Brain Imaging of Psychotherapy for Posttraumatic Stress Disorder (PTSD)

NCT01507948 | Completed DMC

• 1 other identifier: SU-10252011-8566
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 2

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.

Conditions

Posttraumatic Stress Disorder (PTSD)

Keywords

Posttraumatic Stress Disorder (PTSD); Psychotherapy; non-medication treatment; Prolonged Exposure; Transcranial Magnetic Stimulation (TMS); Anxiety Disorders; emotion; emotion regulation; functional MRI; Affective Symptoms

Outcome Measures

Primary Outcomes (1)

• Clinician Administered PTSD scale (CAPS)

  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.

  Before and after Prolonged Exposure Treatment, which is expected to take approximately six weeks.

Secondary Outcomes (3)

• Mood and Anxiety Symptom Questionnaire (MASQ)

  Before and after Prolonged Exposure Treatment, which is expected to take approximately six weeks.

• fMRI-assessed resting connectivity

  Before and after Prolonged Exposure Treatment, which is expected to take approximately six weeks.

• 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.

Study Arms (2)

Immediate Prolonged Exposure Treatment

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.

Behavioral: Prolonged exposure

Wait list, immediately followed by Prolonged Exposure

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.

Interventions

Prolonged exposure BEHAVIORAL

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.

Immediate Prolonged Exposure Treatment

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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;

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Stanford University: lead
• National Institutes of Health (NIH): collaborator
• VA Office of Research and Development: collaborator

Study Sites (2)

VA Palo Alto Healthcare System

Palo Alto, California, 94304, United States

Location

Stanford University, Department of Psychiatry

Stanford, California, 94304, United States

Location

Related Publications (2)

• Fonzo GA, Goodkind MS, Oathes DJ, Zaiko YV, Harvey M, Peng KK, Weiss ME, Thompson AL, Zack SE, Lindley SE, Arnow BA, Jo B, Gross JJ, Rothbaum BO, Etkin A. PTSD Psychotherapy Outcome Predicted by Brain Activation During Emotional Reactivity and Regulation. Am J Psychiatry. 2017 Dec 1;174(12):1163-1174. doi: 10.1176/appi.ajp.2017.16091072. Epub 2017 Jul 18.

  PMID: 28715908 DERIVED

• Fonzo GA, Goodkind MS, Oathes DJ, Zaiko YV, Harvey M, Peng KK, Weiss ME, Thompson AL, Zack SE, Mills-Finnerty CE, Rosenberg BM, Edelstein R, Wright RN, Kole CA, Lindley SE, Arnow BA, Jo B, Gross JJ, Rothbaum BO, Etkin A. Selective Effects of Psychotherapy on Frontopolar Cortical Function in PTSD. Am J Psychiatry. 2017 Dec 1;174(12):1175-1184. doi: 10.1176/appi.ajp.2017.16091073. Epub 2017 Jul 18.

  PMID: 28715907 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Anxiety Disorders; Emotional Regulation; Affective Symptoms

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Self-Control; Social Behavior; Behavior; Behavioral Symptoms

Study Officials

• Amit Etkin, M.D., Ph.D.

  Stanford University

  PRINCIPAL INVESTIGATOR

• Madeleine S Goodkind, Ph.D.

  Stanford University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 14, 2011
• First Posted: January 11, 2012
• Study Start: September 1, 2010
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: January 23, 2017

Record last verified: 2015-07

Locations

US (2)