Posttraumatic Stress Disorder (PTSD)NCT01576510
fMRI Predictors of Treatment Response in Posttraumatic Stress Disorder (PTSD)
A study testing Prolonged Exposure (PE) in people with Posttraumatic Stress Disorder (PTSD), run by Research Foundation for Mental Hygiene, Inc. at 1 site in United States.
Trial summary
To employ a fear learning-extinction paradigm with functional magnetic resonance imaging (fMRI) and skin conductance response (SCR) assessments among patients with posttraumatic stress disorder (PTSD) and trauma exposed healthy controls, aiming to a) clarify neural circuits underlying PTSD and b) to probe brain based… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Posttraumatic Stress Disorder (PTSD)
- What is being tested?
- Prolonged Exposure (PE)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to Jun 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males or females between the ages of 18 and 60
- Current DSM-IV PTSD
- CAPS score equal or greater than 50.
- Able to give consent, fluent in English or Spanish.
Who cannot join
- History of Axis I psychiatric diagnosis (other than as specified), e.g., psychotic disorder, bipolar disorder, obsessive compulsive disorder (OCD), tic disorder, or eating disorder. Note that comorbid current major depressive disorder will be allowed in up to one half of the PTSD group. This will enable inclusion of this common comorbidity, but also enable an assessment of whether or not the presence of this comorbid diagnosis is driving any observed significant between-group differences.
- Depression which is antecedent to PTSD; score of > 25 on the Hamilton Rating Scale for Depression (HAM-D-17-item); significant depression and /or depression related impairment that is judged to warrant pharmacotherapy or combined medication and psychotherapy.
- Individuals at risk for suicide based on history and current mental state.
- History of substance/alcohol dependence within the past six months, and abuse within past two months
- Patients who are receiving effective medication for their PTSD and/or depression
- Antipsychotic, antidepressant, or mood stabilizer medications in the last 4 weeks prior to the study (6 weeks for fluoxetine). Standing daily dosing of benzodiazepine class of medication in the 2 weeks prior to the study (as needed use of benzodiazepines is not an exclusion, but must be clinically judged to tolerate no benzodiazepines for the 72-hour period before each of the fMRI days). Triptan anti-migraine medications. Other medications that may interfere with fear circuitry and fear memory such as blood-brain-barrier-penetrating β-blockers.
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- Pregnancy, or plans to become pregnant during the period of the study.
- Paramagnetic metallic implants or devices contraindicating magnetic resonance imaging or any other non-removable paramagnetic metal in the body.
- Formal CBT psychotherapy initiated within 3 months of beginning this study.
- Medical illness that could interfere with assessment of diagnosis, treatment response or biological measures (SCR, fMRI), including organic brain impairment from stroke, CNS tumor, or demyelinating disease; and renal, thyroid, hematologic or hepatic impairment
- Current unstable or untreated medical illness, and resting SBP≥140 and DBP≥90 and HR<60 and HR>100
- Any condition that would exclude clinical MR exam (e.g. pacemaker, paramagnetic metallic prosthesis, surgical clips, shrapnel, necessity for constant medicinal patch, some tattoos)
- Significant claustrophobia that would preclude ability to remain calm within the MRI scanner
Trial locations and contacts
1 site in 1 country.
United States1 site
New York State Psychiatric Institute
New York, New York, 10032
About this study
Official title: Brain Circuitry and Psychosocial Predictors of PTSD
To employ a fear learning-extinction paradigm with functional magnetic resonance imaging (fMRI) and skin conductance response (SCR) assessments among patients with posttraumatic stress disorder (PTSD) and trauma exposed healthy controls, aiming to a) clarify neural circuits underlying PTSD and b) to probe brain based predictors of symptomatic improvement in response to Prolonged Exposure (PE) treatment, and first line treatment for PTSD.
Read the detailed description
Posttraumatic stress disorder (PTSD) is highly prevalent and debilitating disorder. It is defined by a fearful response to traumatic events, and its clinical picture includes reexperiencing, arousal, and avoidance to reminders of the exposure. Despite efforts to characterize the pathophysiology of PTSD, no biomarkers have been established that aid in diagnosis, treatment development, or prediction of treatment response.
Several lines of evidence suggest that PTSD symptoms are mediated by dysfunctional processes involving the brain's fear-circuitry network in general, and extinction learning and recall deficits in particular. Based on our preliminary work in applying fear extinction task to healthy humans and patients with PTSD the goal of this renewal RO1 application is to employ an established extinction paradigm with functional magnetic resonance imaging (fMRI) and Skin Conductance Response (SCR) assessments in a large and well characterized sample with PTSD and trauma exposed healthy control (TE-HC) subjects. We plan to clarify circuits underlying PTSD psychopathology and to probe, for the first time, neural circuitry of symptomatic improvement in response to Prolonged Exposure (PE) treatment. This goal is congruent with NIMH strategic plan strategy 1.3 ("identify and integrate biological markers and behavioral indicators associated with mental disorders").
One hundred subjects including 60 individuals with a principal diagnosis of PTSD and 40 trauma exposed healthy controls will be assessed by fMRI and SCR to determine the neural circuitry activation to the fear extinction task. fMRI data will be acquired simultaneously with fear extinction and recall measurement quantified by SCR. All 60 PTSD subjects and 20 randomly assigned TE-HCs subjects will repeat these procedures 10 weeks later, after PTSD subjects have completed 10 weeks of intensive PE treatment. Three months after treatment completion clinical ratings of PTSD severity will be conducted to permit analysis of neural predictors of long term treatment durability.
The aims above will be accomplished through four years of study, conducted by a multi-disciplinary research team, comprised of research scientists from Columbia, Harvard and New York Universities, who have conducted studies in PTSD and structural and functional brain imaging. If successful, the study will produce highly needed information on the neural circuitry which underlies deficient extinction and recall in PTSD, and will provide highly important information about the neural effects of Prolonged Exposure treatment, a first line treatment for PTSD. Together these lines of expected findings will not only advance identification of biomarkers associated with PTSD, but also facilitate identification of biomarkers for clinical reponse to an empirically supported treatment.
- Conditions
- Posttraumatic Stress Disorder (PTSD)
- Being tested
- Prolonged Exposure (PE)
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prolonged Exposure (PE)Behavioural
Prolonged Exposure (PE) therapy consists of ten 90-minute sessions. Elements of PE include imaginal and in vivo exposure to trauma reminders; breathing retraining; cognitive restructuring; and PTSD psychoeducation. The therapist helps the patient cognitively restructure his/her experience of the traumatic event. Each week the narrative is elaborated, becoming more detailed and exhaustive, until the patient habituates to it, extinguishing the anxiety it formerly aroused.
| Study group | Role | What they receive |
|---|---|---|
| Prolonged Exposure (PE) treatment. | Experimental | Not described Receives: Behavioral: Prolonged Exposure (PE) |
| Trauma exposed healthy controls | No intervention | Clinical assessments at baseline, 7 and 10 weeks. fMRI assessments at baseline and 10 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change over time in Clinician Administered PTSD Scale (CAPS)
Structured Interview
Measured: Baseline, week 7, week 10, and 3 month follow up
Secondary outcomes (1)
Change over time in brain activation patterns as measured by fMRI
Measured: Baseline and 10 weeks (post treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2012 (estimated)
- Study startAug 2010
- Primary completionMay 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posttraumatic Stress Disorder (PTSD)Studies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Research Foundation for Mental Hygiene, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Harvard University, University of Colorado, Boulder
- Responsible party
- Principal investigator, Yuval Y Neria, Research Foundation for Mental Hygiene, Inc.
- Investigators
- Yuval Neria, PhD, Principal investigator, New York State Psychiatric Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01576510
- Sponsor's protocol ID
- 2R01MH072833-04A2
- Status last verified
- Jun 2014
- First submitted
- 10 Apr 2012
- Last updated
- 24 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Circuitry and Psychosocial Predictors of PTSD
- ClinicalTrials.gov ID
- NCT01576510
- Acronym / sponsor ID
- 2R01MH072833-04A2
- Conditions
- Posttraumatic Stress Disorder (PTSD)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Research Foundation for Mental Hygiene, Inc.University, hospital or other
- Collaborators
- Harvard University, University of Colorado, Boulder
- Study start
- Aug 2010
- Primary completion
- May 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 12 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To employ a fear learning-extinction paradigm with functional magnetic resonance imaging (fMRI) and skin conductance response (SCR) assessments among patients with posttraumatic stress disorder (PTSD) and trauma exposed healthy controls, aiming to a) clarify neural circuits underlying PTSD and b) to probe brain based predictors of symptomatic improvement in response to Prolonged Exposure (PE) treatment, and first line treatment for PTSD.
Detailed description
Posttraumatic stress disorder (PTSD) is highly prevalent and debilitating disorder. It is defined by a fearful response to traumatic events, and its clinical picture includes reexperiencing, arousal, and avoidance to reminders of the exposure. Despite efforts to characterize the pathophysiology of PTSD, no biomarkers have been established that aid in diagnosis, treatment development, or prediction of treatment response.
Several lines of evidence suggest that PTSD symptoms are mediated by dysfunctional processes involving the brain's fear-circuitry network in general, and extinction learning and recall deficits in particular. Based on our preliminary work in applying fear extinction task to healthy humans and patients with PTSD the goal of this renewal RO1 application is to employ an established extinction paradigm with functional magnetic resonance imaging (fMRI) and Skin Conductance Response (SCR) assessments in a large and well characterized sample with PTSD and trauma exposed healthy control (TE-HC) subjects. We plan to clarify circuits underlying PTSD psychopathology and to probe, for the first time, neural circuitry of symptomatic improvement in response to Prolonged Exposure (PE) treatment. This goal is congruent with NIMH strategic plan strategy 1.3 ("identify and integrate biological markers and behavioral indicators associated with mental disorders").
One hundred subjects including 60 individuals with a principal diagnosis of PTSD and 40 trauma exposed healthy controls will be assessed by fMRI and SCR to determine the neural circuitry activation to the fear extinction task. fMRI data will be acquired simultaneously with fear extinction and recall measurement quantified by SCR. All 60 PTSD subjects and 20 randomly assigned TE-HCs subjects will repeat these procedures 10 weeks later, after PTSD subjects have completed 10 weeks of intensive PE treatment. Three months after treatment completion clinical ratings of PTSD severity will be conducted to permit analysis of neural predictors of long term treatment durability.
The aims above will be accomplished through four years of study, conducted by a multi-disciplinary research team, comprised of research scientists from Columbia, Harvard and New York Universities, who have conducted studies in PTSD and structural and functional brain imaging. If successful, the study will produce highly needed information on the neural circuitry which underlies deficient extinction and recall in PTSD, and will provide highly important information about the neural effects of Prolonged Exposure treatment, a first line treatment for PTSD. Together these lines of expected findings will not only advance identification of biomarkers associated with PTSD, but also facilitate identification of biomarkers for clinical reponse to an empirically supported treatment.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prolonged Exposure (PE) treatment. | Experimental | Behavioral: Prolonged Exposure (PE) |
| Trauma exposed healthy controls | No intervention | –Clinical assessments at baseline, 7 and 10 weeks. fMRI assessments at baseline and 10 weeks. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Males or females between the ages of 18 and 60
- Current DSM-IV PTSD
- CAPS score equal or greater than 50.
- Able to give consent, fluent in English or Spanish.
Key exclusion criteria (13 listed)
- History of Axis I psychiatric diagnosis (other than as specified), e.g., psychotic disorder, bipolar disorder, obsessive compulsive disorder (OCD), tic disorder, or eating disorder. Note that comorbid current major depressive disorder will be allowed in up to one half of the PTSD group. This will enable inclusion of this common comorbidity, but also enable an assessment of whether or not the presence of this comorbid diagnosis is driving any observed significant between-group differences.
- Depression which is antecedent to PTSD; score of > 25 on the Hamilton Rating Scale for Depression (HAM-D-17-item); significant depression and /or depression related impairment that is judged to warrant pharmacotherapy or combined medication and psychotherapy.
- Individuals at risk for suicide based on history and current mental state.
- History of substance/alcohol dependence within the past six months, and abuse within past two months
- Patients who are receiving effective medication for their PTSD and/or depression
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 |
|---|---|---|
| Prolonged Exposure (PE)Prolonged Exposure (PE) therapy consists of ten 90-minute sessions. Elements of PE include imaginal and in vivo exposure to trauma reminders; breathing retraining; cognitive restructuring; and PTSD psychoeducation. The therapist helps the patient cognitively restructure his/her experience of the traumatic event. Each week the narrative is elaborated, becoming more detailed and exhaustive, until the patient habituates to it, extinguishing the anxiety it formerly aroused. | Behavioural | Prolonged Exposure (PE) treatment. |
Primary outcome
Change over time in Clinician Administered PTSD Scale (CAPS)
Time frame: Baseline, week 7, week 10, and 3 month follow up
Structured Interview
1 secondary outcome
Change over time in brain activation patterns as measured by fMRI
Time frame: Baseline and 10 weeks (post treatment)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2014.
- Trauma and PTSD Program at New York State psychiatric InstituteLink provided by the sponsor.
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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.
Yuval Neria, PhD principal investigator
New York State Psychiatric Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prolonged Exposure (PE) in people with Posttraumatic Stress Disorder (PTSD), run by Research Foundation for Mental Hygiene, Inc. 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 4 inclusion and 13 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: finished, as of the sponsor's last update on 24 Jun 2014. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change over time in Clinician Administered PTSD Scale (CAPS) (time frame: Baseline, week 7, week 10, and 3 month follow up). 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 24 Jun 2014.