Brain Imaging of Psychotherapy for Posttraumatic Stress Disorder (PTSD)

Sponsor

Stanford University (Other)

Overall Status

Completed

CT.gov ID

NCT01507948

Collaborator

National Institutes of Health (NIH) (NIH), VA Office of Research and Development (U.S. Fed)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Posttraumatic Stress Disorder (PTSD)	Behavioral: Prolonged exposure	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

94 participants

Allocation:

Randomized

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 :

Sep 1, 2010

Actual Primary Completion Date :

Jan 1, 2016

Actual Study Completion Date :

Jan 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

Clinician Administered PTSD scale (CAPS) [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.

Secondary Outcome Measures

Mood and Anxiety Symptom Questionnaire (MASQ) [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 [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	VA Palo Alto Healthcare System	Palo Alto	California	United States	94304
2	Stanford University, Department of Psychiatry	Stanford	California	United States	94304