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.
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
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
39
Dosage: up to 100 mg/day; Frequency: once per day; Duration: 12 weeks
CBT consists of sixteen 1-hour sessions during a period of 12 weeks.
NYU Institute for Trauma & Resilience
New York, New York, United States
Salivary Cortisol Levels (Measured Before, During, and After the fMRI)
Salivary cortisol levels (measured before, during, and after the fMRI)
Time frame: Measured 3 days before and after treatment and 1 day during fMRI
Fear Response (Measured During the fMRI)
Fear response (measured during the fMRI) in response to positive fearful and neutral stimuli
Time frame: Measured on 1 day during two MRIs
Trauma History Inventory (THI)
Assesses the full range of traumatic stressor over lifetime
Time frame: Measured 30 minutes before and after treatment
Clinician-Administered PTSD Scale for DSM-IV (CAPS)
Assesses severity and frequency of PTSD symptoms and provides information for diagnosis
Time frame: Measured 30 minutes before and after treatment
Structured Clinical Interview for DSM-IV I and II (SCID I and II)
Provides assessment of all anxiety and mood disorder diagnoses
Time frame: Measured 1 hour before and after treatment
Panic Disorder Severity Scale (PDSS)
measure of frequency and severity of panic attacks
Time frame: Measured 15 minutes before and after treatment
Clinical Global Impressions Severity Scale
Assesses functional status of individual
Time frame: Measured weekly throughout the study
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Clinical Global Impressions Improvement Scale
Assesses improvement in functioning
Time frame: Measured weekly throughout the study
Sociodemographic Questionnaire
social and demographic characteristics of the individual
Time frame: Measured at baseline
Penn State Worry Questionnaire (PSWQ)
assesses worry and rumination
Time frame: Measured 10 minutes, before, during, and after treatment
Post Traumatic Stress Disorder Symptom Scale-Self Report (PSS-SR)
self-report measure of PTSD symptoms
Time frame: Measured 10 times throughout study
Brief Symptom Inventory (BSI)
assesses a wide range of symptoms regarding the distress they cause
Time frame: Measured 10 times throughout study
General Expectancy for Negative Mood Regulation (NMR)
assesses ability to regulate mood states
Time frame: Measured 3 times throughout study
State-Trait Anger Expression (STAXI)
assess experience of anger as both a state and trait like phenomenon
Time frame: Measured 10 times throughout study
Toronto Alexithymia Scale (TAS)
assesses difficulty in identifying and naming feelings
Time frame: Measured 2 times throughout study
The State-Trait Anxiety Inventory (STAI)
assesses types and severity of anxiety
Time frame: Measured 10 times throughout study
Beck Depression Inventory (BDI)
assesses type and severity of depression
Time frame: Measured 3 times throughout study
The Inventory of Interpersonal Problems (IIP)
assesses type and severity of interpersonal problems
Time frame: Measured 2 times throughout study
The Social Adjustment Scale - Self Report (SAS-SR)
assesses social adjustment
Time frame: Measured 2 times throughout study
fMRI Safety Information Checklist
review safety information related to fMRI procedure
Time frame: Measured 2 times throughout study
Medical History 12 Months (MH)
assessment of medical problems in past 12 months
Time frame: Measured throughout study
Health Services Utilization Form-12 Months (HSUF)
assessment of type and frequency of use of medical services
Time frame: Measured throughout study