Conditions: Post-Traumatic Stress Disorder
Keywords: PTSD Trauma Sexual Abuse Sexual Assault
Allocation: NON_RANDOMIZED | Intervention model: FACTORIAL
Enrollment: 39
Healthy volunteers: yes

Brief summary:
This study will evaluate which parts of the brain are affected by treatment with behavioral therapy versus medication therapy in people with post-traumatic stress disorder.

Detailed description:
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

Arms:
arm 1: Participants assigned to the control condition will receive no treatment arm 2: Participants will receive treatment with sertraline arm 3: Participants will receive cognitive behavioral therapy

Interventions: intervention 1: Sertraline intervention 2: Cognitive behavioral therapy (CBT)
Intervention descriptions: intervention 1: Dosage: up to 100 mg/day; Frequency: once per day; Duration: 12 weeks intervention 2: CBT consists of sixteen 1-hour sessions during a period of 12 weeks.

Protocol document: