Overview

This trial is active, not recruiting.

Condition posttraumatic stress disorder (ptsd)
Treatments prolonged exposure
Sponsor Stanford University
Collaborator National Institutes of Health (NIH)
Start date September 2010
End date November 2015
Trial size 64 participants
Trial identifier NCT01507948, SU-10252011-8566

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.

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose basic science
Arm
(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.
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.
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)
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.

Primary Outcomes

Measure
Clinician Administered PTSD scale (CAPS)
time frame: Before and after Prolonged Exposure Treatment, which is expected to take approximately six weeks.

Secondary Outcomes

Measure
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.

Eligibility Criteria

Male or female participants from 18 years up to 60 years old.

Inclusion Criteria: 1. age between 18 and 60 years; 2. 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; 3. not currently involved in an exposure-based psychotherapy, in order to be able to measure and interpret the effects of PE on PTSD; 4. must comprehend English well and show non-impaired intellectual abilities to ensure adequate comprehension of the fMRI task instructions and PE treatment; 5. 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; 6. 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. Exclusion Criteria: - 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.

Additional Information

Official title The Neurobiology of Psychotherapy: Emotional Reactivity and Regulation in PTSD
Principal investigator Amit Etkin, M.D., Ph.D.
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by Stanford University.