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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT00391430
First received: October 20, 2006
Last updated: April 3, 2013
Last verified: April 2013
  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 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Cognitive Behavioral Therapy vs. Sertraline in the Treatment of Post Traumatic Stress Disorder

Resource links provided by NLM:


Further study details as provided by New York University School of Medicine:

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 ]

Enrollment: 90
Study Start Date: May 2005
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, New York
NYU Institute for Trauma & Resilience
New York, New York, United States, 10016
Sponsors and Collaborators
New York University School of Medicine
Investigators
Principal Investigator: Marylene Cloitre, PhD NYU
  More Information

No publications provided

Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT00391430     History of Changes
Other Study ID Numbers: P50 MH058911, P50MH058911, DATR A3-NSC
Study First Received: October 20, 2006
Last Updated: April 3, 2013
Health Authority: United States: Federal Government

Keywords provided by New York University School of Medicine:
PTSD
Trauma
Sexual Abuse
Sexual Assault

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders
Sertraline
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 26, 2014