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

Phase 4

Terminated

Conditions: Post-Traumatic Stress Disorder

Interventions: Behavioral: Cognitive behavioral therapy (CBT)
Drug: Sertraline

Registration Number: NCT00391430

Lead Sponsor: NYU Langone Health

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

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 39

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
CBT	Cognitive behavioral therapy (CBT)	Participants will receive cognitive behavioral therapy
Sertraline	Sertraline	Participants will receive treatment with sertraline

Primary Outcome Measures

Name	Time	Method
Salivary Cortisol Levels (Measured Before, During, and After the fMRI)	Measured 3 days before and after treatment and 1 day during fMRI	Salivary cortisol levels (measured before, during, and after the fMRI)
Fear Response (Measured During the fMRI)	Measured on 1 day during two MRIs	Fear response (measured during the fMRI) in response to positive fearful and neutral stimuli

Secondary Outcome Measures

Name	Time	Method
Trauma History Inventory (THI)	Measured 30 minutes before and after treatment	Assesses the full range of traumatic stressor over lifetime
Clinician-Administered PTSD Scale for DSM-IV (CAPS)	Measured 30 minutes before and after treatment	Assesses severity and frequency of PTSD symptoms and provides information for diagnosis
Structured Clinical Interview for DSM-IV I and II (SCID I and II)	Measured 1 hour before and after treatment	Provides assessment of all anxiety and mood disorder diagnoses
Beck Depression Inventory (BDI)	Measured 3 times throughout study	assesses type and severity of depression
Medical History 12 Months (MH)	Measured throughout study	assessment of medical problems in past 12 months
Clinical Global Impressions Improvement Scale	Measured weekly throughout the study	Assesses improvement in functioning
The Social Adjustment Scale - Self Report (SAS-SR)	Measured 2 times throughout study	assesses social adjustment
Penn State Worry Questionnaire (PSWQ)	Measured 10 minutes, before, during, and after treatment	assesses worry and rumination
General Expectancy for Negative Mood Regulation (NMR)	Measured 3 times throughout study	assesses ability to regulate mood states
State-Trait Anger Expression (STAXI)	Measured 10 times throughout study	assess experience of anger as both a state and trait like phenomenon
The Inventory of Interpersonal Problems (IIP)	Measured 2 times throughout study	assesses type and severity of interpersonal problems
Health Services Utilization Form-12 Months (HSUF)	Measured throughout study	assessment of type and frequency of use of medical services
Brief Symptom Inventory (BSI)	Measured 10 times throughout study	assesses a wide range of symptoms regarding the distress they cause
Toronto Alexithymia Scale (TAS)	Measured 2 times throughout study	assesses difficulty in identifying and naming feelings
Panic Disorder Severity Scale (PDSS)	Measured 15 minutes before and after treatment	measure of frequency and severity of panic attacks
Clinical Global Impressions Severity Scale	Measured weekly throughout the study	Assesses functional status of individual
Sociodemographic Questionnaire	Measured at baseline	social and demographic characteristics of the individual
Post Traumatic Stress Disorder Symptom Scale-Self Report (PSS-SR)	Measured 10 times throughout study	self-report measure of PTSD symptoms
The State-Trait Anxiety Inventory (STAI)	Measured 10 times throughout study	assesses types and severity of anxiety
fMRI Safety Information Checklist	Measured 2 times throughout study	review safety information related to fMRI procedure