Post-Traumatic Stress DisorderPhase 4NCT00391430
Cognitive Behavioral Therapy Versus Sertraline in the Treatment of Post-Traumatic Stress Disorder
A Phase 4 study testing Sertraline and Cognitive behavioral therapy (CBT) in people with Post-Traumatic Stress Disorder, run by NYU Langone Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Post-Traumatic Stress Disorder
- What is being tested?
- Sertraline and Cognitive behavioral therapy (CBT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- May 2005to Jul 2009
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 13Show fewer
- 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
Who cannot join
- 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
Show all 28Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
NYU Institute for Trauma & Resilience
New York, New York, 10016
About this study
Official title: Cognitive Behavioral Therapy vs. Sertraline in the Treatment of Post Traumatic Stress Disorder
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.
Read the 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
- Conditions
- Post-Traumatic Stress Disorder
- Being tested
- Sertraline, Cognitive behavioral therapy (CBT)
- Keywords
- PTSD, Trauma, Sexual Abuse, Sexual Assault
- Medical subject headings
- Stress Disorders, Post-Traumatic, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SertralineDrug
Dosage: up to 100 mg/day; Frequency: once per day; Duration: 12 weeks
Cognitive behavioral therapy (CBT)Behavioural
CBT consists of sixteen 1-hour sessions during a period of 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Participants assigned to the control condition will receive no treatment |
| Sertraline | Active comparator | Participants will receive treatment with sertraline Receives: Drug: Sertraline |
| CBT | Active comparator | Participants will receive cognitive behavioral therapy Receives: Behavioral: Cognitive behavioral therapy (CBT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Salivary Cortisol Levels (Measured Before, During, and After the fMRI)
Salivary cortisol levels (measured before, during, and after the fMRI)
Measured: Measured 3 days before and after treatment and 1 day during fMRI
Fear Response (Measured During the fMRI)
Fear response (measured during the fMRI) in response to positive fearful and neutral stimuli
Measured: Measured on 1 day during two MRIs
Secondary outcomes (20)
Trauma History Inventory (THI)
Assesses the full range of traumatic stressor over lifetime
Measured: Measured 30 minutes before and after treatment
Clinician-Administered PTSD Scale for DSM-IV (CAPS)
Assesses severity and frequency of PTSD symptoms and provides information for diagnosis
Measured: Measured 30 minutes before and after treatment
Structured Clinical Interview for DSM-IV I and II (SCID I and II)
Provides assessment of all anxiety and mood disorder diagnoses
Measured: Measured 1 hour before and after treatment
Panic Disorder Severity Scale (PDSS)
measure of frequency and severity of panic attacks
Measured: Measured 15 minutes before and after treatment
Clinical Global Impressions Severity Scale
Assesses functional status of individual
Measured: Measured weekly throughout the study
Clinical Global Impressions Improvement Scale
Assesses improvement in functioning
Measured: Measured weekly throughout the study
Sociodemographic Questionnaire
social and demographic characteristics of the individual
Measured: Measured at baseline
Penn State Worry Questionnaire (PSWQ)
assesses worry and rumination
Measured: Measured 10 minutes, before, during, and after treatment
Post Traumatic Stress Disorder Symptom Scale-Self Report (PSS-SR)
self-report measure of PTSD symptoms
Measured: Measured 10 times throughout study
Brief Symptom Inventory (BSI)
assesses a wide range of symptoms regarding the distress they cause
Measured: Measured 10 times throughout study
General Expectancy for Negative Mood Regulation (NMR)
assesses ability to regulate mood states
Measured: Measured 3 times throughout study
State-Trait Anger Expression (STAXI)
assess experience of anger as both a state and trait like phenomenon
Measured: Measured 10 times throughout study
Toronto Alexithymia Scale (TAS)
assesses difficulty in identifying and naming feelings
Measured: Measured 2 times throughout study
The State-Trait Anxiety Inventory (STAI)
assesses types and severity of anxiety
Measured: Measured 10 times throughout study
Beck Depression Inventory (BDI)
assesses type and severity of depression
Measured: Measured 3 times throughout study
The Inventory of Interpersonal Problems (IIP)
assesses type and severity of interpersonal problems
Measured: Measured 2 times throughout study
The Social Adjustment Scale - Self Report (SAS-SR)
assesses social adjustment
Measured: Measured 2 times throughout study
fMRI Safety Information Checklist
review safety information related to fMRI procedure
Measured: Measured 2 times throughout study
Medical History 12 Months (MH)
assessment of medical problems in past 12 months
Measured: Measured throughout study
Health Services Utilization Form-12 Months (HSUF)
assessment of type and frequency of use of medical services
Measured: Measured throughout study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2006 (estimated)
- Study startMay 2005
- Primary completionJul 2009
- Study completionJul 2009
Why it stopped: Difficulty enrolling subjects
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Post-Traumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Marylene Cloitre, PhD, Principal investigator, NYU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00391430
- Sponsor's protocol ID
- P50MH058911
- Other IDs
- P50MH058911, DATR A3-NSC
- Status last verified
- Jun 2021
- First submitted
- 20 Oct 2006
- Last updated
- 21 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Behavioral Therapy vs. Sertraline in the Treatment of Post Traumatic Stress Disorder
- ClinicalTrials.gov ID
- NCT00391430
- Acronym / sponsor ID
- P50MH058911
- Conditions
- Post-Traumatic Stress Disorder
- Keywords
- PTSD, Trauma, Sexual Abuse, Sexual Assault
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty enrolling subjects
- Enrolment
- 39 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- May 2005
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 24 Oct 2006 (estimated)
- Results
- Posted 21 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Participants assigned to the control condition will receive no treatment |
| Sertraline | Active comparator | Drug: SertralineParticipants will receive treatment with sertraline |
| CBT | Active comparator | Behavioral: Cognitive behavioral therapy (CBT)Participants will receive cognitive behavioral therapy |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (28 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SertralineDosage: up to 100 mg/day; Frequency: once per day; Duration: 12 weeks | Drug | Sertraline |
| Cognitive behavioral therapy (CBT)CBT consists of sixteen 1-hour sessions during a period of 12 weeks. | Behavioural | CBT |
Primary outcome
Salivary Cortisol Levels (Measured Before, During, and After the fMRI)
Time frame: 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)
Time frame: Measured on 1 day during two MRIs
Fear response (measured during the fMRI) in response to positive fearful and neutral stimuli
20 secondary outcomes
Trauma History Inventory (THI)
Time frame: Measured 30 minutes before and after treatment
Clinician-Administered PTSD Scale for DSM-IV (CAPS)
Time frame: Measured 30 minutes before and after treatment
Structured Clinical Interview for DSM-IV I and II (SCID I and II)
Time frame: Measured 1 hour before and after treatment
Panic Disorder Severity Scale (PDSS)
Time frame: Measured 15 minutes before and after treatment
Clinical Global Impressions Severity Scale
Time frame: Measured weekly throughout the study
Clinical Global Impressions Improvement Scale
Time frame: Measured weekly throughout the study
Sociodemographic Questionnaire
Time frame: Measured at baseline
Penn State Worry Questionnaire (PSWQ)
Time frame: Measured 10 minutes, before, during, and after treatment
Post Traumatic Stress Disorder Symptom Scale-Self Report (PSS-SR)
Time frame: Measured 10 times throughout study
Brief Symptom Inventory (BSI)
Time frame: Measured 10 times throughout study
General Expectancy for Negative Mood Regulation (NMR)
Time frame: Measured 3 times throughout study
State-Trait Anger Expression (STAXI)
Time frame: Measured 10 times throughout study
Toronto Alexithymia Scale (TAS)
Time frame: Measured 2 times throughout study
The State-Trait Anxiety Inventory (STAI)
Time frame: Measured 10 times throughout study
Beck Depression Inventory (BDI)
Time frame: Measured 3 times throughout study
The Inventory of Interpersonal Problems (IIP)
Time frame: Measured 2 times throughout study
The Social Adjustment Scale - Self Report (SAS-SR)
Time frame: Measured 2 times throughout study
fMRI Safety Information Checklist
Time frame: Measured 2 times throughout study
Medical History 12 Months (MH)
Time frame: Measured throughout study
Health Services Utilization Form-12 Months (HSUF)
Time frame: Measured throughout study
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marylene Cloitre, PhD principal investigator
NYU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sertraline and Cognitive behavioral therapy (CBT) in people with Post-Traumatic Stress Disorder, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Salivary Cortisol Levels (Measured Before, During, and After the fMRI) (time frame: Measured 3 days before and after treatment and 1 day during fMRI). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2021.