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

Sponsored by:	National Institute of Mental Health (NIMH)
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00391430

Purpose

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	Intervention	Phase
Post-Traumatic Stress Disorder	Drug: Sertraline Behavioral: Cognitive behavioral therapy (CBT)	Phase IV

MedlinePlus related topics: Anxiety Injuries Post-Traumatic Stress Disorder Wounds

Drug Information available for: Sertraline hydrochloride Sertraline

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Factorial Assignment, Efficacy Study
Official Title:	Cognitive Behavioral Therapy vs. Sertraline in the Treatment of Post Traumatic Stress Disorder

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:

Salivary cortisol levels (measured before, during, and after the fMRI) [ Time Frame: Measured 3 days before and after treatment and 1 day during fMRI ] [ Designated as safety issue: No ]
Fear response (measured during the fMRI) [ Time Frame: Measured on 1 day during two MRIs ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Trauma History Inventory (THI) [ Time Frame: Measured 30 minutes before and after treatment ] [ Designated as safety issue: No ]
Clinician-Administered PTSD Scale for DSM-IV (CAPS) [ Time Frame: Measured 30 minutes before and after treatment ] [ Designated as safety issue: No ]
Structured Clinical Interview for DSM-IV I and II (SCID I and II) [ Time Frame: Measured 1 hour before and after treatment ] [ Designated as safety issue: No ]
Panic Disorder Severity Scale (PDSS) [ Time Frame: Measured 15 minutes before and after treatment ] [ Designated as safety issue: No ]
Clinical Global Impressions Severity Scale [ Time Frame: Measured weekly throughout the study ] [ Designated as safety issue: No ]
Clinical Global Impressions Improvement Scale [ Time Frame: Measured weekly throughout the study ] [ Designated as safety issue: No ]
Sociodemographic Questionnaire [ Time Frame: Measured at baseline ] [ Designated as safety issue: No ]
Penn State Worry Questionnaire (PSWQ) [ Time Frame: Measured 10 minutes, before, during, and after treatment ] [ Designated as safety issue: No ]
Post Traumatic Stress Disorder Symptom Scale-Self Report (PSS-SR) [ Time Frame: Measured 10 times throughout study ] [ Designated as safety issue: No ]
Brief Symptom Inventory (BSI) [ Time Frame: Measured 10 times throughout study ] [ Designated as safety issue: No ]
General Expectancy for Negative Mood Regulation (NMR) [ Time Frame: Measured 3 times throughout study ] [ Designated as safety issue: No ]
State-Trait Anger Expression (STAXI) [ Time Frame: Measured 10 times throughout study ] [ Designated as safety issue: No ]
Toronto Alexithymia Scale (TAS) [ Time Frame: Measured 2 times throughout study ] [ Designated as safety issue: No ]
The State-Trait Anxiety Inventory (STAI) [ Time Frame: Measured 10 times throughout study ] [ Designated as safety issue: No ]
Beck Depression Inventory (BDI) [ Time Frame: Measured 3 times throughout study ] [ Designated as safety issue: No ]
The Inventory of Interpersonal Problems (IIP) [ Time Frame: Measured 2 times throughout study ] [ Designated as safety issue: No ]
The Social Adjustment Scale - Self Report (SAS-SR) [ Time Frame: Measured 2 times throughout study ] [ Designated as safety issue: No ]
fMRI Safety Information Checklist [ Time Frame: Measured 2 times throughout study ] [ Designated as safety issue: Yes ]
Medical History 12 Months (MH) [ Time Frame: Measured throughout study ] [ Designated as safety issue: No ]
Health Services Utilization Form-12 Months (HSUF) [ Time Frame: Measured throughout study ] [ Designated as safety issue: No ]

Estimated Enrollment:	90
Study Start Date:	May 2005
Estimated Study Completion Date:	May 2009
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

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

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.

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00391430

Contacts

Contact: Kate Kuhlman, BA	212-263-2483	kate.kuhlman@med.nyu.edu
Contact: Christie Jackson, PhD	212-263-8846	Christie.Jackson@nyumc.org

Locations

United States, New York
NYU Institute for Trauma & Resilience	Recruiting
New York, New York, United States, 10016
Contact: Kate Kuhlman, BA 212-263-2483 kate.kuhlman@med.nyu.edu
Contact: Christie Jackson, PhD 212-263-8846 Christie.Jackson@nyumc.org
Principal Investigator: Marylene Cloitre, PhD

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

Investigators

Principal Investigator:

Marylene Cloitre, PhD

NYU

More Information

Responsible Party:	Institute for Trauma & Resilience, New York University School of Medicine ( Marylene Cloitre, PhD )
Study ID Numbers:	P50 MH58911, DATR A3-NSC
Study First Received:	October 20, 2006
Last Updated:	August 20, 2008
ClinicalTrials.gov Identifier:	NCT00391430
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):

PTSD
Trauma
Sexual Abuse
Sexual Assault

Study placed in the following topic categories:

Anxiety Disorders
Mental Disorders
Wounds and Injuries
Sertraline

Stress Disorders, Post-Traumatic
Stress
Serotonin
Stress Disorders, Traumatic

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Disease
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Uptake Inhibitors

Pharmacologic Actions
Pathologic Processes
Serotonin Agents
Therapeutic Uses
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on January 30, 2009