive medication will take sertraline, an SSRI that has been safe and effective
in treating PTSD. These participants will attend 12 treatment sessions. Pre- and
post-treatment fear response will be assessed in all participants using fMRI scans to
measure brain responses and using saliva samples to test cortisol levels. All participants
will also self-administer saliva samples at various points during the 3 days prior to fMRI
scanning. Other outcomes will be assessed throughout the study using questionnaires.

For information on a related study, please follow this link:

http://clinicaltrials.gov/show/NCT00648375

Inclusion Criteria:

For people with PTSD:

- Meets DSM-IV criteria for PTSD

- Medically healthy

- Right handed

- Learned English prior to age 5

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

For healthy controls:

- Medically healthy

- Right handed

- Has experienced a qualifying traumatic event

- Does not meet DSM-IV criteria for present or past PTSD

- Learned English prior to age 5

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

Exclusion Criteria:

For people with PTSD:

- Meets DSM-IV criteria for panic disorder within 6 months prior to study entry

- Current suicide risk

- History of DSM-IV diagnosis of any the following conditions: schizophrenia, bipolar
mood disorder, obsessive compulsive disorder (including trichotillomania), or eating
disorder

- Meets DSM-IV criteria for substance use or dependence within the 6 months prior to
study entry

- Any substance abuse within 2 weeks prior to study entry

- Score of greater than 22 on the 17-item Hamilton Rating Scale for Depression (HAM-D)
with depressive symptoms secondary to PTSD

- Current participation in cognitive behavioral psychotherapy that is specifically
designed to treat PTSD

- Concomitant psychoactive medications

- History of cerebrovascular accident (CVA) or any disorder that causes chronic
neurological problems

- Medical illness with central nervous system (CNS) involvement or currently taking
medication that affects the CNS

- Unstable general medical illness requiring intervention (e.g., HIV infection)

- Pregnant, breastfeeding, or plans to become pregnant

- Presence of internal metallic objects, such as heart pacemaker, shrapnel, bullets,
surgical prostheses, surgical clips, or pins

- History of gastric bypass surgery

For healthy controls:

- Any history of generalized anxiety disorder or panic disorder

- Any history of psychotic disorder, bipolar disorder, or cyclothymia

- Any history of substance abuse or dependence within the 6 months prior to study entry

- Any substance use within 2 weeks prior to study entry

- Any other Axis I disorder within the year prior to study entry, including
obsessive-compulsive disorder and trichotillomania

- Unstable general medical illness requiring intervention (e.g., HIV infection)

- Presence of internal metallic objects, such as heart pacemaker, shrapnel, bullets,
surgical prostheses, surgical clips, or pins

- Concomitant psychoactive medications

- Patients with a history of cerebrovascular accident (CVA) or any disorder that causes
chronic neurological problems

- Medical illness with central nervous system (CNS) involvement or currently taking
medication that affects the CNS

- Cognitive impairment or severe Axis II disorder that will likely affect participation
in the study

- Pregnant, breastfeeding, or plans to become pregnant