Brain Imaging of Psychotherapy for Posttraumatic Stress Disorder (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.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
|Official Title:||The Neurobiology of Psychotherapy: Emotional Reactivity and Regulation in PTSD|
- Clinician Administered PTSD scale (CAPS) [ Time Frame: Before and after Prolonged Exposure Treatment, which is expected to take approximately six weeks. ] [ Designated as safety issue: No ]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.
- Mood and Anxiety Symptom Questionnaire (MASQ) [ Time Frame: Before and after Prolonged Exposure Treatment, which is expected to take approximately six weeks. ] [ Designated as safety issue: No ]Treatment success based on Improvement on subscales of the MASQ, including decreased anxious arousal and decreased anhedonic depression, from pre- to post-treatment assessment
- fMRI-assessed resting connectivity [ Time Frame: Before and after Prolonged Exposure Treatment, which is expected to take approximately six weeks. ] [ Designated as safety issue: No ]From pre- to post-treatment, improve will be based on enhanced functional connectivity
- 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. ] [ Designated as safety issue: No ]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.
|Study Start Date:||September 2010|
|Estimated Study Completion Date:||November 2015|
|Estimated Primary Completion Date:||November 2015 (Final data collection date for primary outcome measure)|
Experimental: Immediate Prolonged Exposure Treatment
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.
Behavioral: Prolonged exposure
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.
No Intervention: Wait list, immediately followed by Prolonged Exposure
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01507948
|United States, California|
|VA Palo Alto Healthcare System|
|Palo Alto, California, United States, 94304|
|Stanford University, Department of Psychiatry|
|Stanford, California, United States, 94304|
|Principal Investigator:||Amit Etkin, M.D., Ph.D.||Stanford University|
|Study Director:||Madeleine S Goodkind, Ph.D.||Stanford University|