Post-Traumatic Stress Disorder
Conditions
Keywords
PTSD, Trauma, Sexual Abuse, Sexual Assault
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
Interventions
DRUGSertraline
Dosage: up to 100 mg/day; Frequency: once per day; Duration: 12 weeks
BEHAVIORALCognitive behavioral therapy (CBT)
CBT consists of sixteen 1-hour sessions during a period of 12 weeks.
Sponsors
National Institute of Mental Health (NIMH)
NYU Langone Health
Study design
Allocation
NON_RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Salivary Cortisol Levels (Measured Before, During, and After the fMRI) | Measured 3 days before and after treatment and 1 day during fMRI | Salivary cortisol levels (measured before, during, and after the fMRI) |
| Fear Response (Measured During the fMRI) | Measured on 1 day during two MRIs | Fear response (measured during the fMRI) in response to positive fearful and neutral stimuli |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Structured Clinical Interview for DSM-IV I and II (SCID I and II) | Measured 1 hour before and after treatment | Provides assessment of all anxiety and mood disorder diagnoses |
| Panic Disorder Severity Scale (PDSS) | Measured 15 minutes before and after treatment | measure of frequency and severity of panic attacks |
| Clinical Global Impressions Severity Scale | Measured weekly throughout the study | Assesses functional status of individual |
| Clinical Global Impressions Improvement Scale | Measured weekly throughout the study | Assesses improvement in functioning |
| Sociodemographic Questionnaire | Measured at baseline | social and demographic characteristics of the individual |
| Penn State Worry Questionnaire (PSWQ) | Measured 10 minutes, before, during, and after treatment | assesses worry and rumination |
| Post Traumatic Stress Disorder Symptom Scale-Self Report (PSS-SR) | Measured 10 times throughout study | self-report measure of PTSD symptoms |
| Brief Symptom Inventory (BSI) | Measured 10 times throughout study | assesses a wide range of symptoms regarding the distress they cause |
| General Expectancy for Negative Mood Regulation (NMR) | Measured 3 times throughout study | assesses ability to regulate mood states |
| Trauma History Inventory (THI) | Measured 30 minutes before and after treatment | Assesses the full range of traumatic stressor over lifetime |
| Toronto Alexithymia Scale (TAS) | Measured 2 times throughout study | assesses difficulty in identifying and naming feelings |
| The State-Trait Anxiety Inventory (STAI) | Measured 10 times throughout study | assesses types and severity of anxiety |
| Beck Depression Inventory (BDI) | Measured 3 times throughout study | assesses type and severity of depression |
| The Inventory of Interpersonal Problems (IIP) | Measured 2 times throughout study | assesses type and severity of interpersonal problems |
| The Social Adjustment Scale - Self Report (SAS-SR) | Measured 2 times throughout study | assesses social adjustment |
| fMRI Safety Information Checklist | Measured 2 times throughout study | review safety information related to fMRI procedure |
| Medical History 12 Months (MH) | Measured throughout study | assessment of medical problems in past 12 months |
| Health Services Utilization Form-12 Months (HSUF) | Measured throughout study | assessment of type and frequency of use of medical services |
| State-Trait Anger Expression (STAXI) | Measured 10 times throughout study | assess experience of anger as both a state and trait like phenomenon |
| Clinician-Administered PTSD Scale for DSM-IV (CAPS) | Measured 30 minutes before and after treatment | Assesses severity and frequency of PTSD symptoms and provides information for diagnosis |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Participants assigned to the control condition will receive no treatment | 0 |
| Sertraline Participants will receive treatment with sertraline
Sertraline: Dosage: up to 100 mg/day; Frequency: once per day; Duration: 12 weeks | 8 |
| Cognitive Behavioral Therapy Participants will receive cognitive behavioral therapy
Cognitive behavioral therapy (CBT): CBT consists of sixteen 1-hour sessions during a period of 12 weeks. | 31 |
| Total | 39 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Withdrawal by Subject | 3 | 0 | 12 |
Baseline characteristics
| Characteristic | — | Control | Sertraline | Cognitive Behavioral Therapy | Total |
|---|---|---|---|---|---|
| Age, Continuous | — years | — | — | — | — |
| Sex: Female, Male Female | — | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | — | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 3 | 0 / 0 | 0 / 12 |
| other Total, other adverse events | 0 / 3 | 0 / 0 | 0 / 12 |
| serious Total, serious adverse events | 0 / 3 | 0 / 0 | 0 / 12 |
Outcome results
Primary
Fear Response (Measured During the fMRI)
Fear response (measured during the fMRI) in response to positive fearful and neutral stimuli
Time frame: Measured on 1 day during two MRIs
Population: Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.
Primary
Salivary Cortisol Levels (Measured Before, During, and After the fMRI)
Salivary cortisol levels (measured before, during, and after the fMRI)
Time frame: Measured 3 days before and after treatment and 1 day during fMRI
Population: Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.
Secondary
Beck Depression Inventory (BDI)
assesses type and severity of depression
Time frame: Measured 3 times throughout study
Population: Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.
Secondary
Brief Symptom Inventory (BSI)
assesses a wide range of symptoms regarding the distress they cause
Time frame: Measured 10 times throughout study
Population: Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.
Secondary
Clinical Global Impressions Improvement Scale
Assesses improvement in functioning
Time frame: Measured weekly throughout the study
Population: Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.
Secondary
Clinical Global Impressions Severity Scale
Assesses functional status of individual
Time frame: Measured weekly throughout the study
Population: Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.
Secondary
Clinician-Administered PTSD Scale for DSM-IV (CAPS)
Assesses severity and frequency of PTSD symptoms and provides information for diagnosis
Time frame: Measured 30 minutes before and after treatment
Population: Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.
Secondary
fMRI Safety Information Checklist
review safety information related to fMRI procedure
Time frame: Measured 2 times throughout study
Population: Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.
Secondary
General Expectancy for Negative Mood Regulation (NMR)
assesses ability to regulate mood states
Time frame: Measured 3 times throughout study
Population: Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.
Secondary
Health Services Utilization Form-12 Months (HSUF)
assessment of type and frequency of use of medical services
Time frame: Measured throughout study
Population: Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.
Secondary
Medical History 12 Months (MH)
assessment of medical problems in past 12 months
Time frame: Measured throughout study
Population: Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.
Secondary
Panic Disorder Severity Scale (PDSS)
measure of frequency and severity of panic attacks
Time frame: Measured 15 minutes before and after treatment
Population: Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.
Secondary
Penn State Worry Questionnaire (PSWQ)
assesses worry and rumination
Time frame: Measured 10 minutes, before, during, and after treatment
Population: Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.
Secondary
Post Traumatic Stress Disorder Symptom Scale-Self Report (PSS-SR)
self-report measure of PTSD symptoms
Time frame: Measured 10 times throughout study
Population: Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.
Secondary
Sociodemographic Questionnaire
social and demographic characteristics of the individual
Time frame: Measured at baseline
Population: Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.
Secondary
State-Trait Anger Expression (STAXI)
assess experience of anger as both a state and trait like phenomenon
Time frame: Measured 10 times throughout study
Population: Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.
Secondary
Structured Clinical Interview for DSM-IV I and II (SCID I and II)
Provides assessment of all anxiety and mood disorder diagnoses
Time frame: Measured 1 hour before and after treatment
Population: Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.
Secondary
The Inventory of Interpersonal Problems (IIP)
assesses type and severity of interpersonal problems
Time frame: Measured 2 times throughout study
Population: Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.
Secondary
The Social Adjustment Scale - Self Report (SAS-SR)
assesses social adjustment
Time frame: Measured 2 times throughout study
Population: Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.
Secondary
The State-Trait Anxiety Inventory (STAI)
assesses types and severity of anxiety
Time frame: Measured 10 times throughout study
Population: Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.
Secondary
Toronto Alexithymia Scale (TAS)
assesses difficulty in identifying and naming feelings
Time frame: Measured 2 times throughout study
Population: Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.
Secondary
Trauma History Inventory (THI)
Assesses the full range of traumatic stressor over lifetime
Time frame: Measured 30 minutes before and after treatment
Population: Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.