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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| VA Office of Research and Development | FED |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prolonged exposure | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Before and after Prolonged Exposure Treatment, which is expected to take approximately six weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Before and after Prolonged Exposure Treatment, which is expected to take approximately six weeks. |
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Inclusion Criteria:
Exclusion Criteria:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Amit Etkin, M.D., Ph.D. | Stanford University | Principal Investigator |
| Madeleine S Goodkind, Ph.D. | Stanford University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Palo Alto Healthcare System | Palo Alto | California | 94304 | United States | ||
| Stanford University, Department of Psychiatry |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28715908 | Derived | 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. | |
| 28715907 |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| D001008 | Anxiety Disorders |
| D000080103 | Emotional Regulation |
| D000342 | Affective Symptoms |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
| D000068356 | Self-Control |
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|
| fMRI-assessed resting connectivity |
From pre- to post-treatment, improve will be based on enhanced functional connectivity |
| 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. | 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. |
| Stanford |
| California |
| 94304 |
| United States |
| Fonzo 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. |
| D012919 | Social Behavior |
| D001519 | Behavior |
| D001526 | Behavioral Symptoms |