Brain Imaging of Psychotherapy for Posttraumatic Stress Disorder (PTSD)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2012 by Stanford University
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT01507948
First received: December 14, 2011
Last updated: January 13, 2012
Last verified: January 2012
  Purpose

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 Intervention
Posttraumatic Stress Disorder (PTSD)
Behavioral: Prolonged exposure
Behavioral: Prolonged Exposure

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 64
Study Start Date: September 2010
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01507948

Contacts
Contact: Kathy Peng, B.A. 650-725-9510 psychiatry@stanford.edu
Contact: Madeleine Goodkind, PhD 650-493-5000 ext 60168 mgoodkin@stanford.edu

Locations
United States, California
VA Palo Alto Healthcare System Recruiting
Palo Alto, California, United States, 94304
Contact: Kathy Peng, B.A.    650-725-9510    psychiatry@stanford.edu   
Contact: Madeleine Goodkind, Ph.D.    650-493-5000 ext 60168    mgoodkin@stanford.edu   
Principal Investigator: Amit Etkin, M.D., Ph.D.         
Stanford University, Department of Psychiatry Recruiting
Stanford, California, United States, 94304
Contact: Kathy Peng, B.A.    650-725-9510    psychiatry@stanford.edu   
Contact: Madeleine Goodkind, Ph.D.    650-725-9510    mgoodkin@stanford.edu   
Principal Investigator: Amit Etkin, M.D., Ph.D.         
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Amit Etkin, M.D., Ph.D. Stanford University
Study Director: Madeleine S Goodkind, Ph.D. Stanford University
  More Information

No publications provided

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT01507948     History of Changes
Other Study ID Numbers: SU-10252011-8566
Study First Received: December 14, 2011
Last Updated: January 13, 2012
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by Stanford University:
Posttraumatic Stress Disorder (PTSD)
Psychotherapy
non-medication treatment
Prolonged Exposure
Transcranial Magnetic Stimulation (TMS)
Anxiety Disorders
emotion
emotion regulation
functional MRI
Affective Symptoms

Additional relevant MeSH terms:
Disease
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Pathologic Processes
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 29, 2014