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

• ClinicalTrials.gov Identifier: NCT00391430
• Recruitment Status: Completed
• First Posted: October 24, 2006
• Last Update Posted: August 17, 2017
• Sponsor: NYU Langone Health
• Collaborator: National Institute of Mental Health (NIMH)
• Information provided by (Responsible Party): NYU Langone Health

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Post-Traumatic Stress Disorder	Drug: Sertraline; Behavioral: Cognitive behavioral therapy (CBT)	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 90 participants
• Allocation: Non-Randomized
• Intervention Model: Factorial Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Cognitive Behavioral Therapy vs. Sertraline in the Treatment of Post Traumatic Stress Disorder
• Study Start Date: May 2005
• Actual Primary Completion Date: July 2009
• Actual Study Completion Date: July 2009

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Salivary cortisol levels (measured before, during, and after the fMRI) [ Time Frame: Measured 3 days before and after treatment and 1 day during fMRI ]
2. Fear response (measured during the fMRI) [ Time Frame: Measured on 1 day during two MRIs ]

Secondary Outcome Measures :

1. Trauma History Inventory (THI) [ Time Frame: Measured 30 minutes before and after treatment ]
2. Clinician-Administered PTSD Scale for DSM-IV (CAPS) [ Time Frame: Measured 30 minutes before and after treatment ]
3. Structured Clinical Interview for DSM-IV I and II (SCID I and II) [ Time Frame: Measured 1 hour before and after treatment ]
4. Panic Disorder Severity Scale (PDSS) [ Time Frame: Measured 15 minutes before and after treatment ]
5. Clinical Global Impressions Severity Scale [ Time Frame: Measured weekly throughout the study ]
6. Clinical Global Impressions Improvement Scale [ Time Frame: Measured weekly throughout the study ]
7. Sociodemographic Questionnaire [ Time Frame: Measured at baseline ]
8. Penn State Worry Questionnaire (PSWQ) [ Time Frame: Measured 10 minutes, before, during, and after treatment ]
9. Post Traumatic Stress Disorder Symptom Scale-Self Report (PSS-SR) [ Time Frame: Measured 10 times throughout study ]
10. Brief Symptom Inventory (BSI) [ Time Frame: Measured 10 times throughout study ]
11. General Expectancy for Negative Mood Regulation (NMR) [ Time Frame: Measured 3 times throughout study ]
12. State-Trait Anger Expression (STAXI) [ Time Frame: Measured 10 times throughout study ]
13. Toronto Alexithymia Scale (TAS) [ Time Frame: Measured 2 times throughout study ]
14. The State-Trait Anxiety Inventory (STAI) [ Time Frame: Measured 10 times throughout study ]
15. Beck Depression Inventory (BDI) [ Time Frame: Measured 3 times throughout study ]
16. The Inventory of Interpersonal Problems (IIP) [ Time Frame: Measured 2 times throughout study ]
17. The Social Adjustment Scale - Self Report (SAS-SR) [ Time Frame: Measured 2 times throughout study ]
18. fMRI Safety Information Checklist [ Time Frame: Measured 2 times throughout study ]
19. Medical History 12 Months (MH) [ Time Frame: Measured throughout study ]
20. Health Services Utilization Form-12 Months (HSUF) [ Time Frame: Measured throughout study ]

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

United States, New York

NYU Institute for Trauma & Resilience

New York, New York, United States, 10016

Sponsors and Collaborators

NYU Langone Health

National Institute of Mental Health (NIMH)

Investigators

• Principal Investigator: Marylene Cloitre, PhD; NYU

More Information

• Responsible Party: NYU Langone Health
• ClinicalTrials.gov Identifier: NCT00391430
• Other Study ID Numbers: P50MH058911 ( U.S. NIH Grant/Contract ); P50MH058911 ( U.S. NIH Grant/Contract ); DATR A3-NSC
• First Posted: October 24, 2006
• Last Update Posted: August 17, 2017
• Last Verified: August 2017

• 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

Keywords provided by NYU Langone Health:

PTSD; Trauma; Sexual Abuse; Sexual Assault

Additional relevant MeSH terms:

Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Sertraline; Antidepressive Agents; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Agents; Serotonin Agents; Physiological Effects of Drugs