Back to resultsCognitive Behavioral Therapy Versus Sertraline in the Treatment of Post-Traumatic Stress Disorder
Primary Purpose
Post-Traumatic Stress Disorder
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Sertraline
Cognitive behavioral therapy (CBT)
Sponsored by
About this trial
This is an interventional treatment trial for Post-Traumatic Stress Disorder focused on measuring PTSD, Trauma, Sexual Abuse, Sexual Assault
Eligibility 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
Sites / Locations
- NYU Institute for Trauma & Resilience
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Active Comparator
Active Comparator
Arm Label
Control
Sertraline
CBT
Arm Description
Participants assigned to the control condition will receive no treatment
Participants will receive treatment with sertraline
Participants will receive cognitive behavioral therapy
Outcomes
Primary Outcome Measures
Salivary Cortisol Levels (Measured Before, During, and After the fMRI)
Salivary cortisol levels (measured before, during, and after the fMRI)
Fear Response (Measured During the fMRI)
Fear response (measured during the fMRI) in response to positive fearful and neutral stimuli
Secondary Outcome Measures
Trauma History Inventory (THI)
Assesses the full range of traumatic stressor over lifetime
Clinician-Administered PTSD Scale for DSM-IV (CAPS)
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)
Provides assessment of all anxiety and mood disorder diagnoses
Panic Disorder Severity Scale (PDSS)
measure of frequency and severity of panic attacks
Clinical Global Impressions Severity Scale
Assesses functional status of individual
Clinical Global Impressions Improvement Scale
Assesses improvement in functioning
Sociodemographic Questionnaire
social and demographic characteristics of the individual
Penn State Worry Questionnaire (PSWQ)
assesses worry and rumination
Post Traumatic Stress Disorder Symptom Scale-Self Report (PSS-SR)
self-report measure of PTSD symptoms
Brief Symptom Inventory (BSI)
assesses a wide range of symptoms regarding the distress they cause
General Expectancy for Negative Mood Regulation (NMR)
assesses ability to regulate mood states
State-Trait Anger Expression (STAXI)
assess experience of anger as both a state and trait like phenomenon
Toronto Alexithymia Scale (TAS)
assesses difficulty in identifying and naming feelings
The State-Trait Anxiety Inventory (STAI)
assesses types and severity of anxiety
Beck Depression Inventory (BDI)
assesses type and severity of depression
The Inventory of Interpersonal Problems (IIP)
assesses type and severity of interpersonal problems
The Social Adjustment Scale - Self Report (SAS-SR)
assesses social adjustment
fMRI Safety Information Checklist
review safety information related to fMRI procedure
Medical History 12 Months (MH)
assessment of medical problems in past 12 months
Health Services Utilization Form-12 Months (HSUF)
assessment of type and frequency of use of medical services
Full Information
NCT ID
NCT00391430
First Posted
October 20, 2006
Last Updated
June 30, 2021
Sponsor
NYU Langone Health
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT00391430
Brief Title
Cognitive Behavioral Therapy Versus Sertraline in the Treatment of Post-Traumatic Stress Disorder
Official Title
Cognitive Behavioral Therapy vs. Sertraline in the Treatment of Post Traumatic Stress Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Terminated
Why Stopped
Difficulty enrolling subjects
Study Start Date
May 2005 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
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
Data Monitoring Committee
No
5. 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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Traumatic Stress Disorder
Keywords
PTSD, Trauma, Sexual Abuse, Sexual Assault
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
39 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
Participants assigned to the control condition will receive no treatment
Arm Title
Sertraline
Arm Type
Active Comparator
Arm Description
Participants will receive treatment with sertraline
Arm Title
CBT
Arm Type
Active Comparator
Arm Description
Participants will receive cognitive behavioral therapy
Intervention Type
Drug
Intervention Name(s)
Sertraline
Intervention Description
Dosage: up to 100 mg/day; Frequency: once per day; Duration: 12 weeks
Intervention Type
Behavioral
Intervention Name(s)
Cognitive behavioral therapy (CBT)
Intervention Description
CBT consists of sixteen 1-hour sessions during a period of 12 weeks.
Primary Outcome Measure Information:
Title
Salivary Cortisol Levels (Measured Before, During, and After the fMRI)
Description
Salivary cortisol levels (measured before, during, and after the fMRI)
Time Frame
Measured 3 days before and after treatment and 1 day during fMRI
Title
Fear Response (Measured During the fMRI)
Description
Fear response (measured during the fMRI) in response to positive fearful and neutral stimuli
Time Frame
Measured on 1 day during two MRIs
Secondary Outcome Measure Information:
Title
Trauma History Inventory (THI)
Description
Assesses the full range of traumatic stressor over lifetime
Time Frame
Measured 30 minutes before and after treatment
Title
Clinician-Administered PTSD Scale for DSM-IV (CAPS)
Description
Assesses severity and frequency of PTSD symptoms and provides information for diagnosis
Time Frame
Measured 30 minutes before and after treatment
Title
Structured Clinical Interview for DSM-IV I and II (SCID I and II)
Description
Provides assessment of all anxiety and mood disorder diagnoses
Time Frame
Measured 1 hour before and after treatment
Title
Panic Disorder Severity Scale (PDSS)
Description
measure of frequency and severity of panic attacks
Time Frame
Measured 15 minutes before and after treatment
Title
Clinical Global Impressions Severity Scale
Description
Assesses functional status of individual
Time Frame
Measured weekly throughout the study
Title
Clinical Global Impressions Improvement Scale
Description
Assesses improvement in functioning
Time Frame
Measured weekly throughout the study
Title
Sociodemographic Questionnaire
Description
social and demographic characteristics of the individual
Time Frame
Measured at baseline
Title
Penn State Worry Questionnaire (PSWQ)
Description
assesses worry and rumination
Time Frame
Measured 10 minutes, before, during, and after treatment
Title
Post Traumatic Stress Disorder Symptom Scale-Self Report (PSS-SR)
Description
self-report measure of PTSD symptoms
Time Frame
Measured 10 times throughout study
Title
Brief Symptom Inventory (BSI)
Description
assesses a wide range of symptoms regarding the distress they cause
Time Frame
Measured 10 times throughout study
Title
General Expectancy for Negative Mood Regulation (NMR)
Description
assesses ability to regulate mood states
Time Frame
Measured 3 times throughout study
Title
State-Trait Anger Expression (STAXI)
Description
assess experience of anger as both a state and trait like phenomenon
Time Frame
Measured 10 times throughout study
Title
Toronto Alexithymia Scale (TAS)
Description
assesses difficulty in identifying and naming feelings
Time Frame
Measured 2 times throughout study
Title
The State-Trait Anxiety Inventory (STAI)
Description
assesses types and severity of anxiety
Time Frame
Measured 10 times throughout study
Title
Beck Depression Inventory (BDI)
Description
assesses type and severity of depression
Time Frame
Measured 3 times throughout study
Title
The Inventory of Interpersonal Problems (IIP)
Description
assesses type and severity of interpersonal problems
Time Frame
Measured 2 times throughout study
Title
The Social Adjustment Scale - Self Report (SAS-SR)
Description
assesses social adjustment
Time Frame
Measured 2 times throughout study
Title
fMRI Safety Information Checklist
Description
review safety information related to fMRI procedure
Time Frame
Measured 2 times throughout study
Title
Medical History 12 Months (MH)
Description
assessment of medical problems in past 12 months
Time Frame
Measured throughout study
Title
Health Services Utilization Form-12 Months (HSUF)
Description
assessment of type and frequency of use of medical services
Time Frame
Measured throughout study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marylene Cloitre, PhD
Organizational Affiliation
NYU
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Institute for Trauma & Resilience
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Cognitive Behavioral Therapy Versus Sertraline in the Treatment of Post-Traumatic Stress Disorder
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