Posttraumatic Stress Disorder (PTSD)NCT01507948
Brain Imaging of Psychotherapy for Posttraumatic Stress Disorder (PTSD)
A study testing Prolonged exposure in people with Posttraumatic Stress Disorder (PTSD), run by Stanford University at 2 sites in United States.
Trial summary
The investigators are seeking people who have been exposed to a traumatic event in the past and have symptoms of posttraumatic stress disorder (PTSD) currently. A person with PTSD may feel significant distress when reminded of a traumatic event or feel depressed, anxious or jumpy. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Posttraumatic Stress Disorder (PTSD)
- What is being tested?
- Prolonged exposure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2010to Jan 2016
- 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
- No healthy volunteers
- Adult
Who may be able to join
- age between 18 and 60 years;
- fMRI scanning eligibility, including no evidence of any form of metal embedded in the body (e.g., metal wires, nuts, bolts, screws, plates, sutures), as these produce artifacts when brain imaging;
- not currently involved in an exposure-based psychotherapy, in order to be able to measure and interpret the effects of PE on PTSD;
- must comprehend English well and show non-impaired intellectual abilities to ensure adequate comprehension of the fMRI task instructions and PE treatment;
- no history of neurological or cardiovascular disorders, brain surgery, electroconvulsive or radiation treatment, brain hemorrhage or tumor, stroke, seizures or epilepsy, diabetes, hypo- or hyperthyroidism, head trauma with loss of consciousness greater than thirty minutes;
- no regular use of benzodiazepine, opiate, thyroid, anticonvulsant or antipsychotic medications. Patients on stable doses of antidepressant medications will be allowed. Patients for whom antidepressant dosing is being actively titrated will be required to be on a stable dose for 1 month prior to inclusion in the study.
Who cannot join
- Any contraindication to being scanned in the 3T or 1.5T scanners at the Lucas Center or CNI such as having a pacemaker or implanted device that has not been cleared for scanning at the Lucas Center or CNI.
- Participants will be excluded from the study if there is any lifetime evidence of psychosis, mania, hypomania, or bipolar disorders. Other axis I comorbidities will not be a cause for exclusion.
- In addition, subjects will be excluded if they have a significant CNS neurological condition such as stroke, seizure, tumor, hemorrhage, multiple sclerosis, etc.
- Patients who have current substance dependence will be excluded from the study. A recent diagnosis of substance abuse is allowable, however, as long as subjects have been abstinent for greater than three months.
- Subjects will be excluded if they are currently in an exposure-based psychotherapy for PTSD.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
VA Palo Alto Healthcare System
Palo Alto, California, 94304
Stanford University, Department of Psychiatry
Stanford, California, 94304
About this study
Official title: The Neurobiology of Psychotherapy: Emotional Reactivity and Regulation in PTSD
The investigators are seeking people who have been exposed to a traumatic event in the past and have symptoms of posttraumatic stress disorder (PTSD) currently. A person with PTSD may feel significant distress when reminded of a traumatic event or feel depressed, anxious or jumpy.
As a part of this study, participants will receive brain MRIs and office assessments before and after psychotherapy. The investigators provide the gold-standard psychotherapy for PTSD, "Prolonged Exposure", free of charge; additionally participants are compensated for their time during assessment procedures. This study is exploring the brain circuitry involved in improvement in response to psychotherapy.
- Conditions
- Posttraumatic Stress Disorder (PTSD)
- Being tested
- Prolonged exposure
- Keywords
- Posttraumatic Stress Disorder (PTSD), Psychotherapy, non-medication treatment, Prolonged Exposure, Transcranial Magnetic Stimulation (TMS), Anxiety Disorders, emotion, emotion regulation, functional MRI, Affective Symptoms
- Medical subject headings
- Stress Disorders, Post-Traumatic, Anxiety Disorders, Emotional Regulation, Affective Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prolonged exposureBehavioural
PE will be delivered in 9-12 90-minute sessions. Therapy will be delivered by PhD-level therapists at Stanford and Palo Alto VA. PE consists of four components: psychoeducation about PTSD symptoms and the behavioral or cognitive factors maintaining it, a brief breathing retraining that can be used as a stress management tool, prolonged imaginal exposure to the trauma memory both within-session and repeated as homework, and prolonged in vivo exposure to avoided scenarios in patients' day-to-day lives.
| Study group | Role | What they receive |
|---|---|---|
| Immediate Prolonged Exposure Treatment | Experimental | Intake procedures include clinician-administered diagnostic battery, cognitive testing, self-report measures of symptoms, and functional imaging scan. Participants in this arm will complete a concurrent TMS/fMRI scan before beginning Prolonged Exposure (PE). PE will be delivered in 9-12 90-minute sessions. Therapy will be delivered by PhD-level therapists at Stanford and Palo Alto VA. Receives: Behavioral: Prolonged exposure |
| Wait list, immediately followed by Prolonged Exposure | No intervention | Intake procedures include clinician-administered diagnostic battery, cognitive testing, self-report measures of symptoms, and functional imaging scan. NOTE: Participants in this arm receive treatment following a waitlist period of 12 weeks. After waitlist, will have a TMS/fMRI scan and then immediately begin Prolonged Exposure treatment. See above for description of Prolonged Exposure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinician Administered PTSD scale (CAPS)
The CAPS is a 30-item structured interview that corresponds to the DSM-IV criteria for PTSD. In addition to assessing the 17 PTSD symptoms, questions target the impact of symptoms on social and occupational functioning, improvement in symptoms since a previous CAPS administration, overall response validity, overall PTSD severity, and frequency and intensity of five associated symptoms (guilt over acts, survivor guilt, gaps in awareness, depersonalization, and derealization). For each item, standardized questions and probes are provided.
Measured: Before and after Prolonged Exposure Treatment, which is expected to take approximately six weeks.
Secondary outcomes (3)
Mood and Anxiety Symptom Questionnaire (MASQ)
Treatment success based on Improvement on subscales of the MASQ, including decreased anxious arousal and decreased anhedonic depression, from pre- to post-treatment assessment
Measured: Before and after Prolonged Exposure Treatment, which is expected to take approximately six weeks.
fMRI-assessed resting connectivity
From pre- to post-treatment, improve will be based on enhanced functional connectivity
Measured: Before and after Prolonged Exposure Treatment, which is expected to take approximately six weeks.
Implicit emotion regulation
Implicit emotion regulation assessed through emotion conflict task performed during functional imaging. Performance based on reaction time and recruitment of emotion regulation regions during the task.
Measured: Assessed 4 times: Before beginning Prolonged Exposure, after the third week of therapy, after the last therapy session (on average 6 weeks after beginning therapy), and 1 month after the end of therapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2012 (estimated)
- Study startSep 2010
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Posttraumatic Stress Disorder (PTSD)Studies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), VA Office of Research and Development
- Responsible party
- Principal investigator, Amit Etkin, Stanford University
- Investigators
- Amit Etkin, M.D., Ph.D., Principal investigator, Stanford UniversityMadeleine S Goodkind, Ph.D., Study director, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01507948
- Sponsor's protocol ID
- SU-10252011-8566
- Status last verified
- Jul 2015
- First submitted
- 14 Dec 2011
- Last updated
- 23 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Fonzo GA, Goodkind MS, Oathes DJ, Zaiko YV, Harvey M, Peng KK, Weiss ME, Thompson AL, Zack SE, Lindley SE, Arnow BA, Jo B, Gross JJ, Rothbaum BO, Etkin A. PTSD Psychotherapy Outcome Predicted by Brain Activation During Emotional Reactivity and Regulation. Am J Psychiatry. 2017 Dec 1;174(12):1163-1174. doi: 10.1176/appi.ajp.2017.16091072. Epub 2017 Jul 18.
PubMed 28715908Fonzo GA, Goodkind MS, Oathes DJ, Zaiko YV, Harvey M, Peng KK, Weiss ME, Thompson AL, Zack SE, Mills-Finnerty CE, Rosenberg BM, Edelstein R, Wright RN, Kole CA, Lindley SE, Arnow BA, Jo B, Gross JJ, Rothbaum BO, Etkin A. Selective Effects of Psychotherapy on Frontopolar Cortical Function in PTSD. Am J Psychiatry. 2017 Dec 1;174(12):1175-1184. doi: 10.1176/appi.ajp.2017.16091073. Epub 2017 Jul 18.
PubMed 28715907
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Neurobiology of Psychotherapy: Emotional Reactivity and Regulation in PTSD
- ClinicalTrials.gov ID
- NCT01507948
- Acronym / sponsor ID
- SU-10252011-8566
- Conditions
- Posttraumatic Stress Disorder (PTSD)
- Keywords
- Posttraumatic Stress Disorder (PTSD), Psychotherapy, non-medication treatment, Prolonged Exposure, Transcranial Magnetic Stimulation (TMS), Anxiety Disorders, emotion, emotion regulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), VA Office of Research and Development
- Study start
- Sep 2010
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 11 Jan 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.
The investigators are seeking people who have been exposed to a traumatic event in the past and have symptoms of posttraumatic stress disorder (PTSD) currently. A person with PTSD may feel significant distress when reminded of a traumatic event or feel depressed, anxious or jumpy.
As a part of this study, participants will receive brain MRIs and office assessments before and after psychotherapy. The investigators provide the gold-standard psychotherapy for PTSD, "Prolonged Exposure", free of charge; additionally participants are compensated for their time during assessment procedures. This study is exploring the brain circuitry involved in improvement in response to psychotherapy.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate Prolonged Exposure Treatment | Experimental | Behavioral: Prolonged exposureIntake procedures include clinician-administered diagnostic battery, cognitive testing, self-report measures of symptoms, and functional imaging scan. Participants in this arm will complete a concurrent TMS/fMRI scan before beginning Prolonged Exposure (PE). PE will be delivered in 9-12 90-minute sessions. Therapy will be delivered by PhD-level therapists at Stanford and Palo Alto VA. |
| Wait list, immediately followed by Prolonged Exposure | No intervention | –Intake procedures include clinician-administered diagnostic battery, cognitive testing, self-report measures of symptoms, and functional imaging scan. NOTE: Participants in this arm receive treatment following a waitlist period of 12 weeks. After waitlist, will have a TMS/fMRI scan and then immediately begin Prolonged Exposure treatment. See above for description of Prolonged Exposure. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- age between 18 and 60 years;
- fMRI scanning eligibility, including no evidence of any form of metal embedded in the body (e.g., metal wires, nuts, bolts, screws, plates, sutures), as these produce artifacts when brain imaging;
- not currently involved in an exposure-based psychotherapy, in order to be able to measure and interpret the effects of PE on PTSD;
- must comprehend English well and show non-impaired intellectual abilities to ensure adequate comprehension of the fMRI task instructions and PE treatment;
- no history of neurological or cardiovascular disorders, brain surgery, electroconvulsive or radiation treatment, brain hemorrhage or tumor, stroke, seizures or epilepsy, diabetes, hypo- or hyperthyroidism, head trauma with loss of consciousness greater than thirty minutes;
Key exclusion criteria (5 listed)
- Any contraindication to being scanned in the 3T or 1.5T scanners at the Lucas Center or CNI such as having a pacemaker or implanted device that has not been cleared for scanning at the Lucas Center or CNI.
- Participants will be excluded from the study if there is any lifetime evidence of psychosis, mania, hypomania, or bipolar disorders. Other axis I comorbidities will not be a cause for exclusion.
- In addition, subjects will be excluded if they have a significant CNS neurological condition such as stroke, seizure, tumor, hemorrhage, multiple sclerosis, etc.
- Patients who have current substance dependence will be excluded from the study. A recent diagnosis of substance abuse is allowable, however, as long as subjects have been abstinent for greater than three months.
- Subjects will be excluded if they are currently in an exposure-based psychotherapy for PTSD.
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 exposurePE will be delivered in 9-12 90-minute sessions. Therapy will be delivered by PhD-level therapists at Stanford and Palo Alto VA. PE consists of four components: psychoeducation about PTSD symptoms and the behavioral or cognitive factors maintaining it, a brief breathing retraining that can be used as a stress management tool, prolonged imaginal exposure to the trauma memory both within-session and repeated as homework, and prolonged in vivo exposure to avoided scenarios in patients' day-to-day lives. | Behavioural | Immediate Prolonged Exposure Treatment |
Primary outcome
Clinician Administered PTSD scale (CAPS)
Time frame: Before and after Prolonged Exposure Treatment, which is expected to take approximately six weeks.
The CAPS is a 30-item structured interview that corresponds to the DSM-IV criteria for PTSD. In addition to assessing the 17 PTSD symptoms, questions target the impact of symptoms on social and occupational functioning, improvement in symptoms since a previous CAPS administration, overall response validity, overall PTSD severity, and frequency and intensity of five associated symptoms (guilt over acts, survivor guilt, gaps in awareness, depersonalization, and derealization). For each item, standardized questions and probes are provided.
3 secondary outcomes
Mood and Anxiety Symptom Questionnaire (MASQ)
Time frame: Before and after Prolonged Exposure Treatment, which is expected to take approximately six weeks.
fMRI-assessed resting connectivity
Time frame: Before and after Prolonged Exposure Treatment, which is expected to take approximately six weeks.
Implicit emotion regulation
Time frame: Assessed 4 times: Before beginning Prolonged Exposure, after the third week of therapy, after the last therapy session (on average 6 weeks after beginning therapy), and 1 month after the end of therapy.
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 23 Jan 2017.
- Derived from this study: PubMed 28715908Fonzo GA, Goodkind MS, Oathes DJ, Zaiko YV, Harvey M, Peng KK, Weiss ME, Thompson AL, Zack SE, Lindley SE, Arnow BA, Jo B, Gross JJ, Rothbaum BO, Etkin A. PTSD Psychotherapy Outcome Predicted by Brain Activation During Emotional Reactivity and Regulation. Am J Psychiatry. 2017 Dec 1;174(12):1163-1174. doi: 10.1176/appi.ajp.2017.16091072. Epub 2017 Jul 18.
- Derived from this study: PubMed 28715907Fonzo GA, Goodkind MS, Oathes DJ, Zaiko YV, Harvey M, Peng KK, Weiss ME, Thompson AL, Zack SE, Mills-Finnerty CE, Rosenberg BM, Edelstein R, Wright RN, Kole CA, Lindley SE, Arnow BA, Jo B, Gross JJ, Rothbaum BO, Etkin A. Selective Effects of Psychotherapy on Frontopolar Cortical Function in PTSD. Am J Psychiatry. 2017 Dec 1;174(12):1175-1184. doi: 10.1176/appi.ajp.2017.16091073. Epub 2017 Jul 18.
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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.
Amit Etkin, M.D., Ph.D. principal investigator
Stanford University
Madeleine S Goodkind, Ph.D. study director
Stanford University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prolonged exposure in people with Posttraumatic Stress Disorder (PTSD), run by Stanford University at 2 sites 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 6 inclusion and 5 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 23 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Clinician Administered PTSD scale (CAPS) (time frame: Before and after Prolonged Exposure Treatment, which is expected to take approximately six weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01507948, which also lists 2 linked publications.
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 23 Jan 2017.