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

Study Overview
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Brief Summary
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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
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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

Official Title
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Cognitive Behavioral Therapy vs. Sertraline in the Treatment of Post Traumatic Stress Disorder

Conditions
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Post-Traumatic Stress Disorder

Intervention / Treatment
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* Drug: Sertraline
* Behavioral: Cognitive behavioral therapy (CBT)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Participants assigned to the control condition will receive no treatment | |
| Active Comparator: Sertraline<br>Participants will receive treatment with sertraline | Drug: Sertraline<br>* Dosage: up to 100 mg/day; Frequency: once per day; Duration: 12 weeks<br>|
| Active Comparator: CBT<br>Participants will receive cognitive behavioral therapy | Behavioral: Cognitive behavioral therapy (CBT)<br>* CBT consists of sixteen 1-hour sessions during a period of 12 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Salivary Cortisol Levels (Measured Before, During, and After the fMRI) | Salivary cortisol levels (measured before, during, and after the fMRI) | 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 | Measured on 1 day during two MRIs | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trauma History Inventory (THI) | Assesses the full range of traumatic stressor over lifetime | 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 | 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 | Measured 1 hour before and after treatment | 
| Panic Disorder Severity Scale (PDSS) | measure of frequency and severity of panic attacks | Measured 15 minutes before and after treatment | 
| Clinical Global Impressions Severity Scale | Assesses functional status of individual | Measured weekly throughout the study | 
| Clinical Global Impressions Improvement Scale | Assesses improvement in functioning | Measured weekly throughout the study | 
| Sociodemographic Questionnaire | social and demographic characteristics of the individual | Measured at baseline | 
| Penn State Worry Questionnaire (PSWQ) | assesses worry and rumination | Measured 10 minutes, before, during, and after treatment | 
| Post Traumatic Stress Disorder Symptom Scale-Self Report (PSS-SR) | self-report measure of PTSD symptoms | Measured 10 times throughout study | 
| Brief Symptom Inventory (BSI) | assesses a wide range of symptoms regarding the distress they cause | Measured 10 times throughout study | 
| General Expectancy for Negative Mood Regulation (NMR) | assesses ability to regulate mood states | Measured 3 times throughout study | 
| State-Trait Anger Expression (STAXI) | assess experience of anger as both a state and trait like phenomenon | Measured 10 times throughout study | 
| Toronto Alexithymia Scale (TAS) | assesses difficulty in identifying and naming feelings | Measured 2 times throughout study | 
| The State-Trait Anxiety Inventory (STAI) | assesses types and severity of anxiety | Measured 10 times throughout study | 
| Beck Depression Inventory (BDI) | assesses type and severity of depression | Measured 3 times throughout study | 
| The Inventory of Interpersonal Problems (IIP) | assesses type and severity of interpersonal problems | Measured 2 times throughout study | 
| The Social Adjustment Scale - Self Report (SAS-SR) | assesses social adjustment | Measured 2 times throughout study | 
| fMRI Safety Information Checklist | review safety information related to fMRI procedure | Measured 2 times throughout study | 
| Medical History 12 Months (MH) | assessment of medical problems in past 12 months | Measured throughout study | 
| Health Services Utilization Form-12 Months (HSUF) | assessment of type and frequency of use of medical services | Measured throughout study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PTSD, Trauma, Sexual Abuse, Sexual Assault