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

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

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.

Study Overview

• Status: Terminated
• Conditions: Post-Traumatic Stress Disorder
• Intervention / Treatment: Drug: Sertraline; Behavioral: Cognitive behavioral therapy (CBT)

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

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • NYU Institute for Trauma & Resilience

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Marylene Cloitre, PhD, NYU

Study record dates

Study Major Dates

• Study Start: May 1, 2005
• Primary Completion (Actual): July 1, 2009
• Study Completion (Actual): July 1, 2009

Study Registration Dates

• First Submitted: October 20, 2006
• First Submitted That Met QC Criteria: October 20, 2006
• First Posted (Estimate): October 24, 2006

Study Record Updates

• Last Update Posted (Actual): July 21, 2021
• Last Update Submitted That Met QC Criteria: June 30, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: PTSD; Trauma; Sexual Assault; Sexual Abuse
• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Sertraline
• Other Study ID Numbers: P50MH058911 (U.S. NIH Grant/Contract); DATR A3-NSC (National Institute of Mental Health)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes