Brain Imaging of Psychotherapy for Posttraumatic Stress Disorder (PTSD)
|ClinicalTrials.gov Identifier: NCT01507948|
Recruitment Status : Completed
First Posted : January 11, 2012
Last Update Posted : January 23, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Posttraumatic Stress Disorder (PTSD)||Behavioral: Prolonged exposure||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||94 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||The Neurobiology of Psychotherapy: Emotional Reactivity and Regulation in PTSD|
|Study Start Date :||September 2010|
|Actual Primary Completion Date :||January 2016|
|Actual Study Completion Date :||January 2016|
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.
- 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.
- Mood and Anxiety Symptom Questionnaire (MASQ) [ Time Frame: Before and after Prolonged Exposure Treatment, which is expected to take approximately six weeks. ]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. ]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. ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|